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deamino arginine vasopressin

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Description

Deamino Arginine Vasopressin: A synthetic analog of the pituitary hormone, ARGININE VASOPRESSIN. Its action is mediated by the VASOPRESSIN receptor V2. It has prolonged antidiuretic activity, but little pressor effects. It also modulates levels of circulating FACTOR VIII and VON WILLEBRAND FACTOR. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID5311065
CHEMBL ID1429
CHEBI ID4450
SCHEMBL ID14027607
MeSH IDM0474041

Synonyms (52)

Synonym
1-(3-mercaptopropionic acid)-8-d-arginine-vasopressin
ddavp
DB00035
1-desamino-8-d-arginine vasopressin
1-deamino-8-d-arginine vasopressin
desmopressine [inn-french]
desmopressinum [inn-latin]
desamino-8-d-arginine vasopressin, l-
einecs 240-726-7
desmopresina [inn-spanish]
desmopressin [inn:ban]
deamino-8-d-arginine, l-, vasopressin
deamino arginine vasopressin
vasopressin, 1-(3-mercaptopropanoic acid)-8-d-arginine-
desmopressinum
CHEBI:4450 ,
desmopresina
1-{[(4r,7s,10s,13s,16s)-7-(2-amino-2-oxoethyl)-10-(3-amino-3-oxopropyl)-13-benzyl-16-(4-hydroxybenzyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentaazacycloicosan-4-yl]carbonyl}-l-prolyl-d-arginylglycinamide
desmopressine
CHEMBL1429 ,
ser-120
h01ba02
ser120
(s)-1-((4r,7s,10s,13s,16s)-7-(2-amino-2-oxoethyl)-10-(3-amino-3-oxopropyl)-13-benzyl-16-(4-hydroxybenzyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentaazacycloicosane-4-carbonyl)-n-((r)-1-(2-amino-2-oxoethylamino)-5-guanidino-1-oxopentan-2-yl)pyrrol
bdbm50205308
enr1llb0fp ,
unii-enr1llb0fp
dtxsid1048259 ,
AKOS015994650
desmopressin [vandf]
desmopressin [mi]
desmopressin [ep monograph]
desmopressin [inn]
desmopressin [mart.]
desmopressin [who-dd]
NFLWUMRGJYTJIN-PNIOQBSNSA-N
HS-2010
SCHEMBL14027607
113-81-5
EX-A4284
AC-35742
STL581697
iaminomethylidene)-d-ornithylglycinamide
1-{[(4r,7s,10s,13s,16s)-7-(2-amino-2-oxoethyl)-10-(3-amino-3-oxopropyl)-13-benzyl-16-(4-hydroxybenzyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentaazacycloicosan-4-yl]carbonyl}-l-prolyl-n~5~-(d
desmopressin (mart.)
(deamino-cys1,d-arg8)vasopressin
desmopressine (inn-french)
desmopressina
desmopresina (inn-spanish)
desmopressin (ep monograph)
desmopressinum (inn-latin)
AKOS040894156

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" Compared with previously available treatments, it has a greatly enhanced therapeutic profile, allowing more specific antidiuresis without adverse reactions."( Clinical experience with desmopressin: efficacy and safety in central diabetes insipidus and other conditions.
Harris, AS, 1989
)
0.28
" No abnormalities were demonstrated, which suggests that the drug is safe in this clinical situation."( Assessment of the safety of regular DDAVP therapy in primary nocturnal enuresis.
Rew, DA; Rundle, JS, 1989
)
0.28
"Desmopressin is a potent antidiuretic for nocturnal enuresis with few and mostly insignificant adverse reactions."( Efficacy, safety, and dosing of desmopressin for nocturnal enuresis in Europe.
Bengtsson, B; Hjälmås, K, 1993
)
0.29
" During the 1-year prospective study with oral DDAVP 300-600 micrograms per day in two to three doses, stable and satisfactory antidiuresis (comparable with that on previous IN therapy) was maintained; tablets were well-tolerated and no side-effect warranted drug withdrawal."( Pharmacokinetics, pharmacodynamics, long-term efficacy and safety of oral 1-deamino-8-D-arginine vasopressin in adult patients with central diabetes insipidus.
Choi, KL; Ip, TP; Kumana, CR; Lam, KS; Pang, RW; Wat, MS, 1996
)
0.29
"Desmopressin could be a safe and immediately effective option for the treatment or prevention of bleeding in selected patients with hematologic malignancies."( Pilot study on the safety and efficacy of desmopressin for the treatment or prevention of bleeding in patients with hematologic malignancies.
Bona, ED; Castaman, G; D'Emilio, A; Rodeghiero, F; Schiavotto, C; Trentin, L,
)
0.13
" These results suggest that repeated short-term iontophoresis is a safe and effective technique for transdermal delivery of DDAVP."( Safe and efficient transdermal delivery of desmopressin acetate by iontophoresis in rats.
Ito, K; Kato, Y; Nakakura, M, 1998
)
0.3
"Oral DDAVP is a safe and efficacious drug for the short-term treatment of children with primary nocturnal enuresis."( Efficacy and safety of oral desmopressin in the treatment of primary nocturnal enuresis in Asian children.
Chao, SM; Low, EH; Murugasu, B; Ong, EK; Tan, AY; Yap, HK, 1998
)
0.3
" In conclusion, DDAVP use during pregnancy seems to be safe for both mother and child."( DDAVP use during pregnancy: an analysis of its safety for mother and child.
Ray, JG, 1998
)
0.3
" No serious drug-related adverse events were recorded and no clinical symptoms of hyponatraemia were reported."( Efficacy and safety during long-term treatment of primary monosymptomatic nocturnal enuresis with desmopressin. Swedish Enuresis Trial Group.
Bergström, R; Fosdal, I; Hjälmås, K; Tullus, K; Winnergård, I, 1999
)
0.3
"We report our experience with the incidence of adverse events during the use of Stimate brand intranasal desmopressin acetate (IN DDAVP) for patients with haemophilia A (HA) or von Willebrand disease (vWD) after noting two severe adverse events in one adult patient."( Adverse events during use of intranasal desmopressin acetate for haemophilia A and von Willebrand disease: a case report and review of 40 patients.
Abshire, TC; Dunn, AL; Powers, JR; Ribeiro, MJ; Rickles, FR, 2000
)
0.31
" Poly I:Poly C itself had no toxic effect on renal tissue, while Poly I:Poly C followed 24 h later by gentamicin indicated a protective effect from the gentamicin nephrotoxicity as the functional and histological investigations indicated."( Protective effect of poly I:poly C from gentamicin nephrotoxicity in guinea pigs.
Gourgiotis, D; Karpathios, T; Kavazarakis, E; Moustaki, M; Nakopoulou, L; Zeis, MP; Zeis, PM, 2001
)
0.31
" Most adverse events (rhinitis, pharyngitis, headache and increased cough) were mild to moderate in severity, unrelated to treatment and resolved before the study was completed."( The efficacy and safety of oral desmopressin in children with primary nocturnal enuresis.
Salzman, PM; Schulman, SL; Stokes, A, 2001
)
0.31
" In general, these alternatives are safe with proper dosing and monitoring of effects."( Safety and efficacy of methods for reducing perioperative allogeneic transfusion: a critical review of the literature.
Wells, PS,
)
0.13
"All 72 enrolled patients completed the trial; no serious adverse events occurred and no adverse events of severe intensity were recorded."( Desmopressin in elderly patients with nocturia: short-term safety and effects on urine output, sleep and voiding patterns.
Andersson, KE; Norgaard, JP; Rembratt, A, 2003
)
0.32
" DDAVP was well tolerated: the majority of reported adverse events were mild, although two adverse events leading to withdrawal were reported."( The Canadian Enuresis Study and Evaluation--short- and long-term safety and efficacy of an oral desmopressin preparation.
Barkin, J; Gorodzinsky, F; Schwarz, R; Wolfish, NM, 2003
)
0.32
"Desmopressin is a safe drug with a low incidence of side-effects."( Desmopressin is a safe drug for the treatment of enuresis.
Auriemma, R; Cennamo, M; Del Gado, G; Del Gado, R; Del Gaizo, D; Vernì, M, 2005
)
0.33
" Herein we review the adverse effects of DDAVP and its predecessor, vasopressin, as well as discuss important clinical considerations when using these agents to treat central diabetes insipidus."( Vasopressin and desmopressin in central diabetes insipidus: adverse effects and clinical considerations.
Allen, M; Kim, RJ; Maghnie, M; Malattia, C; Moshang, T, 2004
)
0.32
"Desmopressin has been used extensively for primary nocturnal enuresis and it is associated with a low incidence of adverse effects."( Desmopressin toxicity due to prolonged half-life in 18 patients with nocturnal enuresis.
Dehoorne, JL; Hoebeke, P; Raes, AM; van Laecke, E; Vande Walle, JG, 2006
)
0.33
" Water intoxication leading to hyponatremia is an infrequent but serious adverse event associated with desmopressin."( The comparative safety of oral versus intranasal desmopressin for the treatment of children with nocturnal enuresis.
Leung, AK; Norgaard, JP; Robson, WL, 2007
)
0.34
" In addition, the product was well tolerated and no adverse events potentially related to the study drug were reported."( Fanhdi, efficacy and safety in von Willebrand's disease: prospective international study results.
Bello, IF; Molina, MQ; Navarro, FH; Yuste, VJ, 2007
)
0.34
"Fanhdi is an effective and safe plasma-derived FVIII/VWF concentrate that can be used as an alternative to the current replacement therapy in patients with VWD to provide an adequate haemostasis during surgical procedures and treatment of bleeding episodes."( Fanhdi, efficacy and safety in von Willebrand's disease: prospective international study results.
Bello, IF; Molina, MQ; Navarro, FH; Yuste, VJ, 2007
)
0.34
" While a large body of clinical data is available for desmopressin, and despite its widespread use, comprehensive reviews of the safety of desmopressin are lacking (although some case series have attempted to correlate patient and/or dosing characteristics with the occurrence of adverse reactions)."( Desmopressin 30 years in clinical use: a safety review.
Nørgaard, JP; Raes, A; Stockner, M; Vande Walle, J, 2007
)
0.34
" There are few serious adverse events reported for the melt formulation (oral lyophilisate), but as it has only recently become available on the market, it would be premature to conclude that it has a better safety profile."( Is there still a role for desmopressin in children with primary monosymptomatic nocturnal enuresis?: a focus on safety issues.
Raes, A; Van de Walle, J; Van Herzeele, C, 2010
)
0.36
" Aim, patients: Due to clinical practice we were interested in finding prospective parameter potentially correlating with adverse reactions of DDAVP and initiated this study."( Clinical assessment of efficacy and safety of DDAVP.
Alesci, SR; Asmelash, G; Dück, O; Grossmann, R; Krekeler, S; Llugaliu, B; Miesbach, W; Schüttrumpf, J, 2010
)
0.36
"Most adverse reactions were mild and no serious adverse drug reactions were either observed or reported by the subjects."( Clinical assessment of efficacy and safety of DDAVP.
Alesci, SR; Asmelash, G; Dück, O; Grossmann, R; Krekeler, S; Llugaliu, B; Miesbach, W; Schüttrumpf, J, 2010
)
0.36
" The adverse effects of desmopressin were similar to those observed in the placebo group."( Efficacy and safety of desmopressin for treatment of nocturia: a systematic review and meta-analysis of double-blinded trials.
Peng, X; Yang, C; Zhang, Y; Zong, H, 2012
)
0.38
"Rate of correction of hyponatremia, predictability of response to the combination, adverse events related to therapy."( Hypertonic saline and desmopressin: a simple strategy for safe correction of severe hyponatremia.
Chen, L; Hix, JK; Silver, SM; Sood, L; Sterns, RH, 2013
)
0.39
" There was no adverse effect associated with therapy."( Hypertonic saline and desmopressin: a simple strategy for safe correction of severe hyponatremia.
Chen, L; Hix, JK; Silver, SM; Sood, L; Sterns, RH, 2013
)
0.39
" Safety was evaluated by hyponatremia, hyponatremic symptoms and other adverse drug events."( Safety and efficacy of desmopressin for the treatment of nocturia in elderly patients: a cohort study.
Choo, MS; Chun, JY; Han, JY; Hong, BS; Song, M, 2014
)
0.4
" Severe adverse events were not observed."( Safety and efficacy of desmopressin for the treatment of nocturia in elderly patients: a cohort study.
Choo, MS; Chun, JY; Han, JY; Hong, BS; Song, M, 2014
)
0.4
"2 mg is safe and effective in elderly patients with NP if patients are well informed and are closely followed up."( Safety and efficacy of desmopressin for the treatment of nocturia in elderly patients: a cohort study.
Choo, MS; Chun, JY; Han, JY; Hong, BS; Song, M, 2014
)
0.4
"Studies were generally of high quality, although 4 used an active run-in period to titrate the dose and exclude patients with adverse effects or who were nonresponders."( A systematic review of the efficacy and safety of desmopressin for nocturia in adults.
Ebell, MH; Gardner, J; Radke, T, 2014
)
0.4
" Endpoints are adverse events and change in body mass index."( Safety profile of desmopressin tablet for enuresis in a prospective study.
De Bruyne, P; Eggert, P; Evans, J; Lottmann, H; Norgaard, JP; Van Herzeele, C; Vande Walle, J, 2014
)
0.4
" At each visit, adverse events were questioned and observed signs or symptoms were recorded."( Safety profile of desmopressin tablet for enuresis in a prospective study.
De Bruyne, P; Eggert, P; Evans, J; Lottmann, H; Norgaard, JP; Van Herzeele, C; Vande Walle, J, 2014
)
0.4
"Overall, 222 (30%) patients experienced 404 treatment-emergent adverse events."( Safety profile of desmopressin tablet for enuresis in a prospective study.
De Bruyne, P; Eggert, P; Evans, J; Lottmann, H; Norgaard, JP; Van Herzeele, C; Vande Walle, J, 2014
)
0.4
" In conclusion, our study supports desmopressin use as a safe treatment option in patients with various bleeding disorders."( Side effects of desmopressin in patients with bleeding disorders.
Cnossen, MH; de Maat, MP; Kruip, MJ; Leebeek, FW; Stoof, SC, 2016
)
0.43
" Other secondary end points and adverse events were evaluated."( Efficacy and Safety of Desmopressin Add-On Therapy for Men with Persistent Nocturia on α-Blocker Monotherapy for Lower Urinary Tract Symptoms: A Randomized, Double-Blind, Placebo Controlled Study.
Cho, KJ; Choo, MS; Kim, DY; Kim, JC; Lee, JG; Lee, JZ; Lee, KS; Oh, SJ; Seo, JT, 2017
)
0.46
" The incidence of adverse events in the desmopressin add-on group was similar to that in the placebo group."( Efficacy and Safety of Desmopressin Add-On Therapy for Men with Persistent Nocturia on α-Blocker Monotherapy for Lower Urinary Tract Symptoms: A Randomized, Double-Blind, Placebo Controlled Study.
Cho, KJ; Choo, MS; Kim, DY; Kim, JC; Lee, JG; Lee, JZ; Lee, KS; Oh, SJ; Seo, JT, 2017
)
0.46
" Of the known adverse drug reactions, hyponatremia remains a major concern especially in patients over 65 years of age."( Desmopressin and nocturnal voiding dysfunction: Clinical evidence and safety profile in the treatment of nocturia.
Chung, E, 2018
)
0.48
" Other adverse events were similar across treatment groups."( Efficacy and Safety of SER120 Nasal Spray in Patients with Nocturia: Pooled Analysis of 2 Randomized, Double-Blind, Placebo Controlled, Phase 3 Trials.
Abrams, S; Cheng, M; Dmochowski, R; Fein, S; Kaminetsky, J; MacDiarmid, S; Wein, A, 2018
)
0.48
" Adverse events (AEs) were also recorded."( Pharmacokinetics and safety profile of desmopressin oral tablet formulations in healthy Chinese subjects under fasting and fed conditions.
Chen, G; Chen, H; Ding, Y; Li, C; Li, X; Liu, B; Liu, C; Liu, J; Niu, J; Shen, Z; Wu, M; Zhang, H; Zhu, X, 2018
)
0.48
" Although non-steroidal anti-inflammatory drugs and opioids are used for the treatment of renal colic, some adverse effects have been reported."( Desmopressin/indomethacin combination efficacy and safety in renal colic pain management: A randomized placebo controlled trial.
Baigi, V; Entezari, P; Hedayatshodeh, M; Jalili, M; Mirfazaelian, H; Shirani, F, 2019
)
0.51
" The number of total adverse events was similar in both desmopressin and control groups [5 trials, RR = 0."( Efficacy and safety of desmopressin in women with nocturia: a systematic review and meta-analysis of randomized controlled trials.
Cai, X; Nie, M; Tian, Y; Wang, K, 2019
)
0.51
"The administration of DDAVP was not associated with adverse safety events, but did not significantly reduce the incidence of hematoma expansion in patients with AU-associated ICH."( The Safety and Efficacy of Desmopressin in Patients With Intracranial Hemorrhage and a History of Alcohol Use.
Berger, K; Gunther, M; Prust, M; Salerno, D; Witenko, CJ, 2022
)
0.72
" A single IV dose of desmopressin adjusted to the patient's weight is safe as pre-PRB bleeding prophylaxis."( Safety of renal biopsy bleeding prophylaxis with desmopressin.
Álvarez Nadal, M; Barrios, RHS; Burguera Vion, V; Cintra Cabrera, M; Elías Triviño, S; Fernández Lucas, M; Ortego, S; Rivera-Gorrin, M; Villa Hurtado, D, 2021
)
0.62
" We aimed to establish a systematic review and meta-analysis to confirm its effect on symptom relief and adverse effects."( The efficacy and safety of desmopressin acetate applied for nocturia in benign prostatic hyperplasia patients: A systematic review and meta-analysis.
Alshayyah, R; Wang, Q; Yang, B, 2022
)
0.72
" Patients treated with desmopressin were at higher risk than the control group for short-term adverse events (P < ."( The efficacy and safety of desmopressin acetate applied for nocturia in benign prostatic hyperplasia patients: A systematic review and meta-analysis.
Alshayyah, R; Wang, Q; Yang, B, 2022
)
0.72
" Some adverse reactions of desmopressin, such as hyponatremia, headache, dizziness and nausea, may be mild and short-term."( The efficacy and safety of desmopressin acetate applied for nocturia in benign prostatic hyperplasia patients: A systematic review and meta-analysis.
Alshayyah, R; Wang, Q; Yang, B, 2022
)
0.72
" Treatment-related adverse effects and nighttime arousal were secondary outcomes."( The Safety and Efficacy of Fluoxetine for the Treatment of Refractory Primary Monosymptomatic Nocturnal Enuresis in Children: A Randomized Placebo-Controlled Trial.
Abdelhalim, A; El-Kenawy, MR; Hashem, A; Helmy, TE; Hussiny, M; Soltan, MA, 2022
)
0.72
"Fluoxetine is safe treatment for refractory primary monosymptomatic nocturnal enuresis in children with good initial response that declines at 12 weeks."( The Safety and Efficacy of Fluoxetine for the Treatment of Refractory Primary Monosymptomatic Nocturnal Enuresis in Children: A Randomized Placebo-Controlled Trial.
Abdelhalim, A; El-Kenawy, MR; Hashem, A; Helmy, TE; Hussiny, M; Soltan, MA, 2022
)
0.72
" The secondary endpoints were to clarify the persistence rate, adverse events, and predictive factors of decreasing nighttime frequency."( Efficacy and safety of desmopressin orally disintegrating tablets 25 and 50 μg in male patients with nocturia: A Japanese real-world multicenter clinical study.
Fujino, K; Hashimoto, J; Hashimoto, K; Ichihara, K; Igarashi, M; Ito, Y; Iwasawa, A; Kimura, M; Kobayashi, K; Kouzen, N; Kyoda, Y; Masumori, N; Miyao, N; Muranaka, I; Nofuji, S; Ogasawara, T; Okada, M; Shibamori, K; Shibuya, A; Shimizu, T; Shinkai, N; Suzuki, N; Tachikawa, K; Takei, F; Tanaka, T; Toyota, T; Uchida, K; Yorozuya, W, 2022
)
0.72
" The reason for discontinuation was mainly the occurrence of adverse events in 67 patients (56."( Efficacy and safety of desmopressin orally disintegrating tablets 25 and 50 μg in male patients with nocturia: A Japanese real-world multicenter clinical study.
Fujino, K; Hashimoto, J; Hashimoto, K; Ichihara, K; Igarashi, M; Ito, Y; Iwasawa, A; Kimura, M; Kobayashi, K; Kouzen, N; Kyoda, Y; Masumori, N; Miyao, N; Muranaka, I; Nofuji, S; Ogasawara, T; Okada, M; Shibamori, K; Shibuya, A; Shimizu, T; Shinkai, N; Suzuki, N; Tachikawa, K; Takei, F; Tanaka, T; Toyota, T; Uchida, K; Yorozuya, W, 2022
)
0.72
"We aim to make desmopressin a safe treatment option for (older) patients at risk for hyponatremia, by introducing a new way of sodium monitoring."( Laying the foundation for enhancing safety of desmopressin in older people: Validation of capillary blood sodium levels.
Delanghe, J; Everaert, K; Maenhout, T; Petrovic, M; Van Laecke, E; Verbakel, I; Weiss, J, 2023
)
0.91
" We provided the first step towards a simple and safe solution for frequent sodium monitoring through a minimal invasive capillary blood collection."( Laying the foundation for enhancing safety of desmopressin in older people: Validation of capillary blood sodium levels.
Delanghe, J; Everaert, K; Maenhout, T; Petrovic, M; Van Laecke, E; Verbakel, I; Weiss, J, 2023
)
0.91

Pharmacokinetics

ExcerptReferenceRelevance
"The pharmacokinetic parameters and biological duration of action of DDAVP were measured in five patients with central diabetes insipidus of differing severity."( Pharmacokinetics of 1-desamino-8-D-arginine vasopressin (DDAVP) in patients with central diabetes insipidus.
Burger, HG; Johnston, CI; Pullan, PT, 1978
)
0.26
" The maximum plasma concentrations of DDAVP, measured with a specific and sensitive RIA method, was dose-dependent and there was not significant difference in time until maximum concentration was obtained or in plasma half-life between the two routes of administration."( Central diabetes insipidus in children. Antidiuretic effect and pharmacokinetics of intranasal and peroral 1-deamino-8-D-arginine vasopressin.
Czernichow, P; Fjellestad-Paulsen, A; Harris, A; Tubiana-Rufi, N, 1987
)
0.27
" Plasma DDAVP levels increased in a dose-dependent fashion and its disappearance from the plasma followed an exponential time course, with a half-life 86 to 142 min."( Antidiuretic effect and pharmacokinetics of oral 1-desamino-8-D-arginine vasopressin. 1. Studies in adults and children.
Dunger, DB; Lewis, RJ; Lightman, SL; Lyon, CC; Taylor, F; Williams, TD, 1986
)
0.27
" After intravenous administration, the half-life of elimination (t1/2) of dDAVP was 78 +/- 10 minutes."( Pharmacokinetics of 1-deamino-8-D-arginine vasopressin after various routes of administration in healthy volunteers.
Fjellestad-Paulsen, A; Höglund, P; Lundin, S; Paulsen, O, 1993
)
0.29
"Plasma desmopressin concentrations were measured throughout each study day to calculate the area under the desmopressin plasma-concentration-time curve to infinity (AUCinf), the maximum plasma desmopressin concentration (Cmax), the time at which Cmax was reached (Tmax) and the time at which plasma desmopressin was first detected (Tlag)."( Effect of food intake on the pharmacokinetics and antidiuretic activity of oral desmopressin (DDAVP) in hydrated normal subjects.
Jensen, AR; Jensen, KT; Pedersen, EB; Rittig, S, 1998
)
0.3
" To assess whether the kinetic characteristics and recovery of high purity, plasma-derived (Monoclate-P, Centeon) and recombinant (Bioclate , Centeon) FVIII concentrates are enhanced by increased plasma vWf concentrations, we compared the pharmacokinetic response to a bolus of FVIII infused alone with the response to a bolus infused 2 h after the intranasal delivery of 300 microg of desmopressin acetate (DDAVP) High Concentration Nasal Spray (Stimate, Centeon) in 10 adult severe haemophiliacs."( Intranasal DDAVP induced increases in plasma von Willebrand factor alter the pharmacokinetics of high-purity factor VIII concentrates in severe haemophilia A patients.
Deitcher, SR; Johnson, JA; Tuller, J, 1999
)
0.3
" Individual plasma desmopressin-vWF and desmopressin-FVIII:C concentration/response-time data were fitted to a pharmacodynamic sigmoid E ( max ) model linked to a two-compartment open pharmacokinetic model (Ke0 link)."( The pharmacokinetics and pharmacodynamics of desmopressin: effect on plasma factor VIII:C and von Willebrand factor.
Argenti, D; Heald, D; Jensen, BK, 1997
)
0.3
"We performed a crossover study to determine the relative pharmacokinetic bioavailability and antidiuretic activity of desmopressin in 16 orally hydrated, healthy human subjects."( A pharmacokinetic and pharmacodynamic comparison of desmopressin administered as whole, chewed and crushed tablets, and as an oral solution.
Argenti, D; Heald, DL; Ireland, D, 2001
)
0.31
" Serial plasma samples were collected for 12 hours for desmopressin pharmacokinetic analysis."( A pharmacokinetic and pharmacodynamic comparison of desmopressin administered as whole, chewed and crushed tablets, and as an oral solution.
Argenti, D; Heald, DL; Ireland, D, 2001
)
0.31
" The plasma concentration of desmopressin was followed for 26 hr during and after the infusion and the pharmacokinetic parameters were estimated by compartmental analysis."( Pharmacokinetics and antidiuretic effect of high-dose desmopressin in patients with chronic renal failure.
Björkman, S; Lethagen, S; Ruzicka, H; Sterner, G, 2003
)
0.32
" In order to investigate the clearance of VWF in Type 1 VWD, the current study assessed the half-life of VWF antigen (t(1/2) VWF:Ag) in Type 1 VWD patients and individuals with mild hemophilia A following the administration of 1-deamino-8-d-arginine vasopressin (DDAVP; desmopressin)."( Increased clearance of von Willebrand factor antigen post-DDAVP in Type 1 von Willebrand disease: is it a potential pathogenic process?
Bowen, DJ; Brown, SA; Collins, PW; Eldridge, A, 2003
)
0.32
"To investigate (1) the pharmacokinetic and pharmacodynamic profiles of desmopressin in men from an age group with a high incidence of nocturia; and (2) circadian variation in the pharmacokinetic parameters."( Pharmacokinetics and pharmacodynamics of desmopressin administered orally versus intravenously at daytime versus night-time in healthy men aged 55-70 years.
Djurhuus, JC; Graugaard-Jensen, C; Norgaard, JP; Rembratt, A; Senderovitz, T, 2004
)
0.32
" Pharmacokinetic parameters were derived using a two-compartmental model except for AUC(0-->t), which was derived using non-compartmental analysis."( Pharmacokinetics and pharmacodynamics of desmopressin administered orally versus intravenously at daytime versus night-time in healthy men aged 55-70 years.
Djurhuus, JC; Graugaard-Jensen, C; Norgaard, JP; Rembratt, A; Senderovitz, T, 2004
)
0.32
"The pharmacokinetic profile of desmopressin is biexponential."( Pharmacokinetics and pharmacodynamics of desmopressin administered orally versus intravenously at daytime versus night-time in healthy men aged 55-70 years.
Djurhuus, JC; Graugaard-Jensen, C; Norgaard, JP; Rembratt, A; Senderovitz, T, 2004
)
0.32
" Eight healthy males and eight healthy females participated in the trial, which was conducted in a pharmacokinetic (PK) part followed by a pharmacodynamic (PD) part."( A pharmacokinetic and pharmacodynamic study of desmopressin: evaluating sex differences and the effect of pre-treatment with piroxicam, and further validation of an indirect response model.
Callréus, T; Höglund, P; Lundin, S; Odeberg, JM; Roth, EB, 2004
)
0.32
"To investigate the pharmacokinetic profile of oral desmopressin in elderly patients with nocturia, and to analyse any possible correlation between the absorption and clinical effect."( The pharmacokinetics of 400 microg of oral desmopressin in elderly patients with nocturia, and the correlation between the absorption of desmopressin and clinical effect.
Djurhuus, JC; Hvistendahl, GM; Nørgaard, JP; Riis, A, 2005
)
0.33
"In all, 32 patients were screened to determine the baseline number of nocturnal voids and the nocturia index; of these, 24 fulfilled the inclusion criteria and were enrolled for a pharmacokinetic evaluation of oral desmopressin 400 microg."( The pharmacokinetics of 400 microg of oral desmopressin in elderly patients with nocturia, and the correlation between the absorption of desmopressin and clinical effect.
Djurhuus, JC; Hvistendahl, GM; Nørgaard, JP; Riis, A, 2005
)
0.33
" Plasma desmopressin at 2 h after dosing cannot be used to predict the pharmacodynamic response, although desmopressin lowers the nocturnal diuresis and the number of nocturnal voids."( The pharmacokinetics of 400 microg of oral desmopressin in elderly patients with nocturia, and the correlation between the absorption of desmopressin and clinical effect.
Djurhuus, JC; Hvistendahl, GM; Nørgaard, JP; Riis, A, 2005
)
0.33
"To determine the pharmacodynamic properties of a new oral lyophilisate formulation of desmopressin (in single doses of 30, 60, 120, 240, 360 or 480 microg) in children with known primary nocturnal enuresis (PNE) and thus identify those dosages that could provide a duration of action corresponding to a typical length of night-time sleep in children with PNE; additional objectives were to determine the safety and tolerability of desmopressin in this population."( A new fast-melting oral formulation of desmopressin: a pharmacodynamic study in children with primary nocturnal enuresis.
Bogaert, GA; Deboe, V; Hoebeke, P; Mattsson, S; Norgaard, JP; Schurmans, T; Vande Walle, JG, 2006
)
0.33
"All 72 participants receiving desmopressin had a pharmacodynamic response to the drug, while there was no change in urinary output in the 12 placebo-treated patients."( A new fast-melting oral formulation of desmopressin: a pharmacodynamic study in children with primary nocturnal enuresis.
Bogaert, GA; Deboe, V; Hoebeke, P; Mattsson, S; Norgaard, JP; Schurmans, T; Vande Walle, JG, 2006
)
0.33
" A sublingual dose of 240 microg of desmopressin appeared to result in a pharmacokinetic profile comparable to 20 microg administered intranasally."( Plasma pharmacokinetics of desmopressin following sublingual administration: an exploratory dose-escalation study in healthy male volunteers.
Joukhadar, C; Kaehler, ST; Müller, M; Rinösl, H; Sauermann, R; Steiner, IM, 2006
)
0.33
" The pharmacokinetic difference was minor and presumably of no clinical relevance."( Pharmacokinetics of desmopressin administrated as an oral lyophilisate dosage form in children with primary nocturnal enuresis and healthy adults.
Agersø, H; Karlsson, MO; Nørgaard, JP; Osterberg, O; Savic, RM; Simonsson, US; Walle, JV, 2006
)
0.33
" While the poor pharmacokinetic characteristics of the different available formulations may have a role in apparent therapy resistance, there are limited data available to support this theory."( Evidence of partial anti-enuretic response related to poor pharmacodynamic effects of desmopressin nasal spray.
De Guchtenaere, A; Donckerwolcke, R; Hoebeke, P; Raes, A; Van Laecke, E; Vande Walle, C; Vande Walle, J, 2009
)
0.35
" Also the time to reach maximal antidiuretic effect and the duration of pharmacodynamic action show a wide range, requiring individualization of mode and time of administration."( Evidence of partial anti-enuretic response related to poor pharmacodynamic effects of desmopressin nasal spray.
De Guchtenaere, A; Donckerwolcke, R; Hoebeke, P; Raes, A; Van Laecke, E; Vande Walle, C; Vande Walle, J, 2009
)
0.35
" Different formulations are promoted as bioequivalent, although these claims are not supported by comparative pharmacodynamic data in children."( Oral lyophylizate formulation of desmopressin: superior pharmacodynamics compared to tablet due to low food interaction.
De Guchtenaere, A; Dehoorne, J; Hoebeke, P; Raes, A; Van Herzeele, C; Van Laecke, E; Vande Walle, J, 2011
)
0.37
"With meal combination desmopressin melt formulation has a superior pharmacodynamic profile to tablet, making it more suitable for the younger age group with a limited interval between meal and drug administration."( Oral lyophylizate formulation of desmopressin: superior pharmacodynamics compared to tablet due to low food interaction.
De Guchtenaere, A; Dehoorne, J; Hoebeke, P; Raes, A; Van Herzeele, C; Van Laecke, E; Vande Walle, J, 2011
)
0.37
" However, no comparative pharmacokinetic study in children was executed confirming this statement."( Pharmacokinetics of desmopressin administered as tablet and oral lyophilisate formulation in children with monosymptomatic nocturnal enuresis.
De Bruyne, P; De Guchtenaere, A; Dehoorne, J; Hoebeke, P; Raes, A; Van Herzeele, C; Van Laecke, E; Vande Walle, J, 2014
)
0.4
"Previously published data from two studies (one in 22 children aged 6-16 years, and the other in 25 children aged 6-13 years) were analyzed using population pharmacokinetic modeling."( Effects of Food and Pharmaceutical Formulation on Desmopressin Pharmacokinetics in Children.
Boussery, K; Colin, P; De Bruyne, P; Dossche, L; Michelet, R; Van Bocxlaer, J; Vande Walle, J; Vermeulen, A, 2016
)
0.43
" However recent studies have shown that macrophages play a critical role in regulating the half-life of VWF, and have identified specific lectin (including asialoglycoprotein, macrophage galactose-type lectin, Sigec-5 and C-type lectin domain family 4 member M) and scavenger receptors (including low-density lipoprotein receptor-related protein-1, scavenger receptor A1 and stabilin-2) that are involved in VWF clearance."( von Willebrand factor clearance - biological mechanisms and clinical significance.
Lavin, M; O'Donnell, JS; O'Sullivan, JM; Ward, S, 2018
)
0.48
"To study the pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of desmopressin (dDAVP) oral lyophilisate in children below the age of 8 years with special emphasis on age-related and size-related differences in bioavailability."( Desmopressin oral lyophilisate in young children: new insights in pharmacokinetics and pharmacodynamics.
De Bruyne, P; Dossche, L; Gasthuys, E; Michelet, R; Rittig, S; Van Herzeele, C; Vande Walle, J; Vermeulen, A, 2021
)
0.62
" The aim of this study was to develop a pharmacokinetic (PK) model to describe, quantify, and explain this variability."( Population Pharmacokinetic Modeling of von Willebrand Factor Activity in von Willebrand Disease Patients after Desmopressin Administration.
Cnossen, MH; de Jager, NCB; Heijdra, JM; Kieboom, Q; Kruip, MJHA; Leebeek, FWG; Mathôt, RAA, 2020
)
0.56
" Therefore, population pharmacokinetic (PK) models have been developed, which aim to quantify and explain intraindividual and interindividual differences in treatment response."( Is pharmacokinetic-guided dosing of desmopressin and von Willebrand factor-containing concentrates in individuals with von Willebrand disease or low von Willebrand factor reliable and feasible? A protocol for a multicentre, non-randomised, open label coho
Al Arashi, W; Bukkems, LH; Cloesmeijer, ME; Cnossen, MH; de Jager, NCB; Heijdra, JM; Leebeek, FWG; Mathôt, RAA; Zwaan, CM, 2022
)
0.72

Compound-Compound Interactions

ExcerptReferenceRelevance
"A double-blind, placebo controlled study of alarm therapy combined with desmopressin for children with nocturnal enuresis is described."( Efficacy of desmopressin combined with alarm therapy for monosymptomatic nocturnal enuresis.
Blom, J; Leebeek-Groenewegen, A; Sukhai, R; Van Der Heijden, B, 2001
)
0.31
"There is a temporary, positive effect on enuresis using desmopressin combined with alarm therapy."( Efficacy of desmopressin combined with alarm therapy for monosymptomatic nocturnal enuresis.
Blom, J; Leebeek-Groenewegen, A; Sukhai, R; Van Der Heijden, B, 2001
)
0.31
" Here, we explored the antitumor effects of desmopressin in combination with chemotherapeutic agents using the F3II mammary carcinoma in syngeneic Balb/c mice."( Antitumor effects of desmopressin in combination with chemotherapeutic agents in a mouse model of breast cancer.
Alonso, DF; Giron, S; Gomez, DE; Hermo, GA; Krzymuski, MJ; Ripoll, GV,
)
0.13
" Desmopressin in combination with a fixed dose anticholinergic has been shown to be useful in individuals who fail desmopressin monotherapy, but still fails to achieve success rates greater than 60%."( Evaluating use of higher dose oxybutynin in combination with desmopressin for refractory nocturnal enuresis.
Berkenwald, A; Ellsworth, P; Pires, J, 2016
)
0.43
"The use of escalating doses of oxybutynin in combination with desmopressin achieved an overall response rate of 96."( Evaluating use of higher dose oxybutynin in combination with desmopressin for refractory nocturnal enuresis.
Berkenwald, A; Ellsworth, P; Pires, J, 2016
)
0.43
"7% with titrated doses of oxybutynin in combination with desmopressin is considerably higher than the response rates on fixed dose combination therapy quoted in the literature and supports the need for further evaluation in larger studies."( Evaluating use of higher dose oxybutynin in combination with desmopressin for refractory nocturnal enuresis.
Berkenwald, A; Ellsworth, P; Pires, J, 2016
)
0.43
" Herein we present a case of drug-drug interaction (meloxicam and desmopressin), in a patient also on clozapine, that ultimately resulted in hyponatremia and seizure."( Meloxicam-desmopressin drug-drug interaction producing hyponatremia.
Bojdani, E; Buonocore, S; Chen, A; Gurrera, R; Li, KJ, 2019
)
0.51
"In a patient with higher ADH levels, as in our patient taking desmopressin, the addition of an NSAID could further increase water retention and worsen hyponatremia; indeed, meloxicam was the only new medication added to the patient's regimen, and a drug interaction calculator supports the desmopressin-meloxicam drug-drug interaction as the culprit."( Meloxicam-desmopressin drug-drug interaction producing hyponatremia.
Bojdani, E; Buonocore, S; Chen, A; Gurrera, R; Li, KJ, 2019
)
0.51

Bioavailability

ExcerptReferenceRelevance
"The Ussing chamber technique was used as an oral absorption model for studies of the relative effects of the inhibition of enzymatic degradation and increased paracellular route on the transport of the poorly absorbed vasopressin analogues lysine vasopressin (LVP) and desmopressin (DDAVP)."( Effects of enzymatic inhibition and increased paracellular shunting on transport of vasopressin analogues in the rat.
Andreasson, A; Lundin, K; Ungell, AL; Utter, L, 1992
)
0.28
" Plasma DDAVP concentration/time curves conformed closely with zero-order kinetics, which suggests that the bioavailability approached 100%, corresponding to that for direct intravenous infusion."( Administration of antidiuretic peptide (DDAVP) by way of suction de-epithelialised skin.
Lundin, S; Svedman, C; Svedman, P, 1991
)
0.28
" Plasma levels showed that desmopressin was absorbed to a greater extent after administration of the spray with a 2 to 3-fold increase in the relative bioavailability compared with the drops."( Intranasal administration of peptides: nasal deposition, biological response, and absorption of desmopressin.
Alkner, U; Harris, AS; Nilsson, IM; Wagner, ZG, 1986
)
0.27
" At the DDAVP dosage used in this study and currently recommended for therapy, the VIII:C response is neither a function of the rate of absorption of the compound nor of the magnitude of its plasma concentration."( Intravenous and subcutaneous administration of desmopressin (DDAVP) to hemophiliacs: pharmacokinetics and factor VIII responses.
Alberca, I; Harris, AS; Lindquist, A; Longo, G; Mannucci, PM; Sacchi, E; Vicente, V, 1987
)
0.27
"The effects of concentration and dose volume on the nasal bioavailability and biological response to desmopressin [DDAVP; 1-(3-mercaptoproprionic acid)-8-D-arginine vasopressin] were investigated in humans."( Effects of concentration and volume on nasal bioavailability and biological response to desmopressin.
Harris, AS; Lethagen, S; Nilsson, IM; Ohlin, M, 1988
)
0.27
" Radioimmunoassay of DDAVP in blood samples made it possible to calculate bioavailability of DDAVP after the two forms of administration."( Biological effect and plasma concentrations of DDAVP after intranasal and peroral administration to humans.
Lundin, S; Vilhardt, H, 1986
)
0.27
" The bioavailability after nasal administration was found to be 13 times higher in the rat model."( Nasal absorption of desmopressin in rats and sheep. Effect of a bioadhesive microsphere delivery system.
Critchley, H; Davis, SS; Farraj, NF; Illum, L, 1994
)
0.29
" The improved bioavailability resulted from an increased absorption from the small intestine and most likely from an increased stability toward enzymatic degradation, whereas plasma clearance was either unaffected or slightly increased by the glycosylation."( Glycosylated peptide hormones: pharmacological properties and conformational studies of analogues of [1-desamino,8-D-arginine]vasopressin.
Ahman, J; Bengtsson, B; Drakenberg, T; Kihlberg, J; Nilsson, A; Olsson, H; Söderberg-ahlm, C; Walse, B, 1995
)
0.29
" However, the bioavailability of intranasal dDAVP is about 10% and may be modified by nasal congestion."( Renal concentrating capacity test by desmopressin in children: intranasal or intravenous route?
Cochat, P; Dubourg, L; Feber, J; Hadj-Aïssa, A; Pozet, N; Wright, C, 1993
)
0.29
"The absolute bioavailability of an aqueous solution of 1-deamino-8-D-arginine vasopressin (dDAVP) from different regions of the gastrointestinal (GI) tract (stomach, duodenum, jejunum, ileum, colon, rectum) has been studied in 6 healthy, male volunteers aged 24 to 35 years, followed for 12 h after each drug administration."( Absolute bioavailability of an aqueous solution of 1-deamino-8-D-arginine vasopressin from different regions of the gastrointestinal tract in man.
d'Agay-Abensour, L; Fjellestad-Paulsen, A; Höglund, P; Ngô, Y; Paulsen, O; Rambaud, JC, 1993
)
0.29
"Various aliphatic carboxylic acid esters and a carbonate ester of the tyrosine phenolic group in desmopressin were synthesized to assess their suitability as prodrugs with improved bioavailability compared to the parent peptide."( Prodrugs of peptides. 18. Synthesis and evaluation of various esters of desmopressin (dDAVP).
Bundgaard, H; Buur, A; Kahns, AH, 1993
)
0.29
"The bioavailability of dDAVP seems lower than previously reported after intranasal and oral administration."( Pharmacokinetics of 1-deamino-8-D-arginine vasopressin after various routes of administration in healthy volunteers.
Fjellestad-Paulsen, A; Höglund, P; Lundin, S; Paulsen, O, 1993
)
0.29
"The bioavailability from the gastrointestinal tract of peptides as large as nonapeptides is very low, which may be attributed to extensive lumenal and mucosal degradation."( Metabolism of vasopressin, oxytocin, and their analogues in the human gastrointestinal tract.
Fjellestad-Paulsen, A; Lundin, S; Söderberg-Ahlm, C, 1995
)
0.29
"Formulations of MA-SME were shown to generate substantial enhancement (up to 12-fold) of the rat oral bioavailability of DDAVP with regard to simple saline solution of the drug."( Improved oral delivery of desmopressin via a novel vehicle: mucoadhesive submicron emulsion.
Amselem, S; Friedman, D; Ilan, E; Schwarz, J; Weisspapir, M; Yogev, A; Zawoznik, E, 1996
)
0.29
"The bioavailability of an aqueous solution of 1-deamino-8-D-arginine vasopressin (dDAVP), with and without an enzyme inhibitor, was studied in six healthy, male volunteers aged 19-34 years, followed for 8 h after each drug administration."( Bioavailability of 1-deamino-8-D-arginine vasopressin with an enzyme inhibitor (aprotinin) from the small intestine in healthy volunteers.
d'Agay-Abensour, L; Fjellestad-Paulsen, A; Höglund, P; Rambaud, JC, 1996
)
0.29
"The bioavailability and pharmacokinetics of desmopressin (Minirin, DDAVP) have been studied in elderly males, aged between 55 and 75 years."( Bioavailability and pharmacokinetics of desmopressin in elderly men.
Djurhuus, JC; Hougaard, C; Matthiesen, TB; Rittig, S, 1997
)
0.3
" All lipid vehicles enhanced the oral bioavailability of dDAVP, but monohexanoin gave the highest increase, approximately 10 times that of control."( Enhancing effects of monohexanoin and two other medium-chain glyceride vehicles on intestinal absorption of desmopressin (dDAVP).
Bojrup, M; Ljusberg-Wahren, H; Lundin, PD; Lundin, S; Weström, BR, 1997
)
0.3
" Desmopressin bioavailability was increased after treatment with the test preparation (mean ratio of 130."( A comparative study of pharmacodynamics and bioavailability of 2 different desmopressin nasal sprays.
Eller, N; Hitzenberger, G; Kollenz, CJ, 1998
)
0.3
" The oral bioavailability of desmopressin is limited due both to its high hydrophilicity leading to a low intestinal permeability and to low enzymatic stability."( alpha-Chymotrypsin-catalyzed degradation of desmopressin (dDAVP): influence of pH, concentration and various cyclodextrins.
Fredholt, K; Friis, GJ; Ostergaard, J; Savolainen, J, 1999
)
0.3
"We performed a crossover study to determine the relative pharmacokinetic bioavailability and antidiuretic activity of desmopressin in 16 orally hydrated, healthy human subjects."( A pharmacokinetic and pharmacodynamic comparison of desmopressin administered as whole, chewed and crushed tablets, and as an oral solution.
Argenti, D; Heald, DL; Ireland, D, 2001
)
0.31
" Bioavailability was estimated using AUC(0-->t) for the oral and the intravenous periods."( Pharmacokinetics and pharmacodynamics of desmopressin administered orally versus intravenously at daytime versus night-time in healthy men aged 55-70 years.
Djurhuus, JC; Graugaard-Jensen, C; Norgaard, JP; Rembratt, A; Senderovitz, T, 2004
)
0.32
" Bioavailability was as high as 85% and showed acceptable variability (30%)."( Transdermal delivery of desmopressin using a coated microneedle array patch system.
Ameri, M; Cormier, M; Daddona, P; Johnson, B; Libiran, L; Nyam, K; Zhang, DD, 2004
)
0.32
" In addition to poor compliance and suboptimal dosing, the poor bioavailability of intranasal desmopressin may be a pathogenic factor."( Partial response to intranasal desmopressin in children with monosymptomatic nocturnal enuresis is related to persistent nocturnal polyuria on wet nights.
Dehoorne, J; Donckerwolcke, R; Hoebeke, P; Raes, A; Van Laecke, E; Vande Walle, C; Vande Walle, J; Vansintjan, P, 2007
)
0.34
" Of these peptides, the most commonly used is desmopressin, which displays poor bioavailability as well as potent activity at the V(1b) receptor, with possible stress-related adverse effects."( Identification of novel selective V2 receptor non-peptide agonists.
Bertozzi, SM; Brann, MR; Burstein, ES; Currier, EA; Davis, RE; Del Tredici, AL; Knapp, AE; Lameh, J; Mohell, N; Nash, NR; Olsson, R; Piu, F; Vanover, KE, 2008
)
0.35
" If a correlation existed between these data and in vivo DDAVP bioavailability after nasal administration, this could strengthen the safety concerns related to the use of this medication in adults and children."( In vitro permeation of desmopressin across rabbit nasal mucosa from liquid nasal sprays: the enhancing effect of potassium sorbate.
Balducci, AG; Bortolotti, F; Colombo, G; Fabio, S; Fabrizio, B; Gaia, C; Giulia, BA; Paola, R; Russo, P; Sonvico, F, 2009
)
0.35
"1 min; the extents of bioavailability were 72."( Two-layered dissolving microneedles for percutaneous delivery of peptide/protein drugs in rats.
Fukushima, K; Hasegawa, R; Ise, A; Ito, Y; Morita, H; Sugioka, N; Takada, K, 2011
)
0.37
" Food interaction is known to influence the bioavailability of desmopressin."( Oral lyophylizate formulation of desmopressin: superior pharmacodynamics compared to tablet due to low food interaction.
De Guchtenaere, A; Dehoorne, J; Hoebeke, P; Raes, A; Van Herzeele, C; Van Laecke, E; Vande Walle, J, 2011
)
0.37
" Research on desmopressin bioavailability in children is needed."( Reduced anti-diuretic response to desmopressin during wet nights in patients with monosymptomatic nocturnal enuresis.
Andersen, RF; Hagstroem, S; Kamperis, K; Rittig, S; Tauris, LH, 2012
)
0.38
"In the present study, a nasal powder of the antidiuretic peptide desmopressin (DDAVP) formulated as chimera agglomerates was studied to improve drug bioavailability and provide a flexible drug product."( Antidiuretic effect of desmopressin chimera agglomerates by nasal administration in rats.
Balducci, AG; Bortolotti, F; Colombo, G; Colombo, P; Ferraro, L; Nastruzzi, C; Russo, P; Sonvico, F, 2013
)
0.39
" In all cases, the appropriate dose should be determined by titration, owing to considerable interindividual differences in bioavailability and antidiuretic effect."( Clinical review: Treatment of neurohypophyseal diabetes insipidus.
Juul, KV; Nørgaard, JP; Oiso, Y; Robertson, GL, 2013
)
0.39
" No data are available on the influence of food intake on the bioavailability of desmopressin tablet in a pediatric setting, although studies in adults have documented that food intake results in a significantly lower desmopressin plasma concentration."( Pharmacokinetics of desmopressin administered as tablet and oral lyophilisate formulation in children with monosymptomatic nocturnal enuresis.
De Bruyne, P; De Guchtenaere, A; Dehoorne, J; Hoebeke, P; Raes, A; Van Herzeele, C; Van Laecke, E; Vande Walle, J, 2014
)
0.4
" Simulations were subsequently performed to further explore the relative bioavailability of both formulations and the food effect."( Effects of Food and Pharmaceutical Formulation on Desmopressin Pharmacokinetics in Children.
Boussery, K; Colin, P; De Bruyne, P; Dossche, L; Michelet, R; Van Bocxlaer, J; Vande Walle, J; Vermeulen, A, 2016
)
0.43
"1 % more available than the tablet, and fasted children exhibited an average increase in the relative bioavailability of 101 % in comparison with fed children."( Effects of Food and Pharmaceutical Formulation on Desmopressin Pharmacokinetics in Children.
Boussery, K; Colin, P; De Bruyne, P; Dossche, L; Michelet, R; Van Bocxlaer, J; Vande Walle, J; Vermeulen, A, 2016
)
0.43
"To address targeting and bioavailability issues of peptidic drugs like desmopressin, the encapsulation into nanoparticles (NP) has become standard in pharmaceutics."( Influence of different stabilizers on the encapsulation of desmopressin acetate into PLGA nanoparticles.
Günday Türeli, N; Primavessy, D; Schneider, M, 2017
)
0.46
" PK and bioavailability parameters were calculated."( Pharmacokinetics and safety profile of desmopressin oral tablet formulations in healthy Chinese subjects under fasting and fed conditions.
Chen, G; Chen, H; Ding, Y; Li, C; Li, X; Liu, B; Liu, C; Liu, J; Niu, J; Shen, Z; Wu, M; Zhang, H; Zhu, X, 2018
)
0.48
" Simulations were performed to further explore the relative bioavailability of both formulations and evaluate current dosing strategies."( An Integrated Paediatric Population PK/PD Analysis of dDAVP: How do PK Differences Translate to Clinical Outcomes?
De Bruyne, P; Dossche, L; Gasthuys, E; Michelet, R; Van Bocxlaer, J; Van Herzeele, C; Vande Walle, J; Vermeulen, A, 2020
)
0.56
" Regarding the pharmacokinetics, a profound food effect on the oral bioavailability was demonstrated as well as different plasma concentration-time profiles (double absorption peak) of the desmopressin lyophilizate between adults and children."( Pediatric Pharmacology of Desmopressin in Children with Enuresis: A Comprehensive Review.
Croubels, S; Devreese, M; Dossche, L; Gasthuys, E; Michelet, R; Nørgaard, JP; Van Bocxlaer, J; Vermeulen, A; Walle, JV, 2020
)
0.56
" The absorption rate for 2 h was examined following the intravenous administration of the anticholinergics imidafenacin (IM), atropine (AT), and tolterodine (TO)."( Urinary reabsorption in the rat kidney by anticholinergics.
Aoki, Y; Ito, H; Kobayashi, H; Oe, H; Yokoyama, O; Yoshiki, H; Zha, X, 2021
)
0.62
" Correspondingly, oral peptide drug absorption and bioavailability may be impacted."( Do Macrocyclic Peptide Drugs Interact with Bile Salts under Simulated Gastrointestinal Conditions?
Dening, TJ; Douglas, JT; Hageman, MJ, 2021
)
0.62
" A new VWF A1-domain binding aptamer, BT200, demonstrated good subcutaneous bioavailability and a long half-life in non-human primates."( The von Willebrand factor A-1 domain binding aptamer BT200 elevates plasma levels of von Willebrand factor and factor VIII: a first-in-human trial.
Beliveau, M; Bileck, A; Derhaschnig, U; Firbas, C; Gager, G; Gelbenegger, G; Gilbert, JC; Grafeneder, J; Jilma, B; Jilma-Stohlawetz, P; Kovacevic, KD; Quehenberger, P; Schörgenhofer, C; Zhu, S, 2022
)
0.72

Dosage Studied

ExcerptRelevanceReference
" dosage (0."( 1-Deamino-8-d-arginine vasopressin: a new pharmacological approach to the management of haemophilia and von Willebrands' diseases.
Capitanio, A; Mannucci, PM; Pareti, FI; Ruggeri, ZM, 1977
)
0.26
" Twenty-one patients with central diabetes insipidus who ranged in age from 3 to 68 years were treated with DDAVP, which was administered intranasally in a dosage ranging from 10 microgram every 12 hours to 20 microgram every eight hours."( Treatment of central diabetes insipidus in adults and children with desmopressin.
Rosenthal, IM; Walter, R; Ziai, F, 1978
)
0.26
" Further increase of dosage resulted only in prolongation of duration of action (up to 48 hrs) and peak ("plateau") effect (up to 24 hrs)."( The antidiuretic action of 1-deamino-8-D-arginine vasopressin (DDAVP) in man.
Borbély, L; Fischer, J; Marosi, J; Radó, JP; Szende, L; Takó, J, 1976
)
0.26
" The DDAVP tables were administered at the dosage of 400-600 micrograms/day in 2-3 administrations."( [Long-term treatment of central diabetes insipidus with oral DDAVP].
Bernareggi, V; Carraro, A; Cuttica, M; Fano, M; Giordano, G; Giusti, M,
)
0.13
" According to the results of the study desmopressin should be administered at a higher dosage than 300 micrograms/die to obtain the same antidiuretic effect as with the intranasal administration."( [Clinical evaluation of desmopressin (DDAVP) in diabetes insipidus: solution vs tablets].
Boscaro, M; Mantero, F; Piccitto, R; Rampazzo, AL,
)
0.13
" The right dosage of DDAVP tablets was between 150 and 600 micrograms/die."( [Treatment of central diabetes insipidus using oral DDAVP. Comparison with intranasal treatment].
Bernareggi, V; Carraro, A; Fano, M; Giusti, M; Porcella, E,
)
0.13
" After frusemide there was a small transient increase in excretion of active kallikrein 1-2 h after dosing which coincided with the maximum diuresis and natriuresis."( Active and inactive urinary kallikrein in man: effects of diuresis and antidiuresis.
Albano, JD; Bhatia, SS; Campbell, SK; Millar, JG; Waller, DG, 1990
)
0.28
" Long-term follow-up studies did not disclose any recurrence of the pituitary granulomatous process nor objective evidence of underlying disease even after steroid dosage has been tapered."( Pituitary granuloma and pyoderma gangrenosum.
Chanson, P; Derome, PJ; Guillausseau, PJ; Kujas, M; Lubetzki, J; Timsit, J; Violante, A; Warnet, A, 1990
)
0.28
"Although several studies have demonstrated the efficacy of the vasopressin analog DDAVP in enhancing human memory, no previous study has reported the dose-response relationship of DDAVP to memory in healthy young adults."( Dose-dependent effects of DDAVP on memory in healthy young adult males: a preliminary study.
Beckwith, BE; Poland, RE; Reno, CR; Till, RE,
)
0.13
" In all cases, the dose-response curves were linear and the slopes of the regression lines were essentially the same."( New variant of von Willebrand disease with defective binding to factor VIII.
Fressinaud, E; Girma, JP; Meyer, D; Nishino, M; Rothschild, C, 1989
)
0.28
" IAP pretreatment also caused a marked upward shift in the dose-response curve of vasopressin (10(-10) to 10(-4) M)-induced cAMP accumulation."( Tonic inhibition of renal response to vasopressin by a pertussis toxin substrate.
Fallet, R; Gong, GD; Jeffries, WB; Pettinger, WA; Van Dreal, P, 1988
)
0.27
" At the DDAVP dosage used in this study and currently recommended for therapy, the VIII:C response is neither a function of the rate of absorption of the compound nor of the magnitude of its plasma concentration."( Intravenous and subcutaneous administration of desmopressin (DDAVP) to hemophiliacs: pharmacokinetics and factor VIII responses.
Alberca, I; Harris, AS; Lindquist, A; Longo, G; Mannucci, PM; Sacchi, E; Vicente, V, 1987
)
0.27
" Calculation of the ED50 data from dose-response curves of both peptides show that AVP is about 10(4)-fold more active than OXT in inhibiting in vitro progesterone and androstenedione secretion."( Inhibitory effect of oxytocin and vasopressin on steroid release by cultured porcine luteal cells.
Jarry, H; Pitzel, L; Probst, I; Wuttke, W, 1988
)
0.27
"The effect of methylcellulose on the particle size distribution and dosing accuracy of pre-metered spray pump devices containing the peptide desmopressin (DDAVP) was investigated."( Effect of viscosity on particle size, deposition, and clearance of nasal delivery systems containing desmopressin.
Harris, AS; Lethagen, S; Nilsson, IM; Svensson, E; Wagner, ZG, 1988
)
0.27
"The dose-response relationships and pharmacokinetics of orally administered 1-desamino-8-D-AVP (DDAVP) were investigated."( Antidiuretic effect and pharmacokinetics of oral 1-desamino-8-D-arginine vasopressin. 1. Studies in adults and children.
Dunger, DB; Lewis, RJ; Lightman, SL; Lyon, CC; Taylor, F; Williams, TD, 1986
)
0.27
" Patients were discharged from hospital on a preliminary dosage regimen ranging from 100 to 400 mcg three times daily."( Oral desmopressin in central diabetes insipidus.
Harris, AS; Westgren, U; Wittström, C, 1986
)
0.27
" A dose-response study in five of the patients indicated that peroral DDAVP doses as small as 10 micrograms have effects on renal concentrating ability."( Peroral treatment of diabetes insipidus with a polypeptide hormone analog, desmopressin.
Hammer, M; Vilhardt, H, 1985
)
0.27
" Further studies may be valuable, possibly relating dosage to body weight."( DDAVP in young enuretic patients: a double-blind trial.
Ferrie, BG; Glen, ES; MacFarlane, J, 1984
)
0.27
" DDAVP up to 10(-5) mol/l had no effect but shifted the dose-response curves of AVP to the right."( DDAVP (1-desamino-8-D-arginine vasopressin): an antagonist of the pressor action of endogenous vasopressin?
Derkx, FH; Jones, R; Man in 't Veld, AJ; Reid, JL; Schalekamp, MA, 1983
)
0.27
" Data processing consists of mathematical representation of two curved dose-response surfaces followed by solution of this pair of nonlinear simultaneous equations for the unknown arginine vasopressin and desmopressin concentrations."( A bivariate radioimmunoassay for arginine vasopressin and the synthetic antidiuretic agent 1-deamino-8-D-arginine vasopressin (desmopressin).
Dawson, KP; Lynskey, CP; Sadler, WA, 1984
)
0.27
" With 2 h CS-US delay the same dosage of the peptide caused CTA impairment, manifested by weaker and faster decaying aversion to saccharin."( Specificity of the effect of desglycinamide (8-D-arginine) deaminovasopressin on short--term memory.
Bures, J; Buresová, O; Skopková, J, 1983
)
0.27
" Nevertheless, the antinociceptive action of vasopressin does not appear to be secondary to its pressor activity, since phenylephrine failed to induce an antinociceptive effect at a dosage that mimicked the pressor response to vasopressin."( Vasopressin-induced antinociception: an investigation into its physiological and hormonal basis.
Berntson, GG; Berson, BS; Kirk, WT; Torello, MW; Zipf, W, 1983
)
0.27
" The duration of the action of sublingually administered DDAVP was 12 hrs; after dosing DVDAVP the effect lasted even 6 hrs."( Effects of vasopressin analogues (DDAVP, DVDAVP) in the form of sublingual tablets in central diabetes insipidus.
Julesz, J; Laczi, F; Lázló, FA; Mezei, G, 1981
)
0.26
" [4-Threonine, 7-glycine]oxytocin, a highly potent and selective uterotonic oxytocin analogue, had no detectable prostaglandin-releasing activity at a dosage 30 times higher than oxytocin."( Agonist and antagonist specificities of decidual prostaglandin-releasing oxytocin receptors and myometrial uterotonic oxytocin receptors in pregnant rats.
Chan, WY; Chen, DL; Manning, M, 1994
)
0.29
" The effect did not correlate with a dosage strictly based on body weight."( Abnormalities of water metabolism in children and adolescents following craniotomy for a brain tumor.
Blumberg, DL; David, R; Sklar, CA; Wisoff, J, 1994
)
0.29
"To find the optimal dosage of desmopressin tablets and to compare desmopressin's efficacy with placebo in a group of adolescents with severe monosymptomatic enuresis."( Desmopressin tablets in the treatment of severe nocturnal enuresis in adolescents.
Läckgren, G; Stenberg, A, 1994
)
0.29
" We reviewed all randomized controlled trials to determine (1) short- and long-term efficacy, (2) responders, (3) dose-response curve, (4) side effects, and (5) comparative efficacy with other treatments."( Desmopressin acetate and nocturnal enuresis: how much do we know?
Burd, L; Harlos, S; Kirshen, AJ; Moffatt, ME, 1993
)
0.29
" Five studies attempted to address the dose-response issue."( Desmopressin acetate and nocturnal enuresis: how much do we know?
Burd, L; Harlos, S; Kirshen, AJ; Moffatt, ME, 1993
)
0.29
" The drugs were: AVT, V1-agonist ([Phe2 Orn8]VT), and V2-agonist (DDAVP), in dosage of 50 pmol/kg*min each."( At low dose, arginine vasotocin has vasopressor rather than vasodepressor effect in chickens.
Koike, TI; Marks, PA; Robinzon, B, 1993
)
0.29
") and oral administration of ronidazole in sheep (n = 6) at a dosage of 5 mg/kg body weight."( Plasma ronidazole concentrations in sheep after intravenous, oral, intraruminal and intraabomasal administration.
Debackere, M; Vynckier, LJ, 1993
)
0.29
" Despite the sodium restriction, amiloride had no effect on FELi, although the dosage was sufficient to cause a 6-fold increase in sodium excretion, and potassium retention."( Indomethacin- and desamino-8-D-arginine vasopressin-induced lithium reabsorption is not amiloride sensitive in humans.
Bijlsma, JA; Boer, WH; Dorhout Mees, EJ; Koomans, HA; van Rijn, HJ, 1993
)
0.29
" The dosage used is 25-40 U factor VIII/IX per kilogram bodyweight given three times or twice weekly, respectively."( The treatment of haemophilia, including prophylaxis, constant infusion and DDAVP.
Berntorp, E, 1996
)
0.29
" After treatment with either dosage of DDAVP the subjects generally tolerated the pressure on their index finger for a longer time than after placebo treatment."( Modulation of pain perception in man by a vasopressin analogue.
Arnold, H; Fehm-Wolfsdorf, G; Pause, BM; Pohl, J; Schulte, HM; Schulz, A, 1996
)
0.29
" This effect was demonstrated graphically as a bell-shaped dose-response curve with a peak response at doses of 3 x 10(-8) and 3 x 10(-6) mg."( Population profile of brain asymmetry in rats after intra-amniotic administration of vasopressin.
Chebotar, NA; Ignat'eva, TV; Klement'ev, BI; Konopistseva, LA,
)
0.13
" An adjustment in dosage was necessary in seven patients during follow-up, resulting in a final dose of 600 micrograms d-1."( Oral desmopressin treatment of central diabetes insipidus in children.
Bergadá, C; Boulgourdjian, EM; Heinrich, JJ; Martínez, AS; Ropelato, MG, 1997
)
0.3
"The aim of this study was to characterize the magnitude and duration of the antidiuretic effects elicited by desmopressin given in hemostatic dosage intravenously (i."( Antidiuretic effect of desmopressin given in hemostatic dosages to healthy volunteers.
Frick, K; Lethagen, S; Sterner, G, 1998
)
0.3
" If the reduction of at least the 50% of the basal number of the wet nights is not achieved, the dosage must be increased until 40 micrograms."( [An update on clinical and therapeutic aspects of nocturnal enuresis].
Chiozza, ML,
)
0.13
"To determine the time taken to achieve complete dryness, the management of desmopressin dosage to reduce the relapse rate, the mean dosage in those responding and any side effects of long-term treatment."( Long-term use and tapered dose reduction of intranasal desmopressin in the treatment of enuretic children.
Glauninger, P; Oswald, J; Riccabona, M, 1998
)
0.3
" The maximum dosage was maintained for at least 4-6 weeks."( Long-term use and tapered dose reduction of intranasal desmopressin in the treatment of enuretic children.
Glauninger, P; Oswald, J; Riccabona, M, 1998
)
0.3
" The dosage of desmopressin (group A, n = 31 ) was 20 microg/day and the dosage of indomethacin (group B, n = 29) was 100 mg/day."( Desmopressin versus indomethacin treatment in primary nocturnal enuresis and the role of prostaglandins.
Hasanoğlu, E; Sener, F; Söylemezoğlu, O, 1998
)
0.3
" Mean nasal dosage was found to be 20."( [Treatment of diabetes insipidus with Minirin. Switch from nasal to oral administration].
Czernichow, P, 1998
)
0.3
"While certain plasma-derived factor VIII/von Willebrand factor (FVIII/vWF) concentrates have proven to be quite useful in preventing or controlling bleeding in persons with von Willebrand disease who are not candidates for DDAVP, most of the information concerning dosage and effectiveness has been anecdotal."( Clinical guidelines for treating von Willebrand disease patients who are not candidates for DDAVP--a survey of European physicians.
Lusher, JM, 1998
)
0.3
" On each study day, blood was sampled up to 8 h after dosing for assessment of desmopressin concentration."( Changes in gastrointestinal motility influence the absorption of desmopressin.
Bengtsson, P; Callréus, T; Höglund, P; Lundahl, J, 1999
)
0.3
" This paper is a review of the haemostatic use of desmopressin with special reference to women's bleeding disorders, the mechanisms of action, modes of administration, clinical indications, dosage recommendations, and hospital or home treatment."( Desmopressin in the treatment of women's bleeding disorders.
Lethagen, S, 1999
)
0.3
" We report 19 patients who have used the drug for an average of 2 years and 4 months, 18 of whom confirmed continued dramatic benefit without any obvious change in dosage used or efficacy and with few side effects."( Long term use of desmopressin for urinary symptoms in multiple sclerosis.
Addison, R; Schon, F; Tubridy, N, 1999
)
0.3
" This is the first report of symptomatic hyponatraemia in an adult patient with recommended dosing of Stimate."( Adverse events during use of intranasal desmopressin acetate for haemophilia A and von Willebrand disease: a case report and review of 40 patients.
Abshire, TC; Dunn, AL; Powers, JR; Ribeiro, MJ; Rickles, FR, 2000
)
0.31
" The dosage of the coagulation products and the duration of therapy depend on many variables, including the severity of the hemorrhage, the pharmacokinetics of the coagulation products, and patient-specific factors."( Coagulation products and their uses.
Lindley, CM; Shord, SS, 2000
)
0.31
" Changes in IOP and pupil size were monitored for up to 6 hours and dose-response curves were generated."( Exogenous vasopressin influences intraocular pressure via the V(1) receptors.
Costa, VP; Gondim, EL; Liu, JH; Weinreb, RN, 2001
)
0.31
" Physical and biochemical barriers, lack of optimal dosage forms and delivery devices limit the systemic delivery of biotherapeutic agents by inhalation."( The lung as a route for systemic delivery of therapeutic proteins and peptides.
Agu, RU; Armand, M; Kinget, R; Ugwoke, MI; Verbeke, N, 2001
)
0.31
" A linear dose-response relationship was observed (p <0."( The efficacy and safety of oral desmopressin in children with primary nocturnal enuresis.
Salzman, PM; Schulman, SL; Stokes, A, 2001
)
0.31
"In the present prospective study including 43 children therapeutic success was therefore evaluated on the basis of the dosage that was standardized according to both age and weight of the patients."( [Age- and weight-related dosage of dDAVP in the treatment of primary nocturnal enuresis].
Chavez-Kattau, K; Eggert, P; Müller, D,
)
0.13
"The results suggest an ideal weight-related dosage of 1 microgram x weight or rather an age- and weight-related dosage of 8 microgram x weight/age."( [Age- and weight-related dosage of dDAVP in the treatment of primary nocturnal enuresis].
Chavez-Kattau, K; Eggert, P; Müller, D,
)
0.13
" In general, these alternatives are safe with proper dosing and monitoring of effects."( Safety and efficacy of methods for reducing perioperative allogeneic transfusion: a critical review of the literature.
Wells, PS,
)
0.13
" Study group 1 (10 healthy volunteers) received a DDAVP infusion to establish dose-response curves for the in vitro inhibition of platelet function by eptifibatide, abciximab, and tirofiban together with l-aspirin before and after DDAVP."( Desmopressin antagonizes the in vitro platelet dysfunction induced by GPIIb/IIIa inhibitors and aspirin.
Blazicek, H; Domanovits, H; Galehr, E; Jilma, B; Jilma-Stohlawetz, P; Mayr, F; Reiter, RA, 2003
)
0.32
"In this study, minitablet and granule formulations were developed as solid oral dosage forms for the delivery of peptide drugs with the absorption enhancer N-trimethyl chitosan chloride (TMC)."( N-trimethyl chitosan chloride as absorption enhancer in oral peptide drug delivery. Development and characterization of minitablet and granule formulations.
Junginger, HE; Kotzé, AF; van der Merwe, SM; Verhoef, JC, 2004
)
0.32
"Although desmopressin appears to be safe and well-tolerated by patients with impaired renal function, great caution should be exercised when titrating towards an efficient dosage regimen if patients with moderately or severely impaired renal function are to be treated with desmopressin at all."( Pharmacokinetics and renal excretion of desmopressin after intravenous administration to healthy subjects and renally impaired patients.
Agersø, H; Karlsson, MO; Lövgren, U; Riis, A; Seiding Larsen, L; Senderovitz, T, 2004
)
0.32
" Plasma desmopressin at 2 h after dosing cannot be used to predict the pharmacodynamic response, although desmopressin lowers the nocturnal diuresis and the number of nocturnal voids."( The pharmacokinetics of 400 microg of oral desmopressin in elderly patients with nocturia, and the correlation between the absorption of desmopressin and clinical effect.
Djurhuus, JC; Hvistendahl, GM; Nørgaard, JP; Riis, A, 2005
)
0.33
" The therapeutic regimen provided for a maximum dose of desmopressin of 40 microg/day (four puffs/nostril or two tablets), starting from an initial dosage of 20 microg/day (two puffs/nostril or one tablet) 1 h before going to bed."( Desmopressin is a safe drug for the treatment of enuresis.
Auriemma, R; Cennamo, M; Del Gado, G; Del Gado, R; Del Gaizo, D; Vernì, M, 2005
)
0.33
" An overhydration technique was used before dosing to suppress endogenous vasopressin production and thereby ensure that any antidiuresis could be attributed to treatment."( A new fast-melting oral formulation of desmopressin: a pharmacodynamic study in children with primary nocturnal enuresis.
Bogaert, GA; Deboe, V; Hoebeke, P; Mattsson, S; Norgaard, JP; Schurmans, T; Vande Walle, JG, 2006
)
0.33
" Dosage and timing of VWF/FVIII administrations should be planned to keep FVIII level between 50 and 150 U/dL."( Von Willebrand's disease: clinical management.
Berntorp, E; Castaman, G; Federici, AB; Thompson, A, 2006
)
0.33
" More studies using clinically significant endpoints are necessary to assess the relative efficacy and optimal dosing of these drugs."( Pharmacological approaches to reducing blood loss and transfusions in the surgical patient.
Ozier, Y; Schlumberger, S, 2006
)
0.33
" Dosage and timing of VWF/FVIII administrations should be planned to keep the FVIII level between 50 and 150 IU/dL."( Management of inherited von Willebrand disease in 2006.
Federici, AB, 2006
)
0.33
" Because the bleeding tendency is moderate in type 2 and severe in type 3 vWD, and because the FVIII:C levels are subnormal in type 2 and very low in type 3 vWD patients, new guidelines using vWF:RCo unit dosing for the prophylaxis and treatment of bleeding episodes are proposed."( Guidelines for the evaluation of intravenous desmopressin and von Willebrand factor/factor VIII concentrate in the treatment and prophylaxis of bleedings in von Willebrand disease types 1, 2, and 3.
Berneman, Z; Gadisseur, A; Michiels, JJ; Schroyens, W; van de Velden, A; van der Planken, M, 2006
)
0.33
" After in-patient dosage titration, outpatients' serum sodium concentrations were maintained in a narrower range in the sc group compared with the intranasal group, and the percentage of serum sodium concentrations within the normal range was greater in the sc group."( Use of subcutaneous DDAVP in infants with central diabetes insipidus.
Aijaz, N; Blanco, EJ; Blumberg, D; Lane, AH; Wilson, TA, 2006
)
0.33
" The dosage selected for the study was based on the established dose of commercially available desmopressin nasal spray (20 mug before bedtime) and on clinical trial experience."( Maximal bladder capacity is a positive predictor of response to desmopressin treatment in patients with MS and nocturia.
Karagiannis, G; Karamouti, M; Papaioannou, P; Zahariou, A, 2008
)
0.35
" Desmopressin MELT had similar levels of efficacy and safety at lower dosing levels than the tablet, and therefore facilitates early initiation of PNE treatment in children aged 5-6 years."( A randomised comparison of oral desmopressin lyophilisate (MELT) and tablet formulations in children and adolescents with primary nocturnal enuresis.
Alloussi, S; El-Radhi, AS; Froeling, F; Lottmann, H; Persson, BE; Riis, A; Rittig, S, 2007
)
0.34
" While a large body of clinical data is available for desmopressin, and despite its widespread use, comprehensive reviews of the safety of desmopressin are lacking (although some case series have attempted to correlate patient and/or dosing characteristics with the occurrence of adverse reactions)."( Desmopressin 30 years in clinical use: a safety review.
Nørgaard, JP; Raes, A; Stockner, M; Vande Walle, J, 2007
)
0.34
"Only patients with primary nocturnal enuresis refractory to the maximal dosage of desmopressin were enrolled."( Combination therapy with desmopressin and an anticholinergic medication for nonresponders to desmopressin for monosymptomatic nocturnal enuresis: a randomized, double-blind, placebo-controlled trial.
Austin, PF; Campigotto, MJ; Coplen, DE; Ferguson, G; Royer, ME; Yan, Y, 2008
)
0.35
" Compliance and dosage were also associated with response and more patients experienced > or = 50% reduction in wet nights after 6 months' treatment than earlier in the study, suggesting the value of persistent treatment."( Long-term desmopressin response in primary nocturnal enuresis: open-label, multinational study.
Baydala, L; Eggert, P; Evans, J; Klein, BM; Lottmann, H; Norgaard, JP, 2009
)
0.35
"To create improved pharmaceutical formulations for nasal and sublingual administration of desmopressin and investigate their pharmacokinetic profiles in comparison with a commercial nasal liquid spray and finally to evaluate the volunteers' opinions on the different dosage forms."( Clinical study shows improved absorption of desmopressin with novel formulation.
Björk, E; Bredenberg, S; Fransén, N, 2009
)
0.35
"The nasal powder formulation is a promising new dosage form for the delivery of desmopressin and other compounds."( Clinical study shows improved absorption of desmopressin with novel formulation.
Björk, E; Bredenberg, S; Fransén, N, 2009
)
0.35
" As the bleeding tendency is moderate in VWD type 2 and severe in type 3 and because the FVIII:C levels are subnormal in type 2 but very low in type 3 VWD patients, new guidelines using VWF:RCo unit dosing for the acute and prophylactic treatment of bleeding episodes are proposed."( Managing patients with von Willebrand disease type 1, 2 and 3 with desmopressin and von Willebrand factor-factor VIII concentrate in surgical settings.
Berneman, Z; Gadisseur, A; Michiels, JJ; Schroyens, W; van Vliet, HH, 2009
)
0.35
" A dose-response profile revealed a noncompetitive property of VRQ397; correspondingly, VRQ397 bound specifically to V2R-expressing cells could not displace its natural ligand, AVP, but modulated AVP binding kinetics (dissociation rate)."( VRQ397 (CRAVKY): a novel noncompetitive V2 receptor antagonist.
Beauregard, K; Bouvier, M; Brault, S; Chemtob, S; Duhamel, F; Gobeil, F; Guillon, G; Hamdan, FF; Hamel, D; Hardy, P; Heveker, N; Hou, X; Joyal, JS; Kaul, R; Lahaie, I; Lubell, WD; Nedev, H; Quiniou, C; Rihakova, L; Sapieha, P; Saragovi, HU; Shao, Z, 2009
)
0.35
" Dosing has traditionally been calculated based on the FVIII content of the products, although dosing based on VWF functional activity [e."( Von Willebrand factor/factor VIII concentrates in the treatment of von Willebrand disease.
Batlle, J; Fraga, EL; López-Fernández, MF; Pérez-Rodríguez, MA; Trillo, AR, 2009
)
0.35
" All 21 patients with DI required daily change in dosage and schedule of DDAVP."( Challenges in management of patients with intracranial germ cell tumor and diabetes insipidus treated with cisplatin and/or ifosfamide based chemotherapy.
Afzal, S; Bartels, U; Bouffet, E; Huang, A; Stephens, D; Tabori, U; Wherrett, D, 2010
)
0.36
" Frequency of desmopressin and antifibrinolytic dosing varied widely."( Adenotonsillectomy in patients with desmopressin responsive mild bleeding disorders: a review of the literature.
Cox Gill, J; Dunn, AL, 2010
)
0.36
" We believe that desmopressin in all formulations has a good safety profile in children with MNE, provided that treatment is properly prescribed and monitored; improving the training of doctors and patients in the dose-response kinetics of the drug, teaching appropriate restriction of fluid intake and by encouraging the use of desmopressin within a narrow dose range (10-20 microg spray, 120-240 microg melt and 200-400 microg tablet) when used in primary-care settings."( Is there still a role for desmopressin in children with primary monosymptomatic nocturnal enuresis?: a focus on safety issues.
Raes, A; Van de Walle, J; Van Herzeele, C, 2010
)
0.36
" Further studies are needed to elucidate the best compromise between dosing regimen, efficacy and safety in various clinical settings."( Pharmacological agents: antifibrinolytics and desmopressin.
Bellamy, L; Ozier, Y, 2010
)
0.36
" Dosing strategies for medications used in the ICU are typically developed for use in noncritically ill patients and, therefore, do not account for the altered pharmacokinetic and pharmacodynamic properties encountered in the critically ill as well as the increased potential for drug-drug interactions, given the far greater number of medications ordered."( Adverse drug events associated with disorders of coagulation.
Barletta, JF; Cooper, B; Ohlinger, MJ, 2010
)
0.36
" The duration of antidiuretic action was 4, 8 and 11 h, respectively, for 125, 250, and 500 ng, increasing from 250 to 500 ng but for the remaining secondary dynamic efficacy parameters no difference could be detected based on descriptive statistics between the doses 250 and 500 ng, indicating that the upper plateau region of the dose-response curve had been reached."( Desmopressin duration of antidiuretic action in patients with central diabetes insipidus.
Bichet, DG; Juul, KV; Nørgaard, JP, 2011
)
0.37
" Reductions in serum sodium to <125 mmol/L in six women (taking >25 µg desmopressin) and two men (aged 67 and 82) taking 100 µg, support lower and gender-specific dosing to reduce the small but clinically significant risk of hyponatraemia."( Desmopressin orally disintegrating tablet effectively reduces nocturia: results of a randomized, double-blind, placebo-controlled trial.
Klein, BM; Nørgaard, JP; Weiss, JP; Zinner, NR, 2012
)
0.38
"Fluid deprivation tests were performed without (d0) and after one (d1) and five days (d5) of oral prednisolone (Pred) pretreatment in a dosage relevant to drug therapy (30 mg/day)."( Arginine vasopressin-dependent and AVP-independent mechanisms of renal fluid absorption during thirsting despite glucocorticoid-mediated vasopressin suppression.
Bähr, V; Diederich, S; Mai, K; Pedersen, EB; Pfeiffer, AF; Spranger, J; Ufer, F, 2013
)
0.39
" Desmopressin (DDAVP) and antifibrinolytics are the mainstays of treatment in these patients, yet the optimal dosing and timing of these agents to prevent or resolve bleeding, while minimizing adverse side effects, is sometimes unclear."( Common management issues in pediatric patients with mild bleeding disorders.
O'Brien, SH, 2012
)
0.38
"To establish the dose-response efficacy of desmopressin in a Japanese patient population for the treatment of nocturia."( Gender difference in efficacy and dose response in Japanese patients with nocturia treated with four different doses of desmopressin orally disintegrating tablet in a randomized, placebo-controlled trial.
Juul, KV; Nishizawa, O; Nørgaard, JP; Yamaguchi, O, 2013
)
0.39
" The dose-response relationship of pharmacodynamic variables measured after a single dose of desmopressin administered to water-loaded subjects (treatment period 1) was compared with the primary clinical endpoint of change from baseline in mean number of nocturnal voids, after 28 days of desmopressin treatment (treatment period 2)."( Gender difference in efficacy and dose response in Japanese patients with nocturia treated with four different doses of desmopressin orally disintegrating tablet in a randomized, placebo-controlled trial.
Juul, KV; Nishizawa, O; Nørgaard, JP; Yamaguchi, O, 2013
)
0.39
" In treatment period 1 a dose-response relationship was observed, both overall and in each gender group."( Gender difference in efficacy and dose response in Japanese patients with nocturia treated with four different doses of desmopressin orally disintegrating tablet in a randomized, placebo-controlled trial.
Juul, KV; Nishizawa, O; Nørgaard, JP; Yamaguchi, O, 2013
)
0.39
"A dose-response relationship for desmopressin ODT was shown in a population of Japanese patients with nocturia."( Gender difference in efficacy and dose response in Japanese patients with nocturia treated with four different doses of desmopressin orally disintegrating tablet in a randomized, placebo-controlled trial.
Juul, KV; Nishizawa, O; Nørgaard, JP; Yamaguchi, O, 2013
)
0.39
" However, owing to the agglomerate larger size, powder flowability was greatly improved in comparison with the original microparticles, allowing accurate powder dosing into the nasal delivery device."( Antidiuretic effect of desmopressin chimera agglomerates by nasal administration in rats.
Balducci, AG; Bortolotti, F; Colombo, G; Colombo, P; Ferraro, L; Nastruzzi, C; Russo, P; Sonvico, F, 2013
)
0.39
" Dosage should be adjusted according to FVIII levels in plasma."( Haemostatic treatment in connection with surgery in patients with von Willebrand disease.
Lethagen, S, 1999
)
0.3
"64 years), were treated with MELT at a dosage of 120 mcg a day."( Oral desmopressin lyophilisate (MELT) for monosymptomatic enuresis: structured versus abrupt withdrawal.
Chiaretti, A; Cortina, I; Fabrizio, GC; Ferrara, P; Ianniello, F; Romano, V, 2014
)
0.4
" There is wide inter-individual variation in dose requirement and dosing intervals."( Desmopressin administration in children with central diabetes insipidus: a retrospective review.
Ambler, GR; Maguire, AM; Ooi, HL, 2013
)
0.39
" The dosage for desmopressin oral lyophilisate is more predictable due to the significantly smaller variance."( Pharmacokinetics of desmopressin administered as tablet and oral lyophilisate formulation in children with monosymptomatic nocturnal enuresis.
De Bruyne, P; De Guchtenaere, A; Dehoorne, J; Hoebeke, P; Raes, A; Van Herzeele, C; Van Laecke, E; Vande Walle, J, 2014
)
0.4
" Half of the patients with CDI prescribed as oral treatment were provided dosing instructions to only administer the drug before bedtime, and one third of the CDI patients either had no specific instructions or were instructed to use the drug as needed."( National Surveillance of Central Diabetes Insipidus (CDI) in Denmark: results from 5 years registration of 9309 prescriptions of desmopressin to 1285 CDI patients.
Juul, KV; Nørgaard, JP; Rittig, S; Schroeder, M, 2014
)
0.4
"As neonatal central diabetes insipidus is rare in preterm neonates with intraventricular hemorrhage (IVH), very little is known about dosing and the route of administration of desmopressin treatment."( Transient diabetes insipidus in a preterm neonate and the challenge of desmopressin dosing.
Dudink, J; van den Akker, EL; Van der Kaay, DC; Van Heel, WJ, 2014
)
0.4
"The determination of the desmopressin dose in a preterm neonate is a challenge and there is no consistent literature about the dosing or the route of administration."( Transient diabetes insipidus in a preterm neonate and the challenge of desmopressin dosing.
Dudink, J; van den Akker, EL; Van der Kaay, DC; Van Heel, WJ, 2014
)
0.4
"3) when the subjects reached their final dosing level."( Prophylaxis escalation in severe von Willebrand disease: a prospective study from the von Willebrand Disease Prophylaxis Network.
Abshire, T; Berntorp, E; Carcao, M; Cox-Gill, J; Donfield, S; Kempton, CL; Kouides, P; Leebeek, FW, 2015
)
0.42
" The effect was less pronounced at 32 °C, with a significant reduction in EPICT obtained with a dosage of 5 microgram only (p = 0."( The effectiveness of low-dose desmopressin in improving hypothermia-induced impairment of primary haemostasis under influence of aspirin - a randomized controlled trial.
Cheung, CW; Lee, Y; Leung, SW; Ng, KF; Tsui, PY, 2015
)
0.42
" A higher dosage (5 microgram) further reduced the closure times below baseline."( The effectiveness of low-dose desmopressin in improving hypothermia-induced impairment of primary haemostasis under influence of aspirin - a randomized controlled trial.
Cheung, CW; Lee, Y; Leung, SW; Ng, KF; Tsui, PY, 2015
)
0.42
" Approximately two thirds of patients received dosing instructions to administer the drug 4 times daily to provide 24-h antidiuretic coverage."( Desmopressin as an adjuvant to opioids or NSAIDs in treatment of renal colic: a nationwide register-based study.
Juul, KV; Nørgaard, JP; Rittig, S; Schroeder, MK, 2015
)
0.42
"The higher sensitivity to desmopressin (dDAVP) found in women and older patients with nocturnal polyuria (NP) has partially been unraveled, leading to adaptation of the dosage based on gender."( Pharmacokinetics and Pharmacodynamics of the Oral Disintegrating Tablet of Desmopressin in Adults with Nocturnal Polyuria: A Pilot Study.
Everaert, K; Goessaert, AS; Hoebeke, P; Vande Walle, J, 2015
)
0.42
" The aim of this study was to investigate the dose-response effects of in vitro desmopressin in whole blood."( Desmopressin in vitro effects on platelet function, monitored with Multiplate, ROTEM and Sonoclot.
Jensen, H; Kander, T; Pearson, K; Schött, U, 2016
)
0.43
" The possibility for smaller dosage increments and ease of administration make IN DDAVP administered buccally preferable over other DDAVP treatment options in infants."( Buccally Administered Intranasal Desmopressin Acetate for the Treatment of Neurogenic Diabetes Insipidus in Infancy.
Backeljauw, P; Gutmark-Little, I; Smego, AR, 2016
)
0.43
" The fact that few patients achieved complete dryness may be due to the low dosage used."( Reboxetine in therapy-resistant enuresis: A randomized placebo-controlled study.
Hägglöf, B; Lundmark, E; Nevéus, T; Stenberg, A, 2016
)
0.43
"The incidence of hyponatraemia can be reduced by using minimum effective gender-specific dosing with the ODT formulation of desmopressin (25 μg in women, 50 μg in men)."( Low-dose desmopressin combined with serum sodium monitoring can prevent clinically significant hyponatraemia in patients treated for nocturia.
Juul, KV; Malmberg, A; Nørgaard, JP; van der Meulen, E; Walle, JV, 2017
)
0.46
" After 3 months 2/8 (25%, CI 95%: 8-65%) showed improvements, remaining 75% has been increased dosage of methylphenidate."( Attention-deficit/hyperactivity disorder and enuresis: a study about effectiveness of treatment with methylphenidate or desmopressin in a pediatric population.
Ferrara, P; Ianniello, F; Mariotti, P; Petitti, T; Quattrocchi, E; Sannicandro, V; Sbordone, A, 2019
)
0.51
" As research on new treatment strategies for established therapies, such as population pharmacokinetic-guided dosing of clotting factor concentrates, and novel treatment modalities such as aptamers and gene therapy are ongoing, it is likely that the horizon to tailor therapy to the individual patients' needs will be extended, thus, further improving the already high standard of care in VWD in most high-resource countries."( Current and Emerging Options for the Management of Inherited von Willebrand Disease.
Cnossen, MH; Heijdra, JM; Leebeek, FWG, 2017
)
0.46
"Danish national prescription data on pediatric desmopressin dosage are consistent with a greater sensitivity to desmopressin in girls than boys."( Desmopressin use in pediatric nocturnal enuresis patients: is there a sex difference in prescription patterns?
Juul, KV; Mahler, B; Nørgaard, JP; Rittig, S; Schroeder, MK, 2018
)
0.48
"The objective of this study was to describe desmopressin dosing strategies, with emphasis on hemostatic outcomes among patients without preexisting bleeding disorders."( Comparison of Two Weight-Based Desmopressin Dosing Strategies for Spontaneous Bleeding.
Franquiz, MJ; Hines, MC; Yeung, SYA, 2018
)
0.48
" More data are needed to confirm this dosing strategy."( Comparison of Two Weight-Based Desmopressin Dosing Strategies for Spontaneous Bleeding.
Franquiz, MJ; Hines, MC; Yeung, SYA, 2018
)
0.48
" Newer formulations have shown that a minimum dosage of 25 μg orally disintegrating sublingual desmopressin appears to be ideal for women, whereas men usually benefit from a minimum of 50 μg."( Desmopressin and nocturnal voiding dysfunction: Clinical evidence and safety profile in the treatment of nocturia.
Chung, E, 2018
)
0.48
" Patient demographics, DDAVP dosing and route, and outcomes such as bleeding and adverse events were collected."( Perioperative Desmopressin for Patients Undergoing Otolaryngologic Procedures: A Systematic Review.
Barinsky, GL; Buziashvili, D; Carron, MA; Eloy, JA; Folbe, AJ; Hsueh, WD; Johnson, AP; Svider, PF, 2019
)
0.51
" Both clotting factor concentrates and desmopressin are currently dosed according to the patients' body weight."( Strategies for Individualized Dosing of Clotting Factor Concentrates and Desmopressin in Hemophilia A and B.
Cnossen, MH; Kruip, MJHA; Leebeek, FWG; Mathôt, RAA; Preijers, T; Schütte, LM; van Hest, RM, 2019
)
0.51
" A recent study reported that standard dosing frequently results in FVIII levels (FVIII:C) below or above FVIII target ranges, leading to respectively a bleeding risk or excessive costs."( Desmopressin treatment combined with clotting factor VIII concentrates in patients with non-severe haemophilia A: protocol for a multicentre single-armed trial, the DAVID study.
Beckers, EAM; Cnossen, MH; Coppens, M; Driessens, MHE; Eikenboom, J; Fijnvandraat, K; Kruip, MJHA; Laros-van Gorkom, BAP; Leebeek, FWG; Mathôt, RAA; Mauser-Bunschoten, EP; Meijer, K; Nieuwenhuizen, L; Polinder, S; Schütte, LM; van Hest, RM, 2019
)
0.51
" Simulations were performed to further explore the relative bioavailability of both formulations and evaluate current dosing strategies."( An Integrated Paediatric Population PK/PD Analysis of dDAVP: How do PK Differences Translate to Clinical Outcomes?
De Bruyne, P; Dossche, L; Gasthuys, E; Michelet, R; Van Bocxlaer, J; Van Herzeele, C; Vande Walle, J; Vermeulen, A, 2020
)
0.56
" Simulations showed that current dosing regimens using a fixed dose of lyophilizate 120 μg is not adequate for children, assuming children to be in the fed state when taking dDAVP."( An Integrated Paediatric Population PK/PD Analysis of dDAVP: How do PK Differences Translate to Clinical Outcomes?
De Bruyne, P; Dossche, L; Gasthuys, E; Michelet, R; Van Bocxlaer, J; Van Herzeele, C; Vande Walle, J; Vermeulen, A, 2020
)
0.56
" A follow-up clinical trial testing the proposed dDAVP dosing regimen should be performed."( An Integrated Paediatric Population PK/PD Analysis of dDAVP: How do PK Differences Translate to Clinical Outcomes?
De Bruyne, P; Dossche, L; Gasthuys, E; Michelet, R; Van Bocxlaer, J; Van Herzeele, C; Vande Walle, J; Vermeulen, A, 2020
)
0.56
" Specialists must supervise fluid replacement and dosing of desmopressin."( ENDOCRINOLOGY IN THE TIME OF COVID-19: Management of diabetes insipidus and hyponatraemia.
Christ-Crain, M; Hoorn, EJ; Sherlock, M; Thompson, CJ; Wass, JAH, 2020
)
0.56
" If the therapeutic effect was not satisfactory dosage was adjusted and desmopressin was added."( The prognostic value of voiding chart data in therapy-resistant enuresis.
Lundmark, E; Neve Us, T, 2020
)
0.56
" Prescribing the standard flat-dose regimen to the entire pediatric population might be insufficient to attain response to desmopressin treatment, whereby dosing schemes based on age and weight were proposed."( Pediatric Pharmacology of Desmopressin in Children with Enuresis: A Comprehensive Review.
Croubels, S; Devreese, M; Dossche, L; Gasthuys, E; Michelet, R; Nørgaard, JP; Van Bocxlaer, J; Vermeulen, A; Walle, JV, 2020
)
0.56
" The dosage of desmopressin acetate varied according to the discretion of the physician, usually beginning with one tablet before going to bed at night for 3 months."( Monocentric single-arm study of desmopressin acetate efficacy on nocturnal polyuria in the elderly.
Iannitti, T; Morales-Medina, JC; Palmieri, B; Vadalà, M, 2020
)
0.56
" Studies on the rationale of dosing are scarce and mainly focus on the underlying causes of the vast differences in desmopressin response among individuals."( A Novel Quantitative Method for Analyzing Desmopressin in Human Plasma Using Liquid Chromatography-Tandem Mass Spectrometry.
Cnossen, MH; de Jager, NCB; Heijdra, JM; Kruip, MJHA; Leebeek, FWG; Mathôt, RAA; Pistorius, M, 2020
)
0.56
" Moreover, the need for size-adapted dosing regimens of dDAVP lyophilisate in young children is indicated."( Desmopressin oral lyophilisate in young children: new insights in pharmacokinetics and pharmacodynamics.
De Bruyne, P; Dossche, L; Gasthuys, E; Michelet, R; Rittig, S; Van Herzeele, C; Vande Walle, J; Vermeulen, A, 2021
)
0.62
" This model is a starting point toward more accurate prediction of desmopressin dosing effects in VWD."( Population Pharmacokinetic Modeling of von Willebrand Factor Activity in von Willebrand Disease Patients after Desmopressin Administration.
Cnossen, MH; de Jager, NCB; Heijdra, JM; Kieboom, Q; Kruip, MJHA; Leebeek, FWG; Mathôt, RAA, 2020
)
0.56
" Although there are minimal guidelines regarding the appropriate formulation and dosage of DDAVP for management of CDI in infants, we initiated the lowest dose available and titrated the medication based on close monitoring of urine output and serum sodium levels in order to successfully treat his transient CDI."( Management of transient central diabetes insipidus with intravenous desmopressin in a premature infant with gastroschisis and septo-optic dysplasia: A case report.
Kim, F; Towers, HM, 2021
)
0.62
" The spermatogenesis rate decreased with increased dosage of desmopressin."( Desmopressin Suppresses Gonadotropin-Induced Spermatogenesis in Patients With Pituitary Stalk Interruption Syndrome: A Retrospective, Single-Center Cohort Study.
Bingqing, Y; Jiangfeng, M; Min, N; Qibin, H; Rui, Z; Shuying, L; Wen, J; Xi, W; Xueyan, W; Yinjie, G, 2021
)
0.62
" Reliability and feasibility of PK-guided dosing will be tested by assessing predictive performance, treatment duration, haemostasis, patient satisfaction and physician satisfaction."( Is pharmacokinetic-guided dosing of desmopressin and von Willebrand factor-containing concentrates in individuals with von Willebrand disease or low von Willebrand factor reliable and feasible? A protocol for a multicentre, non-randomised, open label coho
Al Arashi, W; Bukkems, LH; Cloesmeijer, ME; Cnossen, MH; de Jager, NCB; Heijdra, JM; Leebeek, FWG; Mathôt, RAA; Zwaan, CM, 2022
)
0.72
" We found that paediatric data remains limited, leading to recent proposals for age- and weight-based dosing regimens."( Desmopressin therapy in children and adults: pharmacological considerations and clinical implications.
Chin, X; Han, HC; Lim, ST; Ng, YH; Teo, SW; Yap, F, 2022
)
0.72
" Subsequently, we performed Monte Carlo simulations to investigate the efficacy of the current dosing regimen."( Quantification of the relationship between desmopressin concentration and Von Willebrand factor in Von Willebrand disease type 1: A pharmacodynamic study.
Cloesmeijer, ME; Cnossen, MH; de Jager, NCB; Heijdra, JM; Kruip, MHJA; Leebeek, FWG; Mathôt, RAA, 2022
)
0.72
" Standard weight-based dosing of desmopressin was used."( Moderate-intensity aerobic exercise vs desmopressin in adolescent males with mild hemophilia A: a randomized trial.
Ahuja, S; Bouskill, V; Carcao, M; Dunn, AL; Gonzales, A; Kahr, WHA; Kerlin, BA; Kumar, R; Lillicrap, D; Pluthero, FG; Rand, ML; Schneiderman, JE; Stanek, J; Tarango, C; Waller, A; Widener, P, 2022
)
0.72
" The original dosage was then reintroduced and was still sufficient until months later."( Infection with SARS-CoV-2 may alter the half-life of desmopressin (DDAVP) in patients with central diabetes insipidus.
Bechtold-Dalla Pozza, S; Dubinski, I; Schmidt, H, 2022
)
0.72
" Individualized management and accurate hormone replacement dosage for postoperative childhood-onset CP patients are of great importance."( Postoperative hypothalamic-pituitary dysfunction and long-term hormone replacement in patients with childhood-onset craniopharyngioma.
Bai, RN; Chen, J; Deng, Y; Fan, K; Ge, M; Gong, J; Li, S; Miao, Y; Peng, X; Wei, Y; Wu, D; Wu, Q; Zhao, C, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (3)

RoleDescription
vasopressin receptor agonistAny drug which binds to vasopressin receptors and triggers a response.
renal agentA drug used for its effect on the kidneys' regulation of body fluid composition and volume.
diagnostic agentA substance administered to aid diagnosis of a disease.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (1)

ClassDescription
heterodetic cyclic peptideA heterodetic cyclic peptide is a peptide consisting only of amino-acid residues, but in which the linkages forming the ring are not solely peptide bonds; one or more is an isopeptide, disulfide, ester, or other bond.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (6)

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Vasopressin V2 receptorHomo sapiens (human)Ki0.02330.00040.43453.9811AID217394
Vasopressin V1a receptorHomo sapiens (human)Ki0.06240.00020.62357.0300AID217087
Vasopressin V1b receptorHomo sapiens (human)Ki0.00580.00050.18971.7820AID217360
Translocator proteinMus musculus (house mouse)Ki0.00030.00030.00030.0004AID277899
Vasopressin V2 receptor Rattus norvegicus (Norway rat)Ki0.00030.00030.97919.7000AID277899
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Vasopressin V2 receptorHomo sapiens (human)EC50 (µMol)0.00020.00000.55066.7000AID1178647; AID1598498
Oxytocin receptorHomo sapiens (human)EC50 (µMol)0.09100.00000.08050.8810AID1178646; AID1598499
Vasopressin V1a receptorHomo sapiens (human)EC50 (µMol)1.00000.00000.19713.2000AID1178648
Vasopressin V1b receptorHomo sapiens (human)EC50 (µMol)0.01100.00000.03600.2400AID1178649; AID1598501
Vasopressin V2 receptor Rattus norvegicus (Norway rat)EC50 (µMol)0.00000.00000.00000.0000AID1598510
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (69)

Processvia Protein(s)Taxonomy
positive regulation of systemic arterial blood pressureVasopressin V2 receptorHomo sapiens (human)
renal water retentionVasopressin V2 receptorHomo sapiens (human)
adenylate cyclase-modulating G protein-coupled receptor signaling pathwayVasopressin V2 receptorHomo sapiens (human)
activation of adenylate cyclase activityVasopressin V2 receptorHomo sapiens (human)
hemostasisVasopressin V2 receptorHomo sapiens (human)
positive regulation of cell population proliferationVasopressin V2 receptorHomo sapiens (human)
negative regulation of cell population proliferationVasopressin V2 receptorHomo sapiens (human)
positive regulation of gene expressionVasopressin V2 receptorHomo sapiens (human)
telencephalon developmentVasopressin V2 receptorHomo sapiens (human)
response to cytokineVasopressin V2 receptorHomo sapiens (human)
positive regulation of intracellular signal transductionVasopressin V2 receptorHomo sapiens (human)
cellular response to hormone stimulusVasopressin V2 receptorHomo sapiens (human)
positive regulation of vasoconstrictionVasopressin V2 receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayVasopressin V2 receptorHomo sapiens (human)
regulation of systemic arterial blood pressure by vasopressinVasopressin V2 receptorHomo sapiens (human)
suckling behaviorOxytocin receptorHomo sapiens (human)
response to amphetamineOxytocin receptorHomo sapiens (human)
muscle contractionOxytocin receptorHomo sapiens (human)
cell surface receptor signaling pathwayOxytocin receptorHomo sapiens (human)
positive regulation of cytosolic calcium ion concentrationOxytocin receptorHomo sapiens (human)
heart developmentOxytocin receptorHomo sapiens (human)
lactationOxytocin receptorHomo sapiens (human)
memoryOxytocin receptorHomo sapiens (human)
response to xenobiotic stimulusOxytocin receptorHomo sapiens (human)
positive regulation of norepinephrine secretionOxytocin receptorHomo sapiens (human)
telencephalon developmentOxytocin receptorHomo sapiens (human)
positive regulation of synaptic transmission, GABAergicOxytocin receptorHomo sapiens (human)
response to estradiolOxytocin receptorHomo sapiens (human)
response to progesteroneOxytocin receptorHomo sapiens (human)
response to anoxiaOxytocin receptorHomo sapiens (human)
response to cytokineOxytocin receptorHomo sapiens (human)
social behaviorOxytocin receptorHomo sapiens (human)
response to cocaineOxytocin receptorHomo sapiens (human)
maternal behaviorOxytocin receptorHomo sapiens (human)
sperm ejaculationOxytocin receptorHomo sapiens (human)
eating behaviorOxytocin receptorHomo sapiens (human)
response to peptide hormoneOxytocin receptorHomo sapiens (human)
estrous cycleOxytocin receptorHomo sapiens (human)
positive regulation of blood pressureOxytocin receptorHomo sapiens (human)
digestive tract developmentOxytocin receptorHomo sapiens (human)
positive regulation of synapse assemblyOxytocin receptorHomo sapiens (human)
positive regulation of synaptic transmission, glutamatergicOxytocin receptorHomo sapiens (human)
positive regulation of penile erectionOxytocin receptorHomo sapiens (human)
ERK1 and ERK2 cascadeOxytocin receptorHomo sapiens (human)
positive regulation of uterine smooth muscle contractionOxytocin receptorHomo sapiens (human)
positive regulation of cold-induced thermogenesisOxytocin receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayOxytocin receptorHomo sapiens (human)
female pregnancyOxytocin receptorHomo sapiens (human)
regulation of systemic arterial blood pressure by vasopressinOxytocin receptorHomo sapiens (human)
positive regulation of vasoconstrictionOxytocin receptorHomo sapiens (human)
maternal process involved in parturitionOxytocin receptorHomo sapiens (human)
cellular response to hormone stimulusOxytocin receptorHomo sapiens (human)
maternal aggressive behaviorVasopressin V1a receptorHomo sapiens (human)
positive regulation of systemic arterial blood pressureVasopressin V1a receptorHomo sapiens (human)
generation of precursor metabolites and energyVasopressin V1a receptorHomo sapiens (human)
activation of phospholipase C activityVasopressin V1a receptorHomo sapiens (human)
positive regulation of cytosolic calcium ion concentrationVasopressin V1a receptorHomo sapiens (human)
negative regulation of female receptivityVasopressin V1a receptorHomo sapiens (human)
grooming behaviorVasopressin V1a receptorHomo sapiens (human)
blood circulationVasopressin V1a receptorHomo sapiens (human)
positive regulation of cell population proliferationVasopressin V1a receptorHomo sapiens (human)
positive regulation of heart rateVasopressin V1a receptorHomo sapiens (human)
positive regulation of glutamate secretionVasopressin V1a receptorHomo sapiens (human)
myotube differentiationVasopressin V1a receptorHomo sapiens (human)
calcium-mediated signalingVasopressin V1a receptorHomo sapiens (human)
telencephalon developmentVasopressin V1a receptorHomo sapiens (human)
positive regulation of cell growthVasopressin V1a receptorHomo sapiens (human)
positive regulation of prostaglandin biosynthetic processVasopressin V1a receptorHomo sapiens (human)
positive regulation of cellular pH reductionVasopressin V1a receptorHomo sapiens (human)
social behaviorVasopressin V1a receptorHomo sapiens (human)
cellular response to water deprivationVasopressin V1a receptorHomo sapiens (human)
maternal behaviorVasopressin V1a receptorHomo sapiens (human)
sperm ejaculationVasopressin V1a receptorHomo sapiens (human)
response to corticosteroneVasopressin V1a receptorHomo sapiens (human)
negative regulation of transmission of nerve impulseVasopressin V1a receptorHomo sapiens (human)
transport across blood-brain barrierVasopressin V1a receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayVasopressin V1a receptorHomo sapiens (human)
positive regulation of vasoconstrictionVasopressin V1a receptorHomo sapiens (human)
cellular response to hormone stimulusVasopressin V1a receptorHomo sapiens (human)
regulation of systemic arterial blood pressure by vasopressinVasopressin V1a receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayVasopressin V1b receptorHomo sapiens (human)
activation of phospholipase C activityVasopressin V1b receptorHomo sapiens (human)
positive regulation of cytosolic calcium ion concentrationVasopressin V1b receptorHomo sapiens (human)
positive regulation of phospholipase A2 activityVasopressin V1b receptorHomo sapiens (human)
regulation of cell population proliferationVasopressin V1b receptorHomo sapiens (human)
positive regulation of MAPK cascadeVasopressin V1b receptorHomo sapiens (human)
symbiont entry into host cellVasopressin V1b receptorHomo sapiens (human)
positive regulation of inositol phosphate biosynthetic processVasopressin V1b receptorHomo sapiens (human)
positive regulation of arachidonic acid secretionVasopressin V1b receptorHomo sapiens (human)
transport across blood-brain barrierVasopressin V1b receptorHomo sapiens (human)
cellular response to hormone stimulusVasopressin V1b receptorHomo sapiens (human)
regulation of systemic arterial blood pressure by vasopressinVasopressin V1b receptorHomo sapiens (human)
positive regulation of vasoconstrictionVasopressin V1b receptorHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (7)

Processvia Protein(s)Taxonomy
vasopressin receptor activityVasopressin V2 receptorHomo sapiens (human)
protein bindingVasopressin V2 receptorHomo sapiens (human)
peptide bindingVasopressin V2 receptorHomo sapiens (human)
peptide hormone bindingOxytocin receptorHomo sapiens (human)
peptide bindingOxytocin receptorHomo sapiens (human)
vasopressin receptor activityOxytocin receptorHomo sapiens (human)
oxytocin receptor activityOxytocin receptorHomo sapiens (human)
vasopressin receptor activityVasopressin V1a receptorHomo sapiens (human)
protein kinase C bindingVasopressin V1a receptorHomo sapiens (human)
protein bindingVasopressin V1a receptorHomo sapiens (human)
peptide hormone bindingVasopressin V1a receptorHomo sapiens (human)
V1A vasopressin receptor bindingVasopressin V1a receptorHomo sapiens (human)
peptide bindingVasopressin V1a receptorHomo sapiens (human)
vasopressin receptor activityVasopressin V1b receptorHomo sapiens (human)
protein kinase C bindingVasopressin V1b receptorHomo sapiens (human)
peptide bindingVasopressin V1b receptorHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (11)

Processvia Protein(s)Taxonomy
endosomeVasopressin V2 receptorHomo sapiens (human)
endoplasmic reticulumVasopressin V2 receptorHomo sapiens (human)
Golgi apparatusVasopressin V2 receptorHomo sapiens (human)
plasma membraneVasopressin V2 receptorHomo sapiens (human)
membraneVasopressin V2 receptorHomo sapiens (human)
endocytic vesicleVasopressin V2 receptorHomo sapiens (human)
clathrin-coated endocytic vesicle membraneVasopressin V2 receptorHomo sapiens (human)
perinuclear region of cytoplasmVasopressin V2 receptorHomo sapiens (human)
plasma membraneVasopressin V2 receptorHomo sapiens (human)
plasma membraneOxytocin receptorHomo sapiens (human)
microvillusOxytocin receptorHomo sapiens (human)
adherens junctionOxytocin receptorHomo sapiens (human)
apical plasma membraneOxytocin receptorHomo sapiens (human)
plasma membraneOxytocin receptorHomo sapiens (human)
endosomeVasopressin V1a receptorHomo sapiens (human)
plasma membraneVasopressin V1a receptorHomo sapiens (human)
endocytic vesicleVasopressin V1a receptorHomo sapiens (human)
plasma membraneVasopressin V1a receptorHomo sapiens (human)
endosomeVasopressin V1b receptorHomo sapiens (human)
Golgi apparatusVasopressin V1b receptorHomo sapiens (human)
plasma membraneVasopressin V1b receptorHomo sapiens (human)
plasma membraneVasopressin V1b receptorHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (81)

Assay IDTitleYearJournalArticle
AID1598503Selectivity ratio of EC50 for human OTR stably expressed in CHOK1 cells to EC50 for recombinant human V2 receptor expressed in HEK293 cells
AID235493Selectivity index of human V1b receptor towards V1a receptor2004Journal of medicinal chemistry, Apr-22, Volume: 47, Issue:9
Design of potent and selective agonists for the human vasopressin V1b receptor based on modifications of [deamino-cys1]arginine vasopressin at position 4.
AID1598519Antidiuretic activity in hydrated-euvolemic Sprague-Dawley rat assessed as suppression of urine output at MED administered as iv infusion for 180 mins measured during compound dosing relative to control
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1178650Selectivity ratio of EC50 for human vasopressin V2 expressed in HEK293 cells to EC50 for human oxytocin receptor expressed in CHO-K1 cells2014Journal of medicinal chemistry, Jun-26, Volume: 57, Issue:12
New, potent, and selective peptidic oxytocin receptor agonists.
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1150895Antidiuretic activity in rat1976Journal of medicinal chemistry, Jun, Volume: 19, Issue:6
Synthesis and some pharmacological properties of deamino(4-threonine,8-D-arginine)vasopressin and deamino(8-D-arginine)vasopressin, highly potent and specific antidiuretic peptides, and (8-D-arginine)vasopressin and deamino-arginine-vasopressin.
AID1598526Elimination half life in human
AID1150894Activity at oxytocin receptor in rat uterus in presence of Mg2+1976Journal of medicinal chemistry, Jun, Volume: 19, Issue:6
Synthesis and some pharmacological properties of deamino(4-threonine,8-D-arginine)vasopressin and deamino(8-D-arginine)vasopressin, highly potent and specific antidiuretic peptides, and (8-D-arginine)vasopressin and deamino-arginine-vasopressin.
AID1150898Retardation factor of the compound by silica gel electrophoresis1976Journal of medicinal chemistry, Jun, Volume: 19, Issue:6
Synthesis and some pharmacological properties of deamino(4-threonine,8-D-arginine)vasopressin and deamino(8-D-arginine)vasopressin, highly potent and specific antidiuretic peptides, and (8-D-arginine)vasopressin and deamino-arginine-vasopressin.
AID277899Displacement of [3H]AVP from vasopressin V2 receptor in rat kidney membranes2007Journal of medicinal chemistry, Feb-22, Volume: 50, Issue:4
Design and synthesis of the first selective agonists for the rat vasopressin V(1b) receptor: based on modifications of deamino-[Cys1]arginine vasopressin at positions 4 and 8.
AID1882822Stability of the compound in simulated intestinal fluid at pH 6.8 assessed as half life measured up to 24 hrs by RP-HPLC-UV analysis2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
On the Utility of Chemical Strategies to Improve Peptide Gut Stability.
AID1598518Ratio of EC50 for agonist activity at recombinant rat V2 receptor expressed in HEK293 cells to EC50 for antidiuretic activity in hydrated-euvolemic Sprague-Dawley rat assessed as effective plasma concentration causing half-maximal suppression of urine out
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID173421Dose that reduces the response seen with 2x units of agonist to equal the response seen with 1x unit of agonist administered before antagonist; Agonist1989Journal of medicinal chemistry, Jan, Volume: 32, Issue:1
2-O-alkyltyrosine derivatives of 1-deamino-arginine-vasopressin: highly specific and potent antidiuretic agonists.
AID277900Displacement of [3H]AVP from vasopressin V1a receptor in rat liver membrane2007Journal of medicinal chemistry, Feb-22, Volume: 50, Issue:4
Design and synthesis of the first selective agonists for the rat vasopressin V(1b) receptor: based on modifications of deamino-[Cys1]arginine vasopressin at positions 4 and 8.
AID426923Antidiuretic activity in fasted and hydrated Wistar rat assessed as compound potency to yield antidiuresis time of 200 mins required for urinary excretion of half the water load at 0.001 to 100 nmol/kg, sc administered immediately after water loading by m2009European journal of medicinal chemistry, Jul, Volume: 44, Issue:7
Arginine vasopressin and its analogues--the influence of position 2 modification with 3,3-diphenylalanine enantiomers. Highly potent V2 agonists.
AID196847In vitro anti-oxytocic activity on isolated estrogen treated rat uteri with 0.5 mM Mg+2; Agonist1989Journal of medicinal chemistry, Jan, Volume: 32, Issue:1
2-O-alkyltyrosine derivatives of 1-deamino-arginine-vasopressin: highly specific and potent antidiuretic agonists.
AID1598507Non-renal clearance in nephrectomized Sprague-Dawley rat at 0.1 mg/kg, iv administered as cassette dose by LC-MS/MS analysis
AID1178649Agonist activity at human vasopressin V1b expressed in HEK293 cells after 5 hrs by firefly luciferase reporter gene assay2014Journal of medicinal chemistry, Jun-26, Volume: 57, Issue:12
New, potent, and selective peptidic oxytocin receptor agonists.
AID1598516Antidiuretic activity in hydrated-euvolemic Sprague-Dawley rat assessed as suppression of urine output by measuring cumulative urine weight at 30 pM administered as iv infusion for 180 mins measured up to 300 mins
AID1178657Partial agonist activity at human oxytocin receptor expressed in CHO-K1 cells after 5 hrs by firefly luciferase reporter gene assay2014Journal of medicinal chemistry, Jun-26, Volume: 57, Issue:12
New, potent, and selective peptidic oxytocin receptor agonists.
AID1150897Ratio of antidiuretic activity in rat to vasopressor activity in rat1976Journal of medicinal chemistry, Jun, Volume: 19, Issue:6
Synthesis and some pharmacological properties of deamino(4-threonine,8-D-arginine)vasopressin and deamino(8-D-arginine)vasopressin, highly potent and specific antidiuretic peptides, and (8-D-arginine)vasopressin and deamino-arginine-vasopressin.
AID1598512Elimination half life in Sprague-Dawley rat at 0.1 mg/kg, iv administered as cassette dose by LC-MS/MS analysis
AID1598508Protein binding in rat plasma at 200 to 1000 ng/ml measured after 15 mins by UC-LC/MS/MS analysis
AID1598514Antidiuretic activity in hydrated-euvolemic Sprague-Dawley rat assessed as effective plasma concentration causing half-maximal suppression of urine output administered as iv infusion for 180 mins measured during compound dosing
AID196969In vitro anti-oxytocic activity on isolated estrogen treated rat uteri without Mg+2; Agonist1989Journal of medicinal chemistry, Jan, Volume: 32, Issue:1
2-O-alkyltyrosine derivatives of 1-deamino-arginine-vasopressin: highly specific and potent antidiuretic agonists.
AID1598529Antidiuretic activity in iv dosed rat assessed as suppression of urine output relative to control
AID1598511Agonist activity at recombinant rat V2 receptor expressed in HEK293 cells measured after 5 hrs by cAMP response element driven luciferase reporter gene assay relative to control
AID168452Compound was tested for its antidiuretic activity1989Journal of medicinal chemistry, Jan, Volume: 32, Issue:1
2-O-alkyltyrosine derivatives of 1-deamino-arginine-vasopressin: highly specific and potent antidiuretic agonists.
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1150893Activity at oxytocin receptor in rat uterus1976Journal of medicinal chemistry, Jun, Volume: 19, Issue:6
Synthesis and some pharmacological properties of deamino(4-threonine,8-D-arginine)vasopressin and deamino(8-D-arginine)vasopressin, highly potent and specific antidiuretic peptides, and (8-D-arginine)vasopressin and deamino-arginine-vasopressin.
AID426916Agonist activity at vasopressin V1a receptor in phenoxybenzamine-treated Wistar rat uterus assessed as arterial vasopressor activity2009European journal of medicinal chemistry, Jul, Volume: 44, Issue:7
Arginine vasopressin and its analogues--the influence of position 2 modification with 3,3-diphenylalanine enantiomers. Highly potent V2 agonists.
AID1178648Agonist activity at human vasopressin V1a expressed in HEK293 cells after 5 hrs by firefly luciferase reporter gene assay2014Journal of medicinal chemistry, Jun-26, Volume: 57, Issue:12
New, potent, and selective peptidic oxytocin receptor agonists.
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1178652Selectivity ratio of EC50 for human vasopressin V1b expressed in HEK293 cells to EC50 for human oxytocin receptor expressed in CHO-K1 cells2014Journal of medicinal chemistry, Jun-26, Volume: 57, Issue:12
New, potent, and selective peptidic oxytocin receptor agonists.
AID1178656Clearance in Sprague-Dawley rat at 0.2 mg/kg, iv administered in cassette mode as bolus dose2014Journal of medicinal chemistry, Jun-26, Volume: 57, Issue:12
New, potent, and selective peptidic oxytocin receptor agonists.
AID1178661Partial agonist activity at human oxytocin receptor expressed in CHO-K1 cells after 5 hrs by firefly luciferase reporter gene assay relative to control2014Journal of medicinal chemistry, Jun-26, Volume: 57, Issue:12
New, potent, and selective peptidic oxytocin receptor agonists.
AID217394Binding affinity against human vasopressin V2 receptor was determined by using plasma membranes from CHO cells stably transfected with VP/OT receptors2004Journal of medicinal chemistry, Apr-22, Volume: 47, Issue:9
Design of potent and selective agonists for the human vasopressin V1b receptor based on modifications of [deamino-cys1]arginine vasopressin at position 4.
AID1598498Agonist activity at recombinant human V2 receptor expressed in HEK293 cells measured after 5 hrs by cAMP response element driven luciferase reporter gene assay
AID426920Antidiuretic activity in fasted and hydrated Wistar rat assessed as compound required to yield antidiuresis time of 60 mins required for urinary excretion of half the water load at 0.001 to 100 nmol/kg, sc administered immediately after water loading by m2009European journal of medicinal chemistry, Jul, Volume: 44, Issue:7
Arginine vasopressin and its analogues--the influence of position 2 modification with 3,3-diphenylalanine enantiomers. Highly potent V2 agonists.
AID1598515Antidiuretic activity in hydrated-euvolemic Sprague-Dawley rat assessed as suppression of urine output by measuring cumulative urine weight administered as iv infusion for 180 mins measured during compound dosing
AID1178653Antagonist activity at human vasopressin V1a expressed in AVP-stimulated HEK293 cells after 5 hrs by firefly luciferase reporter gene assay2014Journal of medicinal chemistry, Jun-26, Volume: 57, Issue:12
New, potent, and selective peptidic oxytocin receptor agonists.
AID217360Binding affinity against human vasopressin V1b receptor was determined by using plasma membranes from CHO cells stably transfected with VP/OT receptors2004Journal of medicinal chemistry, Apr-22, Volume: 47, Issue:9
Design of potent and selective agonists for the human vasopressin V1b receptor based on modifications of [deamino-cys1]arginine vasopressin at position 4.
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1598499Agonist activity at human OTR stably expressed in CHOK1 cells by NFAT-luciferase reporter gene assay
AID1598505Agonist activity at recombinant human V1a receptor expressed in HEK293 cells up to 1000 nM measured after 5 hrs by luciferase reporter gene assay
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1598500Agonist activity at human OTR stably expressed in CHOK1 cells by NFAT-luciferase reporter gene assay relative to control
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1178647Agonist activity at human vasopressin V2 expressed in HEK293 cells after 5 hrs by firefly luciferase reporter gene assay2014Journal of medicinal chemistry, Jun-26, Volume: 57, Issue:12
New, potent, and selective peptidic oxytocin receptor agonists.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1178646Agonist activity at human oxytocin receptor expressed in CHO-K1 cells after 5 hrs by firefly luciferase reporter gene assay2014Journal of medicinal chemistry, Jun-26, Volume: 57, Issue:12
New, potent, and selective peptidic oxytocin receptor agonists.
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1882821Stability of the compound in simulated gastric fluid at pH 1.2 assessed as half life measured up to 24 hrs by RP-HPLC-UV analysis2022Journal of medicinal chemistry, 04-28, Volume: 65, Issue:8
On the Utility of Chemical Strategies to Improve Peptide Gut Stability.
AID1598525Clearance in iv dosed over hydrated human
AID1598528Elimination half life in severe renal impairment patent
AID1178651Selectivity ratio of EC50 for human vasopressin V1a expressed in HEK293 cells to EC50 for human oxytocin receptor expressed in CHO-K1 cells2014Journal of medicinal chemistry, Jun-26, Volume: 57, Issue:12
New, potent, and selective peptidic oxytocin receptor agonists.
AID1598520Antidiuretic activity in hydrated-euvolemic Sprague-Dawley rat assessed as suppression of urine output at 30 pM administered as iv infusion for 180 mins measured after 5 hrs
AID426922Antidiuretic activity in fasted and hydrated Wistar rat assessed as compound potency to yield antidiuresis time of 60 mins required for urinary excretion of half the water load at 0.001 to 100 nmol/kg, sc administered immediately after water loading by mo2009European journal of medicinal chemistry, Jul, Volume: 44, Issue:7
Arginine vasopressin and its analogues--the influence of position 2 modification with 3,3-diphenylalanine enantiomers. Highly potent V2 agonists.
AID1598502Agonist activity at recombinant human V1B receptor expressed in HEK293 cells measured after 5 hrs by luciferase reporter gene assay relative to control
AID277897Activity at OT receptor assessed as oxytocic activity in absence of magnesium2007Journal of medicinal chemistry, Feb-22, Volume: 50, Issue:4
Design and synthesis of the first selective agonists for the rat vasopressin V(1b) receptor: based on modifications of deamino-[Cys1]arginine vasopressin at positions 4 and 8.
AID1598501Agonist activity at recombinant human V1B receptor expressed in HEK293 cells measured after 5 hrs by luciferase reporter gene assay
AID277896Vasopressor activity in rat2007Journal of medicinal chemistry, Feb-22, Volume: 50, Issue:4
Design and synthesis of the first selective agonists for the rat vasopressin V(1b) receptor: based on modifications of deamino-[Cys1]arginine vasopressin at positions 4 and 8.
AID235494Selectivity index of human V1b receptor towards V2 receptor2004Journal of medicinal chemistry, Apr-22, Volume: 47, Issue:9
Design of potent and selective agonists for the human vasopressin V1b receptor based on modifications of [deamino-cys1]arginine vasopressin at position 4.
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1598506Clearance in Sprague-Dawley rat at 0.1 mg/kg, iv administered as cassette dose by LC-MS/MS analysis
AID1150896Vasopressor activity in rat1976Journal of medicinal chemistry, Jun, Volume: 19, Issue:6
Synthesis and some pharmacological properties of deamino(4-threonine,8-D-arginine)vasopressin and deamino(8-D-arginine)vasopressin, highly potent and specific antidiuretic peptides, and (8-D-arginine)vasopressin and deamino-arginine-vasopressin.
AID1598504Selectivity ratio of EC50 for recombinant human V1B receptor expressed in HEK293 cells to EC50 for recombinant human V2 receptor expressed in HEK293 cells
AID1598521Half life in iv dosed Sprague-Dawley rat by LC-MS/MS analysis
AID1598510Agonist activity at recombinant rat V2 receptor expressed in HEK293 cells measured after 5 hrs by cAMP response element driven luciferase reporter gene assay
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID277895Antidiuretic activity in rat2007Journal of medicinal chemistry, Feb-22, Volume: 50, Issue:4
Design and synthesis of the first selective agonists for the rat vasopressin V(1b) receptor: based on modifications of deamino-[Cys1]arginine vasopressin at positions 4 and 8.
AID230906Ratio of antidiuretic to vasopressor agonistic activity1989Journal of medicinal chemistry, Jan, Volume: 32, Issue:1
2-O-alkyltyrosine derivatives of 1-deamino-arginine-vasopressin: highly specific and potent antidiuretic agonists.
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID217087Binding affinity against human vasopressin V1a receptor was determined by using plasma membranes from CHO cells stably transfected with VP/OT receptors2004Journal of medicinal chemistry, Apr-22, Volume: 47, Issue:9
Design of potent and selective agonists for the human vasopressin V1b receptor based on modifications of [deamino-cys1]arginine vasopressin at position 4.
AID1598527Clearance in severe renal impairment patent
AID426914Agonist activity at oxytocin receptor in Wistar rat uterus assessed as uterotonic activity in absence of Mg2+2009European journal of medicinal chemistry, Jul, Volume: 44, Issue:7
Arginine vasopressin and its analogues--the influence of position 2 modification with 3,3-diphenylalanine enantiomers. Highly potent V2 agonists.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (4,179)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990927 (22.18)18.7374
1990's1115 (26.68)18.2507
2000's1023 (24.48)29.6817
2010's856 (20.48)24.3611
2020's258 (6.17)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 27.04

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be moderate demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index27.04 (24.57)
Research Supply Index8.50 (2.92)
Research Growth Index4.56 (4.65)
Search Engine Demand Index38.14 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (27.04)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials516 (11.74%)5.53%
Reviews689 (15.67%)6.00%
Case Studies841 (19.13%)4.05%
Observational17 (0.39%)0.25%
Other2,333 (53.07%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (81)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Is Mirabegron 25 mg Safe and Effective in Treatment of Primary Nocturnal Enuresis as Regard Oral Desmopressin 120 mcg? [NCT05617664]150 participants (Anticipated)Interventional2022-11-23Recruiting
Effect of Aspirin, in Vitro Hemodilution and Desmopressin on Platelet Dysfunction Associated With Mild Hypothermia in Healthy Volunteers [NCT01382134]60 participants (Actual)Interventional2011-07-31Completed
A Randomised, Double-blind, Placebo-controlled, Response-adaptive Dose-finding Trial Investigating the Efficacy, Safety and Tolerability of Oral Doses of FE 201836, With Desmopressin Orally Disintegrating Tablet as a Benchmark, During 12 Weeks of Treatmen [NCT03201419]Phase 2302 participants (Actual)Interventional2017-07-27Completed
Efficacy and Safety of Desmopressin Combined With Tranexamic Acid on the Blood Loss and Transfusion Need During and After Scoliosis Correction Surgery [NCT02084342]60 participants (Anticipated)Interventional2013-12-31Active, not recruiting
Usage of Desmopressin fo Improving Nocturnal Enuresis in Patients After Radical Cystectomy With Orthotopic Bladder Reconstruction [NCT01582542]Phase 450 participants (Anticipated)Interventional2012-04-30Active, not recruiting
Peroral Administration of Different Doses of Desmopressin Administered as a New Orally-Disintegrating Tablet and Desmopressin for Nasal Administration in the Treatment of CDI in Japanese Patients [NCT01280188]Phase 320 participants (Actual)Interventional2011-01-31Completed
Influence of Food-intake on Pharmacokinetic and Pharmacodynamic Parameters of Desmopressin Oral Tablet Formulation, in Comparison With Desmopressin MELT Formulation [NCT01036841]Phase 424 participants (Actual)Interventional2009-12-31Completed
Placebo-Controlled, Randomized, Double-Blind Trial of Prophylactic Desmopressin in Heart Valve Surgery [NCT03343418]Phase 4108 participants (Anticipated)Interventional2015-02-28Active, not recruiting
Post-authorisation Safety Study of NOCDURNA for the Symptomatic Treatment of Nocturia Due to Idiopathic Nocturnal Polyuria: A Multi-country Cohort Study Using Secondary Data [NCT04740645]300,000 participants (Anticipated)Observational2021-07-13Recruiting
A New Check-list Method Enhances the Treatment Compliance and Response of Simple Behavioral Therapy for Primary Monosymptomatic Nocturnal Enuresis. Prospective Randomised Controlled Trial. [NCT03510975]Phase 475 participants (Actual)Interventional2015-01-01Completed
To Evaluate the Renal Tubular Function Pre and Post Nephrectomy in Living Donors [NCT03676361]Phase 40 participants (Actual)Interventional2018-08-29Withdrawn(stopped due to Not initiated)
Documentation of the Efficacy of Desmopressin (MINIRIN Parenteral 4 Microgram/ml Solution for Injection) Within the Context of Surgical Procedures [NCT02368730]23 participants (Actual)Observational2015-06-30Completed
The Effect of Gender on Antidiuresis - Evaluated by Graded Low Dose Desmopressin Infusion [NCT02068560]64 participants (Actual)Interventional2012-05-31Completed
Effects of Desmopressin on Blood Loss and the Quality of the Surgical Field During Endoscopic Sinus Surgery [NCT02125188]Phase 460 participants (Anticipated)Interventional2014-01-31Completed
A Randomized Double-blinded Trial Comparing DEsmopressin to FEsoterodine in the Treatment of Severe Nocturia in Women Aged 65 and olDer: The DEFEND Trial [NCT02262936]Phase 2/Phase 34 participants (Actual)Interventional2015-07-31Terminated(stopped due to Poor recruitment)
Retrospective, Observational and Multicenter Study of Factors Influencing the Pharmacokinetic of the Factor VIII After Intravenous Desmopressin in Patients With Moderate or Minor Hemophilia A [NCT05628558]800 participants (Anticipated)Observational2020-07-01Recruiting
Study on the Therapeutic Schedule and Mechanism of Suoquan Mixture Combined With Desmopressin to Children's Monosymptomatic Enuresis [NCT03733873]400 participants (Actual)Interventional2018-09-01Completed
A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Demonstrate the Efficacy and Safety of Desmopressin Orally Disintegrating Tablet for the Treatment of Nocturia in Adult Females [NCT01223937]Phase 3268 participants (Actual)Interventional2010-11-30Completed
The Effect of Clinical Characterization of Children With Monosymptomatic Nocturnal Enuresis on the Efficacy of Desmopressin and Alarm Therapy. [NCT03389412]Phase 4324 participants (Actual)Interventional2017-10-01Completed
Intranasal DDAVP in Preventing Bleeding During Dental Extraction in Cirrhotic Patients [NCT00816127]36 participants (Actual)Interventional2003-10-31Completed
Safety Outcomes Post Kidney Biopsy - Randomized Clinical Evaluation of Efficacy of Desmopressin [NCT05467033]Phase 3424 participants (Anticipated)Interventional2022-09-01Recruiting
Characterization of Laboratory Response to DDAVP in Adult Hemophilia A Carriers [NCT02506023]Phase 12 participants (Actual)Interventional2015-07-31Completed
Specified Drug Use-results Survey (Long-term Use) on MINIRINMELT® OD Tablet 25μg / 50μg in Treatment for Male Nocturia Due to Nocturnal Polyuria [NCT04329975]1,087 participants (Actual)Observational [Patient Registry]2020-05-19Completed
Minirin Versus Oxybutynin for Nocturnal Enuresis in Children [NCT02538302]Phase 366 participants (Actual)Interventional2013-07-31Completed
Effect of Desmopressin on Platelet Dysfunction Associated With Mild Hypothermia in Healthy Volunteers [NCT00902057]Phase 448 participants (Anticipated)Interventional2009-06-30Not yet recruiting
Safety and Tolerability Analysis of Combining Desmopressin With Docetaxel for the Treatment of Castration-Resistant Prostate Cancer [NCT04113005]Early Phase 110 participants (Anticipated)Interventional2019-10-01Not yet recruiting
A Randomised, Double-blind, Placebo-controlled, Multi-centre Trial Investigating the Efficacy and Safety of Desmopressin (FE 992026) Orally Disintegrating Tablets During 12 Weeks of Treatment for Nocturia Due to Nocturnal Polyuria in Japanese Female Subje [NCT02905682]Phase 3190 participants (Actual)Interventional2016-09-30Completed
Desmopressin in the Treatment of Mixed Nocturia With Nocturnal Polyuria and Low Nocturnal Bladder Capacity [NCT00902655]Phase 4103 participants (Actual)Interventional2004-04-30Completed
Efficacy and Safety of Nocturin 0.1 mg Tablets in Treatment of Nocturia in Patients With Nocturnal Polyuria, Lower Urinary Tract Symptoms (LUTS) and Benign Prostate Syndrome (BPS). [NCT00902265]138 participants (Actual)Observational2009-02-28Completed
A Double Blind, Placebo Controlled, Randomized, Monocentre Cross-over Study to Investigate the Effect of Desmopressin on the Nocturnal Micturition Frequency in Patients With Parkinson Disease [NCT00806468]Phase 41 participants (Actual)Interventional2009-02-28Terminated(stopped due to lack of recruitment)
Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery [NCT00885924]Phase 417 participants (Actual)Interventional2009-03-31Terminated(stopped due to to include required number of patients took too much time)
A 6-week Open Label Cross-over Study With 2 Different Daily Doses of Minirin® Oral Lyophilisate (120 μg and 240 μg) and 2 Different Daily Doses of Minirin® Tablet (0.2 mg and 2 x 0.2 mg) in Children and Adolescents With Primary Nocturnal Enuresis (PNE) [NCT00209261]Phase 4221 participants (Actual)Interventional2004-12-31Completed
A Prospective Randomized Trial for the Use of DDAVP in the Reduction of Post-operative Ecchymosis in Rhinoplasty. [NCT01982760]Phase 214 participants (Actual)Interventional2013-12-31Terminated
Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement Surgery [NCT01994330]Phase 413 participants (Actual)Interventional2009-06-30Completed
A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-group, Comparative Trial to Investigate the Dose-Response of 4 Different Dose Levels of Minirin Melt and Placebo in Water-loaded Male and Female Japanese Nocturia Patients (Single Dose [NCT01184859]Phase 2116 participants (Actual)Interventional2010-07-31Completed
A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial With an Open-label Extension to Demonstrate the Efficacy and Safety of Desmopressin Orally Disintegrating Tablets for the Treatment of Nocturia in Adult Males [NCT01262456]Phase 3395 participants (Actual)Interventional2011-02-28Completed
Selective Serotonin Reuptake Inhibitors, Fluoxetine Versus the Standard Oral Desmopressin for Management of Mono-symptomatic Nocturnal Enuresis. A Randomised Controlled Trial [NCT06185361]60 participants (Actual)Interventional2022-12-01Active, not recruiting
The Effect of Oral Midodrine Versus Oral Desmopressin Acetate Use for Liberation From IV Noradrenaline in Intensive Care Unit Patients Recovering From Spinal Shock . [NCT04586790]Phase 290 participants (Anticipated)Interventional2020-10-15Recruiting
A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Trial Investigating the Efficacy and Safety of Two Different Dose Levels of Desmopressin for the Treatment of Nocturia in Adult Women [NCT01684800]Phase 2178 participants (Actual)Interventional2012-09-30Completed
An Open Randomized Controlled Trial of Desmopressin, and Dexamethasone as Adjunctive Therapy in Patients With Pulmonary Hemorrhage Associated With Leptospirosis [NCT00592566]Phase 2/Phase 364 participants (Actual)Interventional2003-07-31Terminated(stopped due to Numbe of eligible patients has been decreased over time.)
"A Multi-Center Extension Study Investigating the Long Term Efficacy and Safety of a Fast-Dissolving (Melt) Formulation of Desmopressin for the Treatment of Nocturia in Adults" [NCT00615836]Phase 3554 participants (Actual)Interventional2007-12-31Completed
Pharmacokinetics and Pharmacodynamics of Desmopressin Oral Lyophilisate Formulation in the Paediatric Population [NCT02584231]Phase 425 participants (Actual)Interventional2015-09-09Completed
Desmopressin for Reversal of Antiplatelet Drugs in Stroke Due to Haemorrhage (DASH) [NCT03696121]Phase 254 participants (Actual)Interventional2019-04-01Completed
Efficacy of Desmopressin (1-deamin0-8-D-arginine-vasopressin) in Reducing Active Microvascular Bleeding After Cardiac Surgery [NCT00337766]Phase 40 participants Interventional2006-06-30Completed
Comparison of Intranasal Desmopressin vs IV Ketorolac in Renal Colic Patients [NCT02937896]40 participants (Actual)Interventional2015-01-31Completed
A Randomised, Double-blind, Placebo-controlled, Multi-centre Trial Investigating the Efficacy and Safety of Desmopressin (FE 992026) Orally Disintegrating Tablets During 12 Weeks of Treatment for Nocturia Due to Nocturnal Polyuria in Japanese Male Subject [NCT02904759]Phase 3342 participants (Actual)Interventional2016-09-30Completed
Treatment and Management of Women With Bleeding Disorders [NCT00111215]100 participants Interventional2001-01-31Completed
Decline in Renal Concentration Ability in Lithium Treated Patients [NCT05307042]51 participants (Anticipated)Observational2022-05-31Not yet recruiting
Prospective, Randomized, Double-blind Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients [NCT01530451]Phase 39 participants (Actual)Interventional2012-03-31Terminated(stopped due to Insufficient funding)
The Pathophysiology and Treatment of Supine Hypertension in Patients With Autonomic Failure [NCT00223717]Phase 1152 participants (Actual)Interventional2001-01-31Completed
Study of Genetic Factors Influencing the Factor VIII Response to Desmopressin in Carriers of Hemophilia A: the GIDEHAC Study [NCT06020456]361 participants (Actual)Observational2022-01-01Completed
A Single/Multiple Ascending Dose Phase 1 Study of the Safety, Tolerability and Pharmacologic Activity of BT200 in Normal Human Volunteers [NCT04103034]Phase 1112 participants (Actual)Interventional2019-10-07Completed
Desmopressin Response in the Young: A Double-blind, Randomised, Placebo-controlled, Dose-titration Study With Three Different Doses (120 Mcg, 240 Mcg and 360 Mcg) of Desmopressin Administered as a New Melt Tablet in Children and Adolescents With Primary N [NCT00230594]Phase 3132 participants (Actual)Interventional2004-07-31Completed
"A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multi-Center Study With a Double Blind Extension Investigating the Efficacy and Safety of a Fast- Dissolving (Melt) Formulation of Desmopressin for the Treatment of Nocturia in Adults" [NCT00477490]Phase 3799 participants (Actual)Interventional2007-05-31Completed
Posterior Tibial Nerve Stimulation Vs Desmopressin In Children With Primary Monosymptomatic Nocturnal Enuresis [NCT04545931]Phase 480 participants (Anticipated)Interventional2020-03-15Recruiting
Prospective, Open-labelled, Phase II Study, of the Administration of Desmopressin in Patients With Colorectal Cancer, With or Without Metastasis, With Rectal Bleeding, Before Treatment With Surgery and/or Chemotherapy and/or Radiotherapy. [NCT01623206]Phase 230 participants (Actual)Interventional2013-04-30Completed
A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Trial Investigating the Efficacy and Safety of Two Different Dose Levels of Desmopressin for the Treatment of Nocturia in Adult Men [NCT01694498]Phase 2183 participants (Actual)Interventional2012-09-30Completed
Assessment of Analgesic Efficacy of Intranasal Desmopressin in the Treatment of Acute Pain in Patients With Renal Colic [NCT01742689]Phase 388 participants (Anticipated)Interventional2012-03-31Recruiting
A Double-blind, Randomised, Parallel-group Trial Investigating Sleep Behaviour and Daytime Performance in Nocturia Patients Treated With Desmopressin Orally Disintegrating Tablets as Compared to Placebo [NCT01779466]Phase 25 participants (Actual)Interventional2013-04-30Terminated(stopped due to Terminated due to lack of eligible patients)
Effect of Desmopressin on Platelet Function in CKD Patients on Antiplatelet Agent Who Need Emergent Temporary Catheter Insertion for Hemodialysis [NCT01841515]Phase 125 participants (Actual)Interventional2012-08-31Completed
Exercise Versus DDAVP in Patients With Mild Hemophilia A - is One Non-inferior to the Other and do They Work Additively in Improving Hemostasis? [NCT03379974]Phase 432 participants (Actual)Interventional2018-07-31Completed
Desmopressin Melt Therapy in Patients With Nocturnal Polyuria: a Pharmacokinetic/Dynamic Study [NCT01435083]Phase 450 participants (Actual)Interventional2011-11-30Completed
A Double-blind, Placebo-controlled, Phase III Comparative Study With FE992026 in Children and Adolescents With Reduced Night-time Urinary Osmolarity-type Nocturnal Enuresis [NCT01078753]Phase 389 participants (Actual)Interventional2010-01-31Completed
Desmopressin as a Therapy for Nocturnal Enuresis in Pediatric Patients With Sickle Cell Disease [NCT04420585]Phase 47 participants (Actual)Interventional2020-07-07Terminated(stopped due to We were not able to meet recruitment after 9 years of trying to enroll patients on different versions of the protocol and changing recruitment strategies.)
Outcome of Adding Desmopressin to Tamsulosin for Treatment of Nocturnal Polyurea in Patients With Benign Prostatic Obstruction [NCT05945420]Phase 4160 participants (Anticipated)Interventional2023-07-20Recruiting
Perioperative Administration of Desmopressin to Subjects With Breast Cancer: A Phase IIa, Dose-Escalation Study [NCT01606072]Phase 221 participants (Actual)Interventional2011-11-30Completed
[NCT00004364]5 participants Observational1995-12-31Active, not recruiting
[NCT00004363]0 participants Observational1995-12-31Completed
Preoperative Nasal Desmopressin Versus Oral Bisoprolol for Controlling Bleeding and Improving Surgical Field During Unilateral Functional Endoscopic Sinus Surgery [NCT05430048]Phase 2100 participants (Actual)Interventional2022-07-01Completed
A Multi-Centre Trial Investigating the Long Term Safety and Tolerability of Desmopressin (FE 992026) Orally Disintegrating Tablets for the Treatment of Nocturia Due to Nocturnal Polyuria in Japanese Subjects [NCT03051009]Phase 3503 participants (Actual)Interventional2017-01-11Completed
Effects of Nasal Desmopressin Spray Versus Topical Epinephrine on Surgical Field Clarity and Hemodynamics in Endonasal Dacryocystorhinostomy: A Randomized Clinical Study. [NCT05507476]52 participants (Actual)Interventional2022-09-01Completed
DDAVP vs Exercise in Patients With Mild Hemophilia A - Which is Better and do They Work Synergistically in Improving Hemostasis? [NCT03136003]Phase 430 participants (Anticipated)Interventional2017-07-04Recruiting
A Double-blind, Randomized, Placebo-controlled Study Investigating the Impact Burden of Nocturia Using the Nocturia Impact Diary [NCT01552343]Phase 356 participants (Actual)Interventional2012-03-31Completed
Improving Platelet Activity for Cerebral Hemorrhage Treatment - DDAVP Proof of Concept [NCT00961532]Phase 214 participants (Actual)Interventional2010-12-31Completed
Effect of Laser Acupuncture for Treating Monosymptomatic Nocturnal Enuresis in Adolescent Females [NCT05399173]60 participants (Anticipated)Interventional2022-06-02Recruiting
A Multi-centre, Double-blind, Randomised Trial Investigating the Efficacy and Safety of a Combination Therapy, Desmopressin and Tolterodine, for Treatment of Overactive Bladder With Nocturia in Women [NCT01729819]Phase 2106 participants (Actual)Interventional2013-01-31Completed
Non-interventional Study on Safety and Efficacy of Minirin Melt® in Adult Patients With Nocturia [NCT03089073]835 participants (Actual)Observational2015-07-13Terminated(stopped due to Enrollment challenges)
Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of TEVA and Aventis Pharmaceuticals (DDAVP®) 0.2 mg Desmopressin Acetate Tablets in Healthy Adult Subjects Following a 0.8 mg Dose Under Fasting Conditions [NCT00835211]Phase 148 participants (Actual)Interventional2003-07-31Completed
Desmopressin as a Therapy for Nocturnal Enuresis in Patients With Sickle Cell Disease [NCT02636387]14 participants (Actual)Observational2015-08-26Terminated(stopped due to Low recruitment)
Desmopressin Melt: Impact on Sleep and Daytime Functioning? A Prospective Study. [NCT01645475]Phase 430 participants (Actual)Interventional2011-04-30Completed
Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic Study [NCT01439997]Phase 45 participants (Actual)Interventional2012-03-26Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00477490 (12) [back to overview]Part I: Change From Baseline in the Two Domain Scores of the Nocturia Quality of Life (NQoL) Questionnaire at Week 4
NCT00477490 (12) [back to overview]Part II: Percentage of Participants With Greater Than 33 Percent Reduction From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169
NCT00477490 (12) [back to overview]Part II: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part II
NCT00477490 (12) [back to overview]Part II: Change From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169
NCT00477490 (12) [back to overview]Part I: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part I
NCT00477490 (12) [back to overview]Part I: Change From Baseline in the Mental Health Summary and the Physical Health Summary of the Short Form-12 Version 2 (SF-12v2) at Week 4
NCT00477490 (12) [back to overview]Part I: Change From Baseline in Quality of Life Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) at Week 4
NCT00477490 (12) [back to overview]Part I: Percentage of Participants With Greater Than 33 Percent Reduction From Baseline in Mean Number of Nocturnal Voids at Week 4
NCT00477490 (12) [back to overview]Part I: Change From Baseline in Total Reported Sleep Time at Week 4
NCT00477490 (12) [back to overview]Part I: Change From Baseline in Quality of Sleep as Assessed by the Global Score of the Pittsburgh Sleep Quality Index (PSQI) at Week 4
NCT00477490 (12) [back to overview]Part I: Change From Baseline in Mean Number of Nocturnal Voids at Week 4
NCT00477490 (12) [back to overview]Part I: Change From Baseline in Initial Period of Undisturbed Sleep at Week 4
NCT00615836 (13) [back to overview]Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Mental Component Summary Score
NCT00615836 (13) [back to overview]Change From Baseline in the Nocturia Quality of Life (NQoL) Global Quality of Life Score
NCT00615836 (13) [back to overview]Change From Baseline in International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) Nighttime Urination Bother Score
NCT00615836 (13) [back to overview]Change From Baseline in Mean Number of Nocturnal Voids
NCT00615836 (13) [back to overview]Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score
NCT00615836 (13) [back to overview]Change From Baseline in Nocturia Quality of Life (NQoL) Overall Score
NCT00615836 (13) [back to overview]Change From Baseline in Nocturia Quality of Life (NQoL) Sleep/Energy Domain Score
NCT00615836 (13) [back to overview]Change From Baseline in NQoL Bother/Concern Domain Score
NCT00615836 (13) [back to overview]Percentage of Participants With a Greater Than 33% Reduction in the Mean Number of Nocturnal Voids
NCT00615836 (13) [back to overview]Participants With Treatment-Emergent Adverse Events (AEs)
NCT00615836 (13) [back to overview]Change From Baseline in Total Sleep Time
NCT00615836 (13) [back to overview]Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Physical Component Summary Score
NCT00615836 (13) [back to overview]Change From Baseline in Initial Period of Undisturbed Sleep
NCT00835211 (3) [back to overview]AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
NCT00835211 (3) [back to overview]AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
NCT00835211 (3) [back to overview]Cmax - Maximum Observed Concentration
NCT00902265 (9) [back to overview]Mean Change From Baseline International Prostate Symptom Score (IPSS) Quality of Life Score at Week 12
NCT00902265 (9) [back to overview]Mean Change From Baseline in Ratio of Nighttime Urine Volume to 24-hour Urine Volume at Week 12
NCT00902265 (9) [back to overview]Mean Change From Baseline in Total Score in Leeds Sleep Evaluation Questionnaire (LSEQ) at Week 12
NCT00902265 (9) [back to overview]Mean Change From Baseline in Initial Period of Undisturbed Sleep at Week 12
NCT00902265 (9) [back to overview]Mean Change From Baseline of Total International Prostate Symptom Score (IPSS) at Week 12
NCT00902265 (9) [back to overview]Overall Mean Change From Baseline in Mean Number of Nighttime Voids at Week 12
NCT00902265 (9) [back to overview]Participants With Treatment Emergent Adverse Events (AEs)
NCT00902265 (9) [back to overview]Change From Baseline in Degree of Bother Due to Frequency of Daytime Voiding Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N)
NCT00902265 (9) [back to overview]Change From Baseline in Degree of Bother Due to Frequency of Nighttime Voiding Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N)at Week 12
NCT00961532 (2) [back to overview]Adverse Events : New Fever >=100.4F, Respiratory Distress or Pulmonary Edema on Chest Radiography, Rash, Hypotension (Systolic BP < 100 mm Hg or New Vasopressor Use or Increase in Vasopressor Dose by >25%)
NCT00961532 (2) [back to overview]Change in Platelet Activity, Measured in Seconds on PFA-EPI Assay, From Pre to Post-treatment
NCT01078753 (3) [back to overview]Change in Number of Wet Nights Between Baseline and Treatment Period I
NCT01078753 (3) [back to overview]Change in Number of Wet Nights Between Treatment Periods I and II
NCT01078753 (3) [back to overview]Change in the Number of Wet Nights Between Baseline and Treatment Period II
NCT01184859 (16) [back to overview]Change From Baseline in Nocturia-Related Quality of Life Based on Evaluation Provided by Nocturia Quality of Life Questionnaire (N-QoL) at Approximately Day 32
NCT01184859 (16) [back to overview]Time When Urine Production <0.12 ml/kg/Min
NCT01184859 (16) [back to overview]Duration of Action Defined as the Time With Urine Osmolality Above 200 mOsm/kg - Period 1
NCT01184859 (16) [back to overview]Change From Baseline in Total Sleep Time at Approximately Day 32
NCT01184859 (16) [back to overview]Change From Baseline in Sleep Related Quality of Life Based on the Global Score of the Pittsburgh Sleep Quality Index (PSQI) at Approximately Day 32
NCT01184859 (16) [back to overview]Change From Baseline in Number of Nocturnal Voids After 28 Days of Treatment - Period 2
NCT01184859 (16) [back to overview]Change From Baseline in Number of 24-hour Urine Voids at Approximately Day 32
NCT01184859 (16) [back to overview]Change From Baseline in Nocturnal Urine Volume at Approximately Day 32
NCT01184859 (16) [back to overview]Area Under the Urine Osmolality Curve (AUCosm)
NCT01184859 (16) [back to overview]Change From Baseline in Number of Daytime Voids at Approximately Day 32
NCT01184859 (16) [back to overview]Change From Baseline in 24-Hour Urine Production Per Body Weight at Approximately Day 32
NCT01184859 (16) [back to overview]Change From Baseline in Nocturnal Polyuria Index at Approximately Day 32
NCT01184859 (16) [back to overview]Change From Baseline in 24-Hour Urine Volume at Approximately Day 32
NCT01184859 (16) [back to overview]Change From Baseline in Duration of First Period of Undisturbed Sleep After 28 Days of Treatment - Period 2
NCT01184859 (16) [back to overview]Participant Counts of Minimum Observed Serum Sodium Levels During the Second Treatment Period (Days 4-32)
NCT01184859 (16) [back to overview]Area Under the Urine Production Curve (AUCurine Prod)
NCT01223937 (9) [back to overview]Minimum Post-Treatment Serum Sodium Levels
NCT01223937 (9) [back to overview]Summary of Participants With Treatment-Emergent Adverse Events (TEAEs)
NCT01223937 (9) [back to overview]Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period
NCT01223937 (9) [back to overview]Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids at Month 3
NCT01223937 (9) [back to overview]Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids for All During-Treatment Visits up to Month 3
NCT01223937 (9) [back to overview]Change From Baseline in 24-Hour Urine Volume at Month 3
NCT01223937 (9) [back to overview]Change From Baseline in Mean Number of Nocturnal Voids at Month 3
NCT01223937 (9) [back to overview]Change From Baseline in Mean Time to First Nocturnal Void at Month 3
NCT01223937 (9) [back to overview]Change From Baseline in Nocturnal Urine Volume at Month 3
NCT01262456 (11) [back to overview]Change From Baseline in Mean Number of Nocturnal Voids at Month 3
NCT01262456 (11) [back to overview]Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Period
NCT01262456 (11) [back to overview]Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids at Month 3
NCT01262456 (11) [back to overview]Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids for All During-Treatment Visits up to Month 3
NCT01262456 (11) [back to overview]Change From Baseline in 24-Hour Urine Volume at Month 3
NCT01262456 (11) [back to overview]Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Period
NCT01262456 (11) [back to overview]Change From Baseline in Mean Time to First Nocturnal Void at Month 3
NCT01262456 (11) [back to overview]Change From Baseline in Nocturnal Urine Volume at Month 3
NCT01262456 (11) [back to overview]Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period
NCT01262456 (11) [back to overview]Minimum Post-Treatment Serum Sodium Levels in the Double-Blind Period
NCT01262456 (11) [back to overview]Minimum Post-Treatment Serum Sodium Levels in the Open-Label Period
NCT01552343 (8) [back to overview]Cohen's D Effect Size in Responsiveness in the Nocturia Impact (NI) Total Scores and Overall Impact Question as Measured From Baseline (Day 1) to Month 1
NCT01552343 (8) [back to overview]Change From Baseline to Month 1 on Nocturia Impact (NI) Total Score
NCT01552343 (8) [back to overview]Construct Validity For the Nocturia Impact (NI) Total Scores and Overall Impact Question (Q12) for Participants With High/Low Number of Nocturnal Voids
NCT01552343 (8) [back to overview]Difference in Mean Change From Baseline to Month 1 in Nocturia Impact (NI) Total Scores and Overall Impact Question for Responders and Non-Responders
NCT01552343 (8) [back to overview]Internal Consistency of the Nocturia Impact (NI) Total Score for Each Day NI Diaries Were Completed Assessed as Cronbach's Alpha Values
NCT01552343 (8) [back to overview]Minimum Post-Treatment Serum Sodium Levels
NCT01552343 (8) [back to overview]Summary of Participants With Treatment-Emergent Adverse Events (TEAEs)
NCT01552343 (8) [back to overview]The Pearson Correlation Coefficient Between Change From Baseline to Month 1 in Number of Nocturnal Voids and Change From Baseline to Month 1 in Nocturia Impact (NI) Diary Total Score
NCT01729819 (6) [back to overview]Change in Mean Number of Nocturnal Voids From Baseline
NCT01729819 (6) [back to overview]Change in Mean Time to First Nocturnal Void From Baseline
NCT01729819 (6) [back to overview]Responder Status
NCT01729819 (6) [back to overview]Change in the Impact on Sleep as Measured by the Sleep Rating Scales From Baseline
NCT01729819 (6) [back to overview]Onset of Effect as Seen in Change in Mean Number of Nocturnal Voids From Baseline for Each Visit During Three Months of Treatment
NCT01729819 (6) [back to overview]Change in Mean Nocturnal Urine Volume From Baseline
NCT03201419 (46) [back to overview]Change From Baseline in PGI-S Scores at Week 8
NCT03201419 (46) [back to overview]Change From Baseline in PGI-S Scores at Week 4
NCT03201419 (46) [back to overview]Change From Baseline in PGI-S Scores at Week 12
NCT03201419 (46) [back to overview]Change From Baseline in Patient Global Impression of Severity (PGI-S) Scores at Week 1
NCT03201419 (46) [back to overview]Change From Baseline in Nocturnal Diuresis Rate Profiles at Week 12
NCT03201419 (46) [back to overview]Change From Baseline in Nocturnal Diuresis Rate Profiles at Week 1
NCT03201419 (46) [back to overview]Change From Baseline in Mean NUV in Week 1
NCT03201419 (46) [back to overview]Change From Baseline in Mean NUV at Week 12
NCT03201419 (46) [back to overview]Change From Baseline in Mean Number of Nocturnal Voids at Week 8
NCT03201419 (46) [back to overview]Change From Baseline in Mean Number of Nocturnal Voids at Week 4
NCT03201419 (46) [back to overview]Change From Baseline in Aggregated Mean Duration of FUSP During 12 Weeks of Treatment
NCT03201419 (46) [back to overview]Change From Baseline in Mean Number of Nocturnal Voids at Week 1
NCT03201419 (46) [back to overview]Change From Baseline in Mean NI Diary Total Score at Week 8
NCT03201419 (46) [back to overview]Change From Baseline in Mean NI Diary Total Score at Week 4
NCT03201419 (46) [back to overview]Change From Baseline in Mean NI Diary Total Score at Week 12
NCT03201419 (46) [back to overview]Change From Baseline in Mean NI Diary Total Score at Week 1
NCT03201419 (46) [back to overview]Change From Baseline in Mean NI Diary Overall Impact Score at Week 8
NCT03201419 (46) [back to overview]Change From Baseline in Mean NI Diary Overall Impact Score at Week 12
NCT03201419 (46) [back to overview]Change From Baseline in Mean NI Diary Overall Impact Score at Week 1
NCT03201419 (46) [back to overview]Change From Baseline in Mean Duration of FUSP at Week 8
NCT03201419 (46) [back to overview]Change From Baseline in Mean Duration of FUSP at Week 4
NCT03201419 (46) [back to overview]Change From Baseline in Mean Duration of FUSP at Week 12
NCT03201419 (46) [back to overview]Change From Baseline in Mean Duration of First Undisturbed Sleep Period (FUSP) at Week 1
NCT03201419 (46) [back to overview]Change From Baseline in ISI at Week 8
NCT03201419 (46) [back to overview]Change From Baseline in ISI at Week 4
NCT03201419 (46) [back to overview]Change From Baseline in ISI at Week 12
NCT03201419 (46) [back to overview]Change From Baseline in Hsu 5-point Likert Bother Scale at Week 8
NCT03201419 (46) [back to overview]Change From Baseline in Aggregated Mean NI Diary Overall Impact Score During 12 Weeks of Treatment
NCT03201419 (46) [back to overview]Change From Baseline in Mean NI Diary Overall Impact Score at Week 4
NCT03201419 (46) [back to overview]Change From Baseline in Aggregated Mean NI Diary Total Score During 12 Weeks of Treatment
NCT03201419 (46) [back to overview]Responder Rate in Nocturnal Voids During 12 Weeks of Treatment
NCT03201419 (46) [back to overview]Responder Rate in Nocturnal Voids at Week 8
NCT03201419 (46) [back to overview]Responder Rate in Nocturnal Voids at Week 4
NCT03201419 (46) [back to overview]Responder Rate in Nocturnal Voids at Week 12
NCT03201419 (46) [back to overview]Responder Rate in Nocturnal Voids at Week 1
NCT03201419 (46) [back to overview]Change From Baseline in Hsu 5-point Likert Bother Scale at Week 4
NCT03201419 (46) [back to overview]Change From Baseline in Hsu 5-point Likert Bother Scale at Week 12
NCT03201419 (46) [back to overview]Change From Baseline in Mean Number of Nocturnal Voids at Week 12
NCT03201419 (46) [back to overview]Percentage of Nights With at Most One Nocturnal Void During 12 Weeks of Treatment
NCT03201419 (46) [back to overview]Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 8
NCT03201419 (46) [back to overview]Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 4
NCT03201419 (46) [back to overview]Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 12
NCT03201419 (46) [back to overview]Percentage of Nights With No Nocturnal Voids During 12 Weeks of Treatment
NCT03201419 (46) [back to overview]Change From Baseline in Hsu 5-point Likert Bother Scale at Week 1
NCT03201419 (46) [back to overview]Change From Baseline in Aggregated Mean Number of Nocturnal Voids During 12 Weeks of Treatment
NCT03201419 (46) [back to overview]Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 1

Part I: Change From Baseline in the Two Domain Scores of the Nocturia Quality of Life (NQoL) Questionnaire at Week 4

The NQoL questionnaire is a self-administered questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question. The twelve core questions are scored on a 0 to 4 scale with higher numbers indicating a better quality of life. Domain summary scores were calculated by transforming the raw score into a 0-100 scale with higher numbers indicating a better quality of life. (NCT00477490)
Timeframe: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)

,,,,
Interventionunits on a scale (Mean)
Sleep/Energy DomainBother/Concern Domain
Desmopressin Melt 10 μg12.314.7
Desmopressin Melt 100 μg16.318.2
Desmopressin Melt 25 μg14.615.7
Desmopressin Melt 50 μg14.715.2
Placebo15.212.7

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Part II: Percentage of Participants With Greater Than 33 Percent Reduction From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169

Part II outcomes tested the durability of the effect observed in Part I. Percentage of participants in each treatment arm that had a greater than 33% reduction from baseline to Days 29, 57, 113 and 169 in mean number of nocturnal voids. Nocturnal void data were recorded in participant diaries. (NCT00477490)
Timeframe: - Week 3 to Day 1 (Baseline), Days 29, 57, 113 and 169

,,,,,,,
Interventionpercentage of participants (Number)
Day 29 (n=104,100,93,104,22,28,27,22)Day 57 (n=86,85,78,81,17,24,21,16)Day 113 (n=53,56,49,47,11,15,13,11)Day 169 (n=17,15,17,15,3,3,4,2)
Desmopressin Melt 10 μg57595861
Desmopressin Melt 100 μg68838787
Desmopressin Melt 25 μg64687980
Desmopressin Melt 50 μg68716976
Placebo to 10 μg734155100
Placebo to 100 μg736973100
Placebo to 25 μg43717367
Placebo to 50 μg484354100

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Part II: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part II

A treatment-emergent adverse event (AE) was any AE occurring during the treatment period or a pretreatment AE that worsened in intensity during the treatment period. The treatment period was the period during which a subject received investigational medicinal product. If a subject discontinued the investigational medicinal product, the date of last dose was the last day of the treatment period. (NCT00477490)
Timeframe: Week 5 up to Day 169

,,,,,,,
Interventionparticipants (Number)
All AEsDeathsSerious AEsAEs leading to discontinuationSevere AEsAdverse Drug Reactions
Desmopressin Melt 10 μg95033764
Desmopressin Melt 100 μg100024568
Desmopressin Melt 25 μg95013459
Desmopressin Melt 50 μg92002958
Placebo to 10 μg20001110
Placebo to 100 μg28025118
Placebo to 25 μg27002316
Placebo to 50 μg25022215

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Part II: Change From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169

Part II outcomes tested the durability of the effect observed in Part I. The number of nocturnal voids was the average over 3 consecutive 24-hours periods prior to Part I baseline and prior to the Part II visit as recorded in participant diaries. (NCT00477490)
Timeframe: - Week 3 to Day 1 (Baseline), Days 29, 57, 113 and 169

,,,,,,,
Interventionnocturnal voids (Mean)
Day 29 (n=104,100,93,104,22,28,27,22)Day 57 (n=86,85,78,81,17,24,21,16)Day 113 (n=53,56,49,47,11,15,13,11)Day 169 (n=17,15,17,15,3,3,4,2)
Desmopressin Melt 10 μg-1.12-1.14-1.31-1.47
Desmopressin Melt 100 μg-1.47-1.74-1.95-1.76
Desmopressin Melt 25 μg-1.31-1.42-1.56-1.71
Desmopressin Melt 50 μg-1.43-1.50-1.65-1.65
Placebo to 10 μg-1.20-1.08-0.76-1.78
Placebo to 100 μg-1.58-1.35-1.76-2.50
Placebo to 25 μg-1.19-1.53-1.67-2.00
Placebo to 50 μg-1.00-1.03-1.21-2.33

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Part I: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part I

A treatment-emergent adverse event (AE) was any AE occurring during the treatment period or a pretreatment AE that worsened in intensity during the treatment period. The treatment period was the period during which a subject received investigational medicinal product. If a subject discontinued the investigational medicinal product, the date of last dose was the last day of the treatment period. (NCT00477490)
Timeframe: Day 1 up to Week 4 (end of Part I)

,,,,
Interventionparticipants (Number)
All AEsDeathsSerious AEsAEs leading to discontinuationSevere AEsAdverse drug reactions (ADRs)
Desmopressin Melt 10 μg100026862
Desmopressin Melt 100 μg1100013780
Desmopressin Melt 25 μg98012561
Desmopressin Melt 50 μg10302131373
Placebo94018462

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Part I: Change From Baseline in the Mental Health Summary and the Physical Health Summary of the Short Form-12 Version 2 (SF-12v2) at Week 4

The SF-12v2 was used to measure the impact of nocturia and lack of sleep on general quality of life. The SF-12 consists of 12 questions. Data were analyzed using norm-based scoring and summarized along 2 dimensions: Physical Health Summary and Mental Health Summary. Each summary has a range from 0 (poor health) to 100 (highest level of health). Higher numbers indicate better quality of life. (NCT00477490)
Timeframe: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)

,,,,
Interventionunits on a scale (Mean)
Mental Health SummaryPhysical Health Summary
Desmopressin Melt 10 μg2.50.5
Desmopressin Melt 100 μg1.72.3
Desmopressin Melt 25 μg2.11.2
Desmopressin Melt 50 μg2.20.6
Placebo2.41.0

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Part I: Change From Baseline in Quality of Life Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) at Week 4

The ICIQ-N is a self-administered questionnaire designed to assess the frequency and bother of daytime and nighttime urination. Subjects were asked to rate the degree of bother of daytime urination and nighttime urination on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate lower quality of life. (NCT00477490)
Timeframe: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)

,,,,
Interventionunits on a scale (Mean)
Daytime urination: How much does it bother you?Nighttime urination: How much does it bother you?
Desmopressin Melt 10 μg-0.7-1.8
Desmopressin Melt 100 μg-1.0-2.5
Desmopressin Melt 25 μg-0.9-2.1
Desmopressin Melt 50 μg-0.7-2.2
Placebo-0.7-1.4

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Part I: Percentage of Participants With Greater Than 33 Percent Reduction From Baseline in Mean Number of Nocturnal Voids at Week 4

"Percentage of participants in each treatment arm that had a greater than 33% reduction from baseline to the end of Part I (week 4) in mean number of nocturnal voids. Nocturnal void data were recorded in participant diaries.~This was the second co-primary outcome." (NCT00477490)
Timeframe: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)

Interventionpercentage of participants (Number)
Placebo47
Desmopressin Melt 10 μg47
Desmopressin Melt 25 μg50
Desmopressin Melt 50 μg53
Desmopressin Melt 100 μg71

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Part I: Change From Baseline in Total Reported Sleep Time at Week 4

Total sleep time was recorded by participants in study diaries. (NCT00477490)
Timeframe: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)

Interventionminutes (Mean)
Placebo24.6
Desmopressin Melt 10 μg7.8
Desmopressin Melt 25 μg15.9
Desmopressin Melt 50 μg24.9
Desmopressin Melt 100 μg19.0

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Part I: Change From Baseline in Quality of Sleep as Assessed by the Global Score of the Pittsburgh Sleep Quality Index (PSQI) at Week 4

The PSQI is a self-administered 19-item questionnaire designed to assess sleep quality and disturbances. The global score ranges from 0 (better sleep quality) to 21 (worse sleep quality). Higher numbers indicate lower quality of life. (NCT00477490)
Timeframe: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)

Interventionunits on a scale (Mean)
Placebo-1.6
Desmopressin Melt 10 μg-1.6
Desmopressin Melt 25 μg-1.8
Desmopressin Melt 50 μg-2.0
Desmopressin Melt 100 μg-1.9

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Part I: Change From Baseline in Mean Number of Nocturnal Voids at Week 4

"The number of nocturnal voids was the average over 3 consecutive 24-hours periods prior to Day 1 and prior to the week 4 visit as recorded in participant diaries.~This was the first co-primary outcome." (NCT00477490)
Timeframe: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)

Interventionnocturnal voids (Mean)
Placebo-0.86
Desmopressin Melt 10 μg-0.83
Desmopressin Melt 25 μg-1.00
Desmopressin Melt 50 μg-1.18
Desmopressin Melt 100 μg-1.43

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Part I: Change From Baseline in Initial Period of Undisturbed Sleep at Week 4

Initial period of undisturbed sleep was the time elapsed from first falling asleep until either first void or morning arising. Data were captured in patient diaries. (NCT00477490)
Timeframe: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)

Interventionminutes (Mean)
Placebo38.7
Desmopressin Melt 10 μg50.9
Desmopressin Melt 25 μg82.7
Desmopressin Melt 50 μg85.1
Desmopressin Melt 100 μg106.7

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Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Mental Component Summary Score

"The SF-12v2 was used to measure the impact of nocturia and lack of sleep on general quality of life. The SF-12 consists of 12 questions spanning 8 domains: physical functioning, role function-physical, role function-emotional, bodily pain, general health, vitality, social functioning, and mental health. These scales are combined to create 2 summary measures: the Physical Health Summary and Mental Health Summary. The Mental Health Summary score ranges from 0 to 100, where higher numbers indicate better quality of life.~Participants in the 10μg arm are included only until the time of dose escalation." (NCT00615836)
Timeframe: Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)

,,,
Interventionunits on a scale (Mean)
Week 16 [N=34, 42, 44, 34]Visit 12 [N=0, 82, 73, 66]End of Study [N=17, 91, 81, 80]
Desmopressin Melt 10 μg5.82NA-0.49
Desmopressin Melt 100 μg4.140.141.30
Desmopressin Melt 25 μg3.840.533.15
Desmopressin Melt 50 μg1.571.391.77

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Change From Baseline in the Nocturia Quality of Life (NQoL) Global Quality of Life Score

"The NQoL is a self-administered 13-item questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question. The global QoL question is scored on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate better impact on quality of life.~Participants in the 10μg arm are included only until the time of dose escalation." (NCT00615836)
Timeframe: Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)

,,,
Interventionunits on a scale (Mean)
Week 16 [N=34, 42, 44, 35]Visit 12 [N=0, 85, 77, 69]End of Study [N=17, 93, 85, 81]
Desmopressin Melt 10 μg0.29NA0.18
Desmopressin Melt 100 μg0.260.460.43
Desmopressin Melt 25 μg0.360.380.34
Desmopressin Melt 50 μg0.680.480.47

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Change From Baseline in International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) Nighttime Urination Bother Score

"The ICIQ-N is a self-administered 4-item questionnaire designed to assess the frequency and bother of daytime and nighttime urination. To assess nighttime urination bother, participants were asked to rate the degree of bother of nighttime urination by answering the question Night time urination: How much does this bother you? on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate greater bother.~Participants in the 10μg arm are included only until the time of dose escalation." (NCT00615836)
Timeframe: Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)

,,,
Interventionunits on a scale (Mean)
Week 16 [N=34, 42, 44, 35]Visit 12 [N=0, 84, 77, 67]End of Study [N=17, 93, 84, 82]
Desmopressin Melt 10 μg-3.68NA-3.12
Desmopressin Melt 100 μg-3.71-4.12-3.62
Desmopressin Melt 25 μg-2.62-2.83-2.96
Desmopressin Melt 50 μg-3.77-3.77-3.46

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Change From Baseline in Mean Number of Nocturnal Voids

"Participants completed a voiding diary for 3 consecutive 24-hour periods prior to the study visit in which they recorded each nocturnal urination (void). The mean number of voids per night was the average number of voids from the 3-day diary. Baseline refers to Baseline of Study CS29 and the number of weeks represents the total exposure to study drug.~Participants in the 10μg arm are included only until the time of dose escalation." (NCT00615836)
Timeframe: Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.

,,,
Interventionnocturnal voids (Mean)
8 Weeks [N=103, 96, 92, 104]12 Weeks [N=85, 81, 77, 81]20 Weeks [N=62, 58, 64, 64]28 Weeks [N=63, 85, 62, 62]52-56 Weeks [N=45, 91, 81, 77]72-76 Weeks [N=0, 79, 72, 67]92-96 Weeks [N=0, 68, 62, 62]
Desmopressin Melt 10 μg-1.12-1.15-1.25-1.47-1.79NANA
Desmopressin Melt 100 μg-1.47-1.73-1.86-1.81-2.14-2.24-2.09
Desmopressin Melt 25 μg-1.30-1.40-1.61-1.36-1.40-1.51-1.39
Desmopressin Melt 50 μg-1.42-1.48-1.69-1.49-1.78-1.86-1.91

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Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score

"The PSQI is a self-administered 19-item questionnaire designed to assess sleep quality and disturbances. The 19 individual items are scored on an evenly weighted 0 to 3 scale and generate 7 component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these 7 components yields 1 global score ranging from 0 to 21. Higher numbers indicate greater sleep disturbance.~Participants in the 10μg arm are included only until the time of dose escalation." (NCT00615836)
Timeframe: Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)

,,,
Interventionunits on a scale (Mean)
Week 16 [N=32, 39, 42, 34]Visit 12 [N=0, 80, 73, 65]End of Study [N=16, 89, 78, 78]
Desmopressin Melt 10 μg-2.41NA-1.69
Desmopressin Melt 100 μg-2.94-2.66-1.54
Desmopressin Melt 25 μg-2.59-1.59-2.12
Desmopressin Melt 50 μg-3.52-2.99-2.88

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Change From Baseline in Nocturia Quality of Life (NQoL) Overall Score

"The NQoL is a self-administered 13-item questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question (which is not included in the overall score). The 12 core items are scored on a 0 to 4 scale, and the overall score is calculated by transforming the raw score into a 0-100 scale with higher numbers indicating better impact on quality of life.~Participants in the 10μg arm are included only until the time of dose escalation." (NCT00615836)
Timeframe: Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)

,,,
Interventionunits on a scale (Mean)
Week 16 [N=34, 42, 44, 35]Visit 12 [N=0, 84, 77, 66]End of Study [N=17, 94, 85, 80]
Desmopressin Melt 10 μg20.16NA12.87
Desmopressin Melt 100 μg26.1319.8918.36
Desmopressin Melt 25 μg22.4219.3717.46
Desmopressin Melt 50 μg22.0621.5119.13

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Change From Baseline in Nocturia Quality of Life (NQoL) Sleep/Energy Domain Score

"The NQoL is a self-administered 13-item questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question. The 12 core items are scored on a 0 to 4 scale with higher numbers indicating a better quality of life. The sleep/energy domain summary score is calculated by transforming the raw score into a 0-100 scale with higher numbers indicating a better impact on quality of life.~Participants in the 10μg arm are included only until the time of dose escalation." (NCT00615836)
Timeframe: Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)

,,,
Interventionunits on a scale (Mean)
Week 16 [N=34, 42, 44, 35]Visit 12 [N=0, 85, 77, 66]End of Study [N=17, 93, 84, 81]
Desmopressin Melt 10 μg17.89NA12.01
Desmopressin Melt 100 μg23.4522.6620.58
Desmopressin Melt 25 μg22.0220.2020.30
Desmopressin Melt 50 μg20.8323.3221.83

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Change From Baseline in NQoL Bother/Concern Domain Score

"The NQoL is a self-administered 13-item questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question. The 12 core items are scored on a 0 to 4 scale with higher numbers indicating a better quality of life. The bother/concern domain summary score is calculated by transforming the raw score into a 0-100 scale with higher numbers indicating a better impact on quality of life.~Participants in the 10μg arm are included only until the time of dose escalation." (NCT00615836)
Timeframe: Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)

,,,
Interventionunits on a scale (Mean)
Week 16 [N=34, 42, 44, 35]Visit 12 [N=0, 83, 77, 66]End of Study [N=17, 94, 84, 80]
Desmopressin Melt 10 μg22.43NA13.73
Desmopressin Melt 100 μg28.8117.1116.25
Desmopressin Melt 25 μg22.8218.2714.23
Desmopressin Melt 50 μg23.3019.7016.47

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Percentage of Participants With a Greater Than 33% Reduction in the Mean Number of Nocturnal Voids

"Percentage of participants with >33% reduction from Baseline in the mean number of nocturnal urinations per night, calculated from the 3-day voiding diary completed prior to each study visit.~Participants in the 10μg arm are included only until the time of dose escalation." (NCT00615836)
Timeframe: Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.

,,,
Interventionpercentage of participants (Number)
8 Weeks [N=103, 96, 92, 104]12 Weeks [N=85, 81, 77, 81]20 Weeks [N=62, 58, 64, 64]28 Weeks [N=63, 85, 62, 62]52-56 Weeks [N=45, 91, 81, 77]72-76 Weeks [N=0, 79, 72, 67]92-96 Weeks [N=0, 68, 62, 62]
Desmopressin Melt 10 μg57.360.056.563.575.6NANA
Desmopressin Melt 100 μg68.381.582.887.188.386.688.7
Desmopressin Melt 25 μg63.567.979.365.973.669.663.2
Desmopressin Melt 50 μg67.470.176.674.271.677.877.4

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Participants With Treatment-Emergent Adverse Events (AEs)

"An AE was any untoward medical occurrence that did not necessarily have a causal relationship with the study drug. An adverse drug reaction (ADR) was an AE evaluated by the Investigator as being probably or possibly causally related to treatment with the study drug.~A serious AE (SAE) was any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect or was an important medical event that could have jeopardized the patient's safety or required medical or surgical intervention to prevent 1 of the outcomes listed above. The intensity of an AE was defined as severe if it resulted in the inability to work or perform usual activities." (NCT00615836)
Timeframe: From first dose of study drug in Study CS29 until the end of study CS31 (up to 35 months).

,,,,
Interventionparticipants (Number)
All adverse eventsDeathsSerious adverse eventsAEs leading to discontinuationSevere adverse eventsAdverse drug reactions (ADRs)
Desmopressin Melt 10 μg14909142188
Desmopressin Melt 100 μg1900213125107
Desmopressin Melt 25 μg188222203687
Desmopressin Melt 50 μg1872293339100
Placebo81017252

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Change From Baseline in Total Sleep Time

"Participants completed a sleep diary on 3 consecutive mornings prior to each study visit, from which the total sleep time was calculated and averaged for the 3 days. Baseline refers to Baseline of Study CS29 and the number of weeks represents the total exposure to study drug.~Participants in the 10μg arm are included only until the time of dose escalation." (NCT00615836)
Timeframe: Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.

,,,
Interventionminutes (Mean)
8 Weeks [N=103, 96, 91, 104]12 Weeks [N=85, 81, 77, 81]20 Weeks [N=61, 58, 64, 64]28 Weeks [N=64, 85, 62, 62]52-56 Weeks [N=46, 91, 80, 77]72-76 Weeks [N=0, 80, 72, 66]92-96 Weeks [N=0, 67, 61, 62]
Desmopressin Melt 10 μg13.9320.6612.6411.1221.09NANA
Desmopressin Melt 100 μg14.6812.9024.5422.2515.8419.3426.83
Desmopressin Melt 25 μg19.7724.9436.1334.9920.8626.4423.45
Desmopressin Melt 50 μg33.1730.3434.0133.9925.6833.2237.33

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Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Physical Component Summary Score

"The SF-12v2 was used to measure the impact of nocturia and lack of sleep on general quality of life. The SF-12 consists of 12 questions spanning 8 domains: physical functioning, role function-physical, role function-emotional, bodily pain, general health, vitality, social functioning, and mental health. These scales are combined to create 2 summary measures: the Physical Health Summary and Mental Health Summary. The Physical Health Summary score ranges from 0 to 100, where higher numbers indicate better quality of life.~Participants in the 10μg arm are included only until the time of dose escalation." (NCT00615836)
Timeframe: Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)

,,,
Interventionunits on a scale (Mean)
Week 16 [N=34, 42, 44, 34]Visit 12 [N=0, 82, 73, 66]End of Study [N=17, 91, 81, 80]
Desmopressin Melt 10 μg1.23NA1.29
Desmopressin Melt 100 μg0.142.28-0.67
Desmopressin Melt 25 μg1.421.35-0.02
Desmopressin Melt 50 μg2.622.081.75

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Change From Baseline in Initial Period of Undisturbed Sleep

"Participants completed a sleep diary on 3 consecutive mornings prior to each study visit, from which the initial period of undisturbed sleep was calculated and averaged for the 3 days. The Initial Period of Undisturbed Sleep is the time elapsed from bedtime to either first void or morning arising minus the minutes it took to fall asleep. Baseline refers to Baseline of Study CS29 and the number of weeks represents the total exposure to study drug.~Participants in the 10μg arm are included only until the time of dose escalation." (NCT00615836)
Timeframe: Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.

,,,
Interventionminutes (Mean)
8 Weeks [N=93, 82, 83, 90]12 Weeks [N=78, 69, 66, 72]20 Weeks [N=55, 51, 59, 58]28 Weeks [N=59, 80, 58, 61]52-56 Weeks [N=42, 88, 75, 71]72-76 Weeks [N=0, 77, 68, 60]92-96 Weeks [N=0, 66, 56, 57]
Desmopressin Melt 10 μg77.6497.5794.51113.60120.91NANA
Desmopressin Melt 100 μg126.63144.77155.44143.86167.72200.67185.74
Desmopressin Melt 25 μg96.58116.70115.60116.46110.59125.21134.14
Desmopressin Melt 50 μg104.72118.71133.66101.04121.34137.91163.31

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AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)

Bioequivalence based on AUCinf (NCT00835211)
Timeframe: Blood samples collected over 12 hour period

Interventionpg*h/mL (Mean)
Desmopressin Acetate266.62
DDAVP®286.34

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AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)

Bioequivalence based on AUC0-t (NCT00835211)
Timeframe: Blood samples collected over 12 hour period

Interventionpg*h/mL (Mean)
Desmopressin Acetate252.85
DDAVP®268.02

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Cmax - Maximum Observed Concentration

Bioequivalence based on Cmax (NCT00835211)
Timeframe: Blood samples collected over 12 hour period

Interventionpg/mL (Mean)
Desmopressin Acetate78.102
DDAVP®82.888

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Mean Change From Baseline International Prostate Symptom Score (IPSS) Quality of Life Score at Week 12

The International Prostate Symptoms Score (IPSS) is a self-administered 8 item questionnaire designed to assess urination frequency and Quality of Life (QOL). The last question (item 8) concerns Quality of Life (QOL) and is scaled 0-6 where higher numbers indicate lower quality of life due to symptoms. Higher scores represent worse Quality of Life (QoL). (NCT00902265)
Timeframe: Baseline, Week 12

InterventionUnits on a scale (Mean)
Desmopressin 0.1 mg-1.56

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Mean Change From Baseline in Ratio of Nighttime Urine Volume to 24-hour Urine Volume at Week 12

The ratio of nighttime urine volume to 24-hour urine volume is calculated as the urine volume (volume of all voids after going to bed plus the first morning void) / 24-hour urine volume. Ratios are calculated at baseline and week 12 and difference between the two time points is reported here. (NCT00902265)
Timeframe: Baseline, Week 12

Interventionratio (Mean)
Desmopressin 0.1 mg-14.0

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Mean Change From Baseline in Total Score in Leeds Sleep Evaluation Questionnaire (LSEQ) at Week 12

The LSEQ is a self-administered 10-item visual analog scale questionnaire designed to assess sleep quality. The 10 individual items are scored 1 to 100, with the total score ranging from 0 - 1,000. Higher numbers indicate lower sleep quality. (NCT00902265)
Timeframe: Baseline, Week 12

InterventionUnits on a scale (Mean)
Desmopressin 0.1 mg-15.1

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Mean Change From Baseline in Initial Period of Undisturbed Sleep at Week 12

Initial period of undisturbed sleep is calculated as the number of hours between falling asleep and waking for the first time during the night to void. Change is calculated at Week 12 - baseline. (NCT00902265)
Timeframe: Baseline, Week 12

InterventionHours (Mean)
Desmopressin 0.1 mg1.69

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Mean Change From Baseline of Total International Prostate Symptom Score (IPSS) at Week 12

The International Prostate Symptoms Score (IPSS) is a self-administered 8 item questionnaire designed to assess urination frequency and Quality of Life (QOL). The first 7 items are summed into a total score and question urination frequency. They are scaled 0-5, with higher numbers indicating greater severity of symptoms. The last question (item 8) concerns QOL and is scaled 0-6 where higher numbers indicate lower quality of life due to symptoms. The total scale across all questions is 0-41, with higher scores representing worse symptoms. (NCT00902265)
Timeframe: Baseline, Week 12

InterventionUnits on a scale (Mean)
Desmopressin 0.1 mg-4.86

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Overall Mean Change From Baseline in Mean Number of Nighttime Voids at Week 12

The number of nighttime voids was calculated over 48-hours period prior to baseline and week 12 visits. Calculated as Week 12 measure - Baseline measure. (NCT00902265)
Timeframe: Baseline, Week 12

InterventionNumber of nocturnal voids (Mean)
Desmopressin 0.1 mg-2.01

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Participants With Treatment Emergent Adverse Events (AEs)

(NCT00902265)
Timeframe: Week 1 to Week 12

InterventionParticipants (Number)
All Adverse EventsDeathsSerious Adverse EventsAEs Leading to Discontinuation
Desmopressin 0.1 mg3002

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Change From Baseline in Degree of Bother Due to Frequency of Daytime Voiding Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N)

The ICIQ-N is a self-administered 4-item questionnaire designed to assess the frequency and bother of daytime and nighttime urination. In questions 1 and 2 participants were asked to estimate the frequency of both daytime voiding (all voids before going to bed excluding the first morning void) and rate the degree of bother of daytime urination on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate lower Quality of Life (QoL). (NCT00902265)
Timeframe: Baseline, Week 12

InterventionUnits on a scale (Mean)
Desmopressin 0.1 mg-2.25

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Change From Baseline in Degree of Bother Due to Frequency of Nighttime Voiding Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N)at Week 12

The ICIQ-N is a self-administered 4-item questionnaire designed to assess the frequency and bother of daytime and nighttime urination. In questions 3 and 4, participants were asked to estimate the frequency of nighttime voiding (number of voids after going to bed plus the first morning void) and rate the degree of bother of nighttime urination on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate lower Quality of Life (QOL). (NCT00902265)
Timeframe: Baseline, Week 12

InterventionUnits on a scale (Mean)
Desmopressin 0.1 mg-4.00

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Adverse Events : New Fever >=100.4F, Respiratory Distress or Pulmonary Edema on Chest Radiography, Rash, Hypotension (Systolic BP < 100 mm Hg or New Vasopressor Use or Increase in Vasopressor Dose by >25%)

We prospectively defined acute adverse events as: new fever >=100.4F, respiratory distress or pulmonary edema on chest radiography, rash, hypotension (systolic BP < 100 mm Hg or new vasopressor use or increase in vasopressor dose by >25%). The two patients reported were the only two that sustained any of the prospectively defined adverse events. (NCT00961532)
Timeframe: within 6 hours of study treatment

Interventionparticipants (Number)
DDAVP2

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Change in Platelet Activity, Measured in Seconds on PFA-EPI Assay, From Pre to Post-treatment

The Platelet Function Analyzer (PFA) is a commercially available point-of-care assay that measures the time to closure of an aperature. Longer time to closure indicates less platelet activity. EPI denotes epinephrine (as opposed to adenosine diphosphate) as the stimulant to platelet aggregation. In our laboratory, a time to closure of at least 172 seconds in consistent with an aspirin effect. (NCT00961532)
Timeframe: 60 minutes after treatment start

Interventionseconds (Mean)
DDAVP68

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Change in Number of Wet Nights Between Baseline and Treatment Period I

The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Baseline Period minus the number of wet nights during the 14-day Treatment Period I. (NCT01078753)
Timeframe: Baseline (14-day period prior to starting study treatment) and Treatment Period I (weeks 1-2 after treatment initiation).

Interventionwet nights (Least Squares Mean)
Desmopressin2.946
Placebo1.317

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Change in Number of Wet Nights Between Treatment Periods I and II

The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Treatment Period I minus the number of wet nights during the 14-day Treatment Period II. (NCT01078753)
Timeframe: Treatment Period I (weeks 1-2) and Treatment Period II (weeks 3-4)

Interventionwet nights (Least Squares Mean)
Desmopressin0.318
Placebo0.135

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Change in the Number of Wet Nights Between Baseline and Treatment Period II

The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Baseline Period minus the number of wet nights during the 14-day Treatment Period II. (NCT01078753)
Timeframe: Baseline (14-day period prior to starting study treatment) and Treatment Period II (weeks 3-4 after treatment initiation).

Interventionwet nights (Least Squares Mean)
Desmopressin3.264
Placebo1.451

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Time When Urine Production <0.12 ml/kg/Min

Urine volume was registered and samples for osmolality check were collected every 30 minutes as long as there was an antidiuretic action defined as a urine production <0.12 mL/kg/min. The hydration due to water-loading should have lasted until end of action, defined as when the urine production returned to >0.12 mL/kg/min, but no longer than 12 hours. (NCT01184859)
Timeframe: Day 1

Interventionhours (Mean)
Placebo0.41
Desmopressin 10µg1.67
Desmopressin 25µg3.50
Desmopressin 50µg6.05
Desmopressin 100µg8.20

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Duration of Action Defined as the Time With Urine Osmolality Above 200 mOsm/kg - Period 1

Participants were water-loaded to suppress the endogenous release of vasopressin, thus all antidiuretic activity was generated by desmopressin only. Water-loading was initiated 2 hours before dosing on Day 1. Urine volume was registered and samples for osmolality check were collected every 30 minutes as long as there was an antidiuretic action defined as a urine production <0.12 mL/kg/min. The hydration should have lasted until end of action, defined as when the urine production returned to >0.12 mL/kg/min, but no longer than 12 hours. (NCT01184859)
Timeframe: Day 1

Interventionhours (Mean)
Placebo0.00
Desmopressin 10µg0.09
Desmopressin 25µg2.00
Desmopressin 50µg3.45
Desmopressin 100µg5.74

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Change From Baseline in Total Sleep Time at Approximately Day 32

"Total sleep time is defined as the time spent asleep from initial sleep to final awakening.~Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average of the total time asleep of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings." (NCT01184859)
Timeframe: 3 days between study days -6 to 0 (Baseline), and days 25 to 32

Interventionminutes (Mean)
Placebo2.47
Desmopressin 10µg-11.86
Desmopressin 25µg-33.04
Desmopressin 50µg6.81
Desmopressin 100µg14.07

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Change From Baseline in Number of Nocturnal Voids After 28 Days of Treatment - Period 2

Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average number of nocturnal voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings. (NCT01184859)
Timeframe: 3 days between study days -6 to 0 (Baseline), and days 25 to 32

Interventionnocturnal voids (Least Squares Mean)
Placebo-0.735
Desmopressin 10µg-1.007
Desmopressin 25µg-1.282
Desmopressin 50µg-1.589
Desmopressin 100µg-1.624

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Change From Baseline in Number of 24-hour Urine Voids at Approximately Day 32

Number of voids in 24 hours was recorded over three consecutive days per week in diaries kept by study participants. The average number of 24-hour voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings. (NCT01184859)
Timeframe: 3 days between study days -6 to 0 (Baseline), and days 25 to 32

Interventionvoids (Mean)
Placebo-0.15
Desmopressin 10µg-0.47
Desmopressin 25µg-1.19
Desmopressin 50µg-1.33
Desmopressin 100µg-0.96

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Change From Baseline in Nocturnal Urine Volume at Approximately Day 32

Nocturnal urine volume was recorded over three consecutive days per week in diaries kept by study participants. The average nocturnal urine volume of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings. (NCT01184859)
Timeframe: 3 days between study days -6 to 0 (Baseline), and days 25 to 32

Interventionml (Mean)
Placebo-114.70
Desmopressin 10µg-140.68
Desmopressin 25µg-209.87
Desmopressin 50µg-295.02
Desmopressin 100µg-333.22

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Area Under the Urine Osmolality Curve (AUCosm)

Area under the urine osmolality curve, from dose administration to end of action (AUCosm). (NCT01184859)
Timeframe: Day 1

Interventionh*mOsm/kg (Mean)
Placebo0.00
Desmopressin 10µg24.67
Desmopressin 25µg852.00
Desmopressin 50µg1551.01
Desmopressin 100µg3112.53

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Change From Baseline in Number of Daytime Voids at Approximately Day 32

Number of daytime voids was recorded over three consecutive days per week in diaries kept by study participants. The average number of daytime voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings. (NCT01184859)
Timeframe: 3 days between study days -6 to 0 (Baseline), and days 25 to 32

Interventionvoids (Mean)
Placebo0.49
Desmopressin 10µg0.68
Desmopressin 25µg0.15
Desmopressin 50µg0.23
Desmopressin 100µg0.63

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Change From Baseline in 24-Hour Urine Production Per Body Weight at Approximately Day 32

Twenty-four hour urine volume was recorded over three consecutive days per week in diaries kept by study participants. Urine volume per body weight was calculated. The average 24-hour urine volume per kg of body weight of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings. (NCT01184859)
Timeframe: 3 days between study days -6 to 0 (Baseline), and days 25 to 32

Interventionml/kg (Mean)
Placebo-2.017
Desmopressin 10µg-0.096
Desmopressin 25µg-3.523
Desmopressin 50µg-4.573
Desmopressin 100µg-3.058

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Change From Baseline in Nocturnal Polyuria Index at Approximately Day 32

Nocturnal polyuria index is defined as a proportion of nocturnal urine volume to the 24-hour urine volume. Urine volume and time of day of those voids was recorded over three consecutive days per week in diaries kept by study participants. The average nocturnal polyuria index of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings. (NCT01184859)
Timeframe: 3 days between study days -6 to 0 (Baseline), and days 25 to 32

Interventionnocturnal urine volume / 24-hour urine (Mean)
Placebo-4.72
Desmopressin 10µg-7.82
Desmopressin 25µg-8.61
Desmopressin 50µg-13.56
Desmopressin 100µg-16.00

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Change From Baseline in 24-Hour Urine Volume at Approximately Day 32

Twenty-four hour urine volume was recorded over three consecutive days per week in diaries kept by study participants. The average 24-hour urine volume of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings. (NCT01184859)
Timeframe: 3 days between study days -6 to 0 (Baseline), and days 25 to 32

Interventionml (Mean)
Placebo-104.47
Desmopressin 10µg-19.47
Desmopressin 25µg-201.83
Desmopressin 50µg-270.53
Desmopressin 100µg-187.25

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Change From Baseline in Duration of First Period of Undisturbed Sleep After 28 Days of Treatment - Period 2

"Duration of first period of undisturbed sleep is defined as the length of time from initial sleep to first awakening.~Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average length of first period of undisturbed sleep of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings." (NCT01184859)
Timeframe: 3 days between study days -6 to 0 (Baseline), and days 25 to 32

Interventionminutes (Mean)
Placebo68.39
Desmopressin 10µg101.85
Desmopressin 25µg113.45
Desmopressin 50µg190.77
Desmopressin 100µg194.25

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Participant Counts of Minimum Observed Serum Sodium Levels During the Second Treatment Period (Days 4-32)

Serum sodium levels were monitored throughout the trial as part of the clinical chemistry panel. If the value was ≤125 mEq/L, the participant was to be withdrawn from the trial and treatment stopped immediately. This outcome reports participants' lowest recorded serum sodium levels during the second treatment period. (NCT01184859)
Timeframe: Days 4- 32

,,,,
Interventionparticipants (Number)
>= 135 mEq/L>=130 mEq/L to <135 mEq/L<130 mEq/L
Desmopressin 100µg2300
Desmopressin 10µg2300
Desmopressin 25µg2110
Desmopressin 50µg2110
Placebo2300

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Area Under the Urine Production Curve (AUCurine Prod)

Area under the urine production curve, from dose administration to end of action (AUCurine prod) (NCT01184859)
Timeframe: Day 1

Interventionh*mL (Mean)
Placebo59.34
Desmopressin 10µg214.24
Desmopressin 25µg297.17
Desmopressin 50µg522.99
Desmopressin 100µg537.08

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Minimum Post-Treatment Serum Sodium Levels

Serum sodium levels were monitored since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. The serum sodium level must have been within the normal reference range at the Screening Visit for the participant to be eligible for enrollment. A participant was to be withdrawn from the trial if the serum sodium level was <=125 mmol/L at any time. (NCT01223937)
Timeframe: Day 1 up to 3 months

,
Interventionparticipants (Number)
<=125 mmol/L126-129 mmol/L130-134 mmol/L>=135 mmol/L
Desmopressin 25 μg0311121
Placebo002124

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Summary of Participants With Treatment-Emergent Adverse Events (TEAEs)

A TEAE was any adverse event occurring after start of treatment and within the time of residual drug effect, i.e., within 1 day of the last dose of desmopressin. An adverse drug reaction (ADR) was any AE assessed by the Investigator as possibly/probably related to study drug. (NCT01223937)
Timeframe: Day 1 up to 3 months

,
Interventionparticipants (Number)
All adverse events (AEs)Severe AEsAdverse drug reactions (ADRs)AEs leading to discontinuationADRs leading to discontinuationSerious AEsDeaths
Desmopressin 25 μg601264300
Placebo573151020

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Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period

"The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during-treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void. Change from baseline values for Week 1, and Months 1, 2 and 3 are reported below.~Comparison of the mean number of nocturnal voids at baseline and over a 3-month treatment period (obtained by longitudinal analysis of Week 1, and Months 1, 2 and 3) are reported in the statistical analysis. This was the first co-primary endpoint. The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary endpoints." (NCT01223937)
Timeframe: Day 1 (Baseline); Week 1, Months 1, 2, 3 (3-month treatment period)

,
Interventionnocturnal voids (Mean)
Week 1 (n=124, 128)Month 1 (n=121, 126)Month 2 (n=116, 121)Month 3 (n=107, 113)
Desmopressin 25 μg-1.21-1.47-1.57-1.69
Placebo-1-1.25-1.36-1.38

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Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids at Month 3

"Probability of participants achieving 33% responder status at Month 3 employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the Month 3 visit as recorded in participant diaries. The first morning void was not counted as a nocturnal void.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed." (NCT01223937)
Timeframe: Day 1 (Baseline), Month 3

Interventionprobability (Number)
Placebo0.69
Desmopressin 25 μg0.79

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Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids for All During-Treatment Visits up to Month 3

"Probability of participants achieving 33% responder status during 3 months of treatment employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void.~This was the second co-primary endpoint. The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary endpoints." (NCT01223937)
Timeframe: Day 1 (Baseline); Week 1, Months 1, 2, 3 (3-month treatment period)

Interventionprobability (Number)
Placebo0.64
Desmopressin 25 μg0.76

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Change From Baseline in 24-Hour Urine Volume at Month 3

"Twenty-four hour urine volume was derived from the 3-day urine volume diary. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed." (NCT01223937)
Timeframe: Day 1 (Baseline), Month 3

InterventionmL (Mean)
Placebo-152
Desmopressin 25 μg-255

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Change From Baseline in Mean Number of Nocturnal Voids at Month 3

"The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during-treatment visits (Month 3 for this outcome) as recorded in participant diaries. The first morning void was not counted as a nocturnal void.~Secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed." (NCT01223937)
Timeframe: Day 1 (Baseline), Month 3

Interventionnocturnal voids (Mean)
Placebo-1.38
Desmopressin 25 μg-1.69

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Change From Baseline in Mean Time to First Nocturnal Void at Month 3

"The time to first void was defined as the time from going to bed with the intention of sleeping until first nocturnal void or until waking in the morning in cases where there was no nocturnal void. The time to first void was derived from the sleep and voiding diary. The mean time to first void was calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed." (NCT01223937)
Timeframe: Day 1 (Baseline), Month 3

Interventionminutes (Mean)
Placebo115
Desmopressin 25 μg168

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Change From Baseline in Nocturnal Urine Volume at Month 3

"The nocturnal urine volume was derived from the 3-day urine volume diary. The nocturnal urine volume included the volume of the first morning void. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed." (NCT01223937)
Timeframe: Day 1 (Baseline), Month 3

InterventionmL (Mean)
Placebo-151
Desmopressin 25 μg-242

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Change From Baseline in Mean Number of Nocturnal Voids at Month 3

"Comparison of the mean number of nocturnal voids at baseline and at the 3-month visit. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to the relevant visits as recorded in participant diaries. The first morning void was not counted as a nocturnal void.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)." (NCT01262456)
Timeframe: Day 1 (Baseline), Month 3

Interventionnocturnal voids (Mean)
Desmopressin 75 μg Double-Blind-1.37
Desmopressin 50 μg Double-Blind-1.25
Placebo Double-Blind-0.984

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Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Period

A TEAE was any adverse event (AE) occurring after start of treatment and within the time of residual drug effect, i.e., within 1 day for desmopressin. An adverse drug reaction (ADR) was any AE assessed by the investigator as possibly or probably related to study drug. (NCT01262456)
Timeframe: From Day 1 through Month 3 (double-blind period)

,,
Interventionparticipants (Number)
All AEsSevere AEsAdverse drug reactions (ADRs)AEs leading to discontinuationADRs leading to discontinuationSerious AEs (SAEs)Deaths
Desmopressin 50 μg Double-Blind462234440
Desmopressin 75 μg Double-Blind492207550
Placebo Double-Blind582227410

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Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids at Month 3

"Probability of participants achieving 33% responder status at Month 3 employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the Month 3 visit as recorded in participant diaries. The first morning void was not counted as a nocturnal void.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)." (NCT01262456)
Timeframe: Day 1 (Baseline), Month 3

Interventionprobability (Number)
Desmopressin 75 μg Double-Blind0.68
Desmopressin 50 μg Double-Blind0.66
Placebo Double-Blind0.54

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Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids for All During-Treatment Visits up to Month 3

"Probability of participants achieving 33% responder status during 3 months of treatment employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void.~This was the second co-primary outcome. Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary endpoints in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level." (NCT01262456)
Timeframe: Day 1 (Baseline), Week 1, Months 1, 2, 3 (3-month double-blind treatment period)

Interventionprobability (Number)
Desmopressin 75 μg Double-Blind0.67
Desmopressin 50 μg Double-Blind0.67
Placebo Double-Blind0.50

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Change From Baseline in 24-Hour Urine Volume at Month 3

"Twenty-four hour urine volume was derived from the 3-day urine volume diary. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)." (NCT01262456)
Timeframe: Day 1 (Baseline), Month 3

InterventionmL (Mean)
Desmopressin 75 μg Double-Blind-224
Desmopressin 50 μg Double-Blind-194
Placebo Double-Blind-197

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Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Period

A TEAE was any adverse event (AE) occurring after start of treatment and within the time of residual drug effect, i.e., within 1 day for desmopressin. An adverse drug reaction (ADR) was any AE assessed by the investigator as possibly or probably related to study drug. (NCT01262456)
Timeframe: Month 1 of open-label period (Month 4 of treatment)

,,
Interventionparticipants (Number)
All AEsSevere AEsAdverse drug reactions (ADRs)AEs leading to discontinuationADRs leading to discontinuationSerious AEs (SAEs)Deaths
Desmopressin 50 μg Double-Blind / 100 μg Open-Label23060000
Desmopressin 75 μg Double-Blind / 100 μg Open-Label23192210
Placebo Double-Blind / Desmopressin 100 μg Open-Label26092220

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Change From Baseline in Mean Time to First Nocturnal Void at Month 3

"The time to first void was defined as the time from going to bed with the intention of sleeping until first nocturnal void or until waking in the morning in the case where there was no nocturnal void. The first morning void was not counted as a nocturnal void. The time to first void was derived from the sleep and voiding diary. The mean time to first void was calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)." (NCT01262456)
Timeframe: Day 1 (Baseline), Month 3

Interventionminutes (Mean)
Desmopressin 75 μg Double-Blind117
Desmopressin 50 μg Double-Blind113
Placebo Double-Blind71.5

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Change From Baseline in Nocturnal Urine Volume at Month 3

"The nocturnal urine volume was derived from the 3-day urine volume diary. The nocturnal urine volume included the volume of the first morning void. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)." (NCT01262456)
Timeframe: Day 1 (Baseline), Month 3

InterventionmL (Mean)
Desmopressin 75 μg Double-Blind-199
Desmopressin 50 μg Double-Blind-186
Placebo Double-Blind-144

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Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period

"The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during-treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void. Change from baseline values for Week 1, and Months 1, 2 and 3 are reported below.~Comparison of the mean number of nocturnal voids at baseline and over a 3-month treatment period (obtained by longitudinal analysis of Week 1, and Months 1, 2 and 3) are reported in the statistical analysis. This was the first co-primary outcome. Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary outcomes in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level." (NCT01262456)
Timeframe: Day 1 (Baseline), Week 1, Months 1, 2, 3 (3-month double-blind treatment period)

,,
Interventionnocturnal voids (Mean)
Week 1 (n=120, 116, 141)Month 1 (n=117, 112, 139)Month 2 (n=113, 107, 132)Month 3 (n=106, 103, 125)
Desmopressin 50 μg Double-Blind-0.973-1.31-1.4-1.25
Desmopressin 75 μg Double-Blind-1.06-1.4-1.43-1.37
Placebo Double-Blind-0.591-0.928-1.01-0.984

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Minimum Post-Treatment Serum Sodium Levels in the Double-Blind Period

Serum sodium levels were monitored at each study visit since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. The serum sodium level must have been within the normal reference range at the Screening Visit for the participant to be eligible for enrollment. A participant was to be withdrawn from the trial if the serum sodium level was <=125 mmol/L at any time. (NCT01262456)
Timeframe: Day 1 through Month 3 (double-blind period)

,,
Interventionparticipants (Number)
≤125 mmol/L126-129 mmol/L130-134 mmol/L≥135 mmol/L
Desmopressin 50 μg Double-Blind209108
Desmopressin 75 μg Double-Blind4512101
Placebo Double-Blind002141

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Minimum Post-Treatment Serum Sodium Levels in the Open-Label Period

Serum sodium levels were monitored at each study visit since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. The serum sodium level must have been within the normal reference range at the Screening Visit for the participant to be eligible for enrollment. A participant was to be withdrawn from the trial if the serum sodium level was <=125 mmol/L at any time. (NCT01262456)
Timeframe: Month 1 of open-label period (Month 4 of treatment)

,,
Interventionparticipants (Number)
≤125 mmol/L126-129 mmol/L130-134 mmol/L≥135 mmol/L
Desmopressin 50 μg Double-Blind / 100 μg Open-Label011288
Desmopressin 75 μg Double-Blind / 100 μg Open-Label111189
Placebo Double-Blind / Desmopressin 100 μg Open-Label1310110

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Cohen's D Effect Size in Responsiveness in the Nocturia Impact (NI) Total Scores and Overall Impact Question as Measured From Baseline (Day 1) to Month 1

"The responsiveness of the NI Diary was measured with Cohen's D effect size. The effect size was calculated for active treatment versus placebo, based on change from Baseline to Month 1. The effect size was evaluated as small, medium, or large if D was <=0.35, >0.35 - 0.65, or >0.65, respectively.~Mean values are the Cohen's D effect size. Standard deviation is the pooled standard deviation." (NCT01552343)
Timeframe: Day 1 (Baseline), Month 1

Interventionunits on a scale (Mean)
Nocturia Impact (NI) Total Score (Q1-Q11)Overall Impact Question (Q12)
All Participants0.73-0.00

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Change From Baseline to Month 1 on Nocturia Impact (NI) Total Score

The NI Diary is a 12-item instrument consisting of 11 core items and an overall impact question (Q12). Responses are scored from 0 (no impact) to 4 (highest impact); the NI total score is the sum of the 11 core items scores (range of 0-44) which is then transformed to a 0-100 scale (high score indicates high impact). The NI total score was analyzable only if all 11 items (Q1-Q11) had non-missing responses. Otherwise, it was defined as missing. Missing values were not imputed. The average over the 3-day diary period prior to baseline (Day 1) and Month 1 was used for the overall impact score. Negative change from baseline scores indicate a decrease in impact caused by nocturia. (NCT01552343)
Timeframe: Baseline (Day -2 to Day 1), Treatment (Day 28-30)

Interventionunits on a scale (Mean)
Desmopressin-8.5
Placebo-9.64

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Construct Validity For the Nocturia Impact (NI) Total Scores and Overall Impact Question (Q12) for Participants With High/Low Number of Nocturnal Voids

"The known group validity was assessed by comparing participants who experienced ≥3 nocturnal voids to those who experienced <3 nocturnal voids, using the average over 3 days for the Screening and Baseline diaries. Results are reported for the NI Total Scores and the Overall Impact Question (Q12).~The NI Diary is a 12-item instrument consisting of 11 core items and an overall impact question (Q12). The NI total score is defined as the sum of the 11 core items scores.~The overall impact question (Q12) and the NI total score were transformed using Fisher's z transformation, i.e. the scores were based on a standardized scale from 0 (lowest impact) to 100 (highest impact)." (NCT01552343)
Timeframe: Screening (Day -20), Baseline (Day 1)

,
Interventionunits on a scale (Mean)
Nocturia Impact (NI) Total Score: ScreeningNocturia Impact (NI) Total Score: BaselineOverall Impact Question (Q12): ScreeningOverall Impact Question (Q12): Baseline
< 3 Voids28.125.740.435.6
>= 3 Voids36.739.356.253.3

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Difference in Mean Change From Baseline to Month 1 in Nocturia Impact (NI) Total Scores and Overall Impact Question for Responders and Non-Responders

"This outcome is a measure of sensitivity of the NI Diary to change in nocturia.~The NI Diary is a 12-item instrument consisting of 11 core items and an overall impact question (Q12). The NI total score is defined as the sum of the 11 core items scores.~The overall impact question (Q12) and the NI total score were transformed using Fisher's z transformation, i.e. the scores were based on a standardized scale from 0 (lowest impact) to 100 (highest impact).~The difference in mean change in NI total score for subjects who experienced a reduction from baseline of <33% in nocturnal voids at the Month 1 visit (non-responders) versus those with a reduction in nocturnal voids from Baseline of ≥33% (responders) was estimated." (NCT01552343)
Timeframe: Day 1 (Baseline), Month 1

,
Interventionunits on a scale (Mean)
Nocturia Impact (NI) Total Score (Q1-Q11)Overall Impact Question (Q12)
Non-Responders-2.6-4.9
Responders-13.3-4.9

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Internal Consistency of the Nocturia Impact (NI) Total Score for Each Day NI Diaries Were Completed Assessed as Cronbach's Alpha Values

"Cronbach's alpha (CA) is a measure of the internal consistency of the Nocturia Impact (NI) Total scores. Higher scores indicate a more reliable (precise) instrument. A value of 0.70 set as the benchmark for declaring the scale as internally consistent.~Cronbach's alpha was assessed for each of the three consecutive days NI diaries were completed during screening (Day -20 to Day -18), baseline (Day -2 to Day 1) and Month 1 (Day 28 to Day 30)." (NCT01552343)
Timeframe: Screening (Day -20 to Day -18), Baseline (Day -2 to Day 1) and Treatment (Day 28 to Day 30)

Interventionratio of variance (Number)
Screening Day -20Screening Day -19Screening Day -18Baseline Day -2Baseline Day -1Baseline Day 1Treatment Day 28Treatment Day 29Treatment Day 30
All Participants0.9150.9250.9230.9390.9410.9430.9200.9140.898

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Minimum Post-Treatment Serum Sodium Levels

Serum sodium levels were monitored since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. A participant was to be withdrawn from the trial if the serum sodium level was <=125 mmol/L at any time. (NCT01552343)
Timeframe: Day 1 up to 1 month

,,,
Interventionparticipants (Number)
<=125 mmol/L>125 - <130 mmol/L>=130 - 135 mmol/L
Female - Desmopressin 25 μg002
Female - Placebo000
Male - Desmopressin 75 μg001
Male - Placebo000

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Summary of Participants With Treatment-Emergent Adverse Events (TEAEs)

A TEAE was any adverse event occurring after start of treatment and within the time of residual drug effect, i.e. within one day of the last dose of desmopressin. (NCT01552343)
Timeframe: Day 1 up to 1 month

,,,
Interventionparticipants (Number)
All adverse events (AEs)DeathsSerious AEsAEs leading to discontinuationSevere AEsAdverse drug reactions (ADRs)
Female - Desmopressin 25 μg200001
Female - Placebo200000
Male - Desmopressin 75 μg000000
Male - Placebo100000

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The Pearson Correlation Coefficient Between Change From Baseline to Month 1 in Number of Nocturnal Voids and Change From Baseline to Month 1 in Nocturia Impact (NI) Diary Total Score

"This outcome is a measure of sensitivity of the NI Diary to change in nocturia.~The NI Diary is a 12-item instrument consisting of 11 core items and an overall impact question (Q12). Responses are scored from 0 (no impact) to 4 (highest impact); a lowering of score equals a decrease in impact caused by nocturia. The NI total score is the sum of the 11 core items scores. The NI total score was analyzable only if all 11 items (Q1-Q11) had non-missing responses. Otherwise, it was defined as missing. Missing values were not imputed. The average over the 3-day diary period prior to baseline (Day 1) and Month 1 was used for the overall impact score.~The correlation was estimated using Fisher's z transformation, i.e. the NI total score was based on a standardized scale from 0 (lowest impact) to 100 (highest impact).~Corresponding adjusted partial correlation coefficients were based on adjustments for mean number of Baseline voids, Baseline NI total score, age, and gender." (NCT01552343)
Timeframe: Day 1 (Baseline), Month 1

Interventioncorrelation coefficient (Number)
Correlation - no adjustmentsAdjusted partial correlation - baseline # of voidsAdj partial correlation - baseline NI total scoreAdjusted partial correlation - age categoryAdjusted partial correlation - gender
All Participants0.310.350.280.330.33

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Change in Mean Number of Nocturnal Voids From Baseline

A nocturnal void was defined as a void occurring at least 5 minutes after going to bed, but before getting up the next morning. The mean estimate was the average over 3 consecutive 24-hour periods prior to the respective visit as captured in the voiding and sleep diary. (NCT01729819)
Timeframe: Baseline to 3 months of treatment

InterventionVoids (Least Squares Mean)
Combination-1.63
Tolterodine-1.29

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Change in Mean Time to First Nocturnal Void From Baseline

The time to first nocturnal void was defined as the time from going to bed with the intention of sleeping until first nocturnal void or until waking in the morning in the case there is no nocturnal void. The time to first void was calculated as the average over three consecutive 24-hour periods prior to the respective visits. (NCT01729819)
Timeframe: Baseline to 3 months of treatment

InterventionMinutes (Least Squares Mean)
Combination118.19
Tolterodine100.19

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Responder Status

Responder status was defined as ≥33% decrease in the mean number of nocturnal void and at least one night with no voids out of the 3-day diary period. (NCT01729819)
Timeframe: Baseline to 3 months of treatment

InterventionProportion of responders (Number)
Combination0.40
Tolterodine0.29

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Change in the Impact on Sleep as Measured by the Sleep Rating Scales From Baseline

An electronic diary was used in the trial to document the impact on sleep quality (sleep rating scales). The sleep rating scales included three questions that ranged from 0 (poor) to 10 (good). The average of each question for each visit was summarised and the change from baseline was analysed longitudinally during the three months of treatment. (NCT01729819)
Timeframe: Baseline to 3 months of treatment

,
InterventionScore on scale (Least Squares Mean)
From very tired to wide awake, how do you feel nowRate how refreshed you feel nowRate the quality of your sleep last night
Combination1.761.811.95
Tolterodine1.331.461.67

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Onset of Effect as Seen in Change in Mean Number of Nocturnal Voids From Baseline for Each Visit During Three Months of Treatment

A nocturnal void was defined as a void occurring at least 5 minutes after going to bed, but before getting up the next morning. The mean estimate was the average over 3 consecutive 24-hour periods prior to the respective visit as captured in the voiding and sleep diary. (NCT01729819)
Timeframe: Baseline to 3 months of treatment

InterventionVoids (Least Squares Mean)
Month 1Month 2Month 3Overall (during the three months)
Treatment Difference (Combination-tolterodine)-0.19-0.44-0.43-0.35

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Change in Mean Nocturnal Urine Volume From Baseline

The mean nocturnal urine volume was derived from the three-day urine volume diary. The nocturnal volume was defined as the sum of the volumes for all nocturnal voids including the volume of the first morning void within 30 min of waking up in the morning. (NCT01729819)
Timeframe: Baseline to 3 months of treatment

InterventionmL (Least Squares Mean)
Combination-156.6
Tolterodine-92.46

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Change From Baseline in PGI-S Scores at Week 8

"The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe).~Change from baseline in visit-specific PGI-S is presented in this endpoint.~Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint." (NCT03201419)
Timeframe: Baseline, Week 8

Interventionscore on a scale (Least Squares Mean)
FE 201836 500 ug (Randomized Treatment Period)-1.132
FE 201836 350 ug (Randomized Treatment Period)-1.410
FE 201836 250 ug (Randomized Treatment Period)-0.825
FE 201836 150 ug (Randomized Treatment Period)-0.643
FE 201836 100 ug (Randomized Treatment Period)-0.816
FE 201836 50 ug (Randomized Treatment Period)-1.013
Placebo (Randomized Treatment Period)-0.800

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Change From Baseline in PGI-S Scores at Week 4

"The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe).~Change from baseline in visit-specific PGI-S is presented in this endpoint.~Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint." (NCT03201419)
Timeframe: Baseline, Week 4

Interventionscore on a scale (Least Squares Mean)
FE 201836 500 ug (Randomized Treatment Period)-0.837
FE 201836 350 ug (Randomized Treatment Period)-1.025
FE 201836 250 ug (Randomized Treatment Period)-0.798
FE 201836 150 ug (Randomized Treatment Period)-0.749
FE 201836 100 ug (Randomized Treatment Period)-0.656
FE 201836 50 ug (Randomized Treatment Period)-0.936
Placebo (Randomized Treatment Period)-0.898

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Change From Baseline in PGI-S Scores at Week 12

"The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe).~Change from baseline in visit-specific PGI-S is presented in this endpoint.~Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint." (NCT03201419)
Timeframe: Baseline, Week 12

Interventionscore on a scale (Least Squares Mean)
FE 201836 500 ug (Randomized Treatment Period)-1.181
FE 201836 350 ug (Randomized Treatment Period)-1.338
FE 201836 250 ug (Randomized Treatment Period)-0.894
FE 201836 150 ug (Randomized Treatment Period)-0.638
FE 201836 100 ug (Randomized Treatment Period)-1.168
FE 201836 50 ug (Randomized Treatment Period)-1.041
Placebo (Randomized Treatment Period)-0.853

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Change From Baseline in Patient Global Impression of Severity (PGI-S) Scores at Week 1

"The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe).~Change from baseline in visit-specific PGI-S is presented in this endpoint.~Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint." (NCT03201419)
Timeframe: Baseline, Week 1

Interventionscore on a scale (Least Squares Mean)
FE 201836 500 ug (Randomized Treatment Period)-0.739
FE 201836 350 ug (Randomized Treatment Period)-0.970
FE 201836 250 ug (Randomized Treatment Period)-0.811
FE 201836 150 ug (Randomized Treatment Period)-0.643
FE 201836 100 ug (Randomized Treatment Period)-0.417
FE 201836 50 ug (Randomized Treatment Period)-0.719
Placebo (Randomized Treatment Period)-0.593

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Change From Baseline in Nocturnal Diuresis Rate Profiles at Week 12

"The nocturnal diuresis rate (mL/min) is calculated as the mean of the nocturnal diuresis for each of the three nights, with the single-night nocturnal diuresis calculated as the ratio of NUV to total time in bed.~Change from baseline in visit-specific mean nocturnal diuresis (mL/min) is presented.~Level estimated for baseline value of mean nocturnal diuresis (mL/min) equal to 1.3 is presented in this endpoint." (NCT03201419)
Timeframe: Baseline, Week 12

InterventionmL/min (Mean)
FE 201836 500 ug (Randomized Treatment Period)-0.648
FE 201836 350 ug (Randomized Treatment Period)-0.606
FE 201836 250 ug (Randomized Treatment Period)-0.735
FE 201836 150 ug (Randomized Treatment Period)-0.458
FE 201836 100 ug (Randomized Treatment Period)-0.685
FE 201836 50 ug (Randomized Treatment Period)-0.651
Placebo (Randomized Treatment Period)-0.515

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Change From Baseline in Nocturnal Diuresis Rate Profiles at Week 1

"The nocturnal diuresis rate (mL/min) is calculated as the mean of the nocturnal diuresis for each of the three nights, with the single-night nocturnal diuresis calculated as the ratio of NUV to total time in bed.~Change from baseline in visit-specific mean nocturnal diuresis (mL/min) is presented.~Level estimated for baseline value of mean nocturnal diuresis (mL/min) equal to 1.3 is presented in this endpoint." (NCT03201419)
Timeframe: Baseline, Week 1

InterventionmL/min (Mean)
FE 201836 500 ug (Randomized Treatment Period)-0.575
FE 201836 350 ug (Randomized Treatment Period)-0.635
FE 201836 250 ug (Randomized Treatment Period)-0.610
FE 201836 150 ug (Randomized Treatment Period)-0.459
FE 201836 100 ug (Randomized Treatment Period)-0.523
FE 201836 50 ug (Randomized Treatment Period)-0.328
Placebo (Randomized Treatment Period)-0.402

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Change From Baseline in Mean NUV in Week 1

"The NUV is defined as the total urine volume from 5 minutes after bedtime with the intention to sleep including the first void within 30 minutes of rising in the morning.~The NUV at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NUV are estimated using a baseline value of 750 (mL)." (NCT03201419)
Timeframe: Baseline, Week 1

InterventionmL (Mean)
FE 201836 500 ug (Randomized Treatment Period)-328.8
FE 201836 350 ug (Randomized Treatment Period)-371.8
FE 201836 250 ug (Randomized Treatment Period)-352.4
FE 201836 150 ug (Randomized Treatment Period)-265.5
FE 201836 100 ug (Randomized Treatment Period)-312.6
FE 201836 50 ug (Randomized Treatment Period)-218.2
Placebo (Randomized Treatment Period)-241.6

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Change From Baseline in Mean NUV at Week 12

"The NUV is defined as the total urine volume from 5 minutes after bedtime with the intention to sleep including the first void within 30 minutes of rising in the morning.~The NUV at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NUV are estimated using a baseline value of 750 (mL)." (NCT03201419)
Timeframe: Baseline, Week 12

InterventionmL (Mean)
FE 201836 500 ug (Randomized Treatment Period)-367.3
FE 201836 350 ug (Randomized Treatment Period)-392.4
FE 201836 250 ug (Randomized Treatment Period)-411.3
FE 201836 150 ug (Randomized Treatment Period)-284.2
FE 201836 100 ug (Randomized Treatment Period)-393.5
FE 201836 50 ug (Randomized Treatment Period)-403.2
Placebo (Randomized Treatment Period)-317.8

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Change From Baseline in Mean Number of Nocturnal Voids at Week 8

"Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning.~The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2." (NCT03201419)
Timeframe: Baseline, Week 8

Interventionnocturnal voids (Mean)
FE 201836 500 ug (Randomized Treatment Period)-1.085
FE 201836 350 ug (Randomized Treatment Period)-1.177
FE 201836 250 ug (Randomized Treatment Period)-0.965
FE 201836 150 ug (Randomized Treatment Period)-0.490
FE 201836 100 ug (Randomized Treatment Period)-1.077
FE 201836 50 ug (Randomized Treatment Period)-0.786
Placebo (Randomized Treatment Period)-0.953

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Change From Baseline in Mean Number of Nocturnal Voids at Week 4

"Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning.~The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2." (NCT03201419)
Timeframe: Baseline, Week 4

Interventionnocturnal voids (Mean)
FE 201836 500 ug (Randomized Treatment Period)-1.078
FE 201836 350 ug (Randomized Treatment Period)-1.330
FE 201836 250 ug (Randomized Treatment Period)-0.784
FE 201836 150 ug (Randomized Treatment Period)-0.471
FE 201836 100 ug (Randomized Treatment Period)-0.952
FE 201836 50 ug (Randomized Treatment Period)-0.518
Placebo (Randomized Treatment Period)-0.912

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Change From Baseline in Aggregated Mean Duration of FUSP During 12 Weeks of Treatment

"The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred.~The visit-specific means were aggregated into a mean of current and preceding visits.~Level estimated for baseline value of mean duration of FUSP (minutes) equal to 180 is presented in this endpoint.~The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint." (NCT03201419)
Timeframe: Baseline, During 12 Weeks of Treatment

Interventionminutes (Mean)
FE 201836 500 ug (Randomized Treatment Period)154.98
FE 201836 350 ug (Randomized Treatment Period)150.23
FE 201836 250 ug (Randomized Treatment Period)145.95
FE 201836 150 ug (Randomized Treatment Period)140.74
FE 201836 100 ug (Randomized Treatment Period)139.19
FE 201836 50 ug (Randomized Treatment Period)138.13
Placebo (Randomized Treatment Period)137.45

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Change From Baseline in Mean Number of Nocturnal Voids at Week 1

"Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning.~The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2.~MMRM=Mixed Model for Repeated Measurements.~For all visit-specific results, the tables present the number of subjects with an observation of the endpoints in question at the specific visit. All secondary analyses are performed using the observed-case approach based on repeated measurements for all subjects in the ITT-RT population. That is, these secondary analyses are based on all subjects with at least one non-missing post-baseline observation (with a baseline value if relevant)." (NCT03201419)
Timeframe: Baseline, Week 1

Interventionnocturnal voids (Mean)
FE 201836 500 ug (Randomized Treatment Period)-0.714
FE 201836 350 ug (Randomized Treatment Period)-1.162
FE 201836 250 ug (Randomized Treatment Period)-0.722
FE 201836 150 ug (Randomized Treatment Period)-0.520
FE 201836 100 ug (Randomized Treatment Period)-0.722
FE 201836 50 ug (Randomized Treatment Period)-0.325
Placebo (Randomized Treatment Period)-0.575

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Change From Baseline in Mean NI Diary Total Score at Week 8

"The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact).~The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40." (NCT03201419)
Timeframe: Baseline, Week 8

Interventionscore on a scale (Mean)
FE 201836 500 ug (Randomized Treatment Period)-16.03
FE 201836 350 ug (Randomized Treatment Period)-23.22
FE 201836 250 ug (Randomized Treatment Period)-15.10
FE 201836 150 ug (Randomized Treatment Period)-12.04
FE 201836 100 ug (Randomized Treatment Period)-19.23
FE 201836 50 ug (Randomized Treatment Period)-14.11
Placebo (Randomized Treatment Period)-14.83

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Change From Baseline in Mean NI Diary Total Score at Week 4

"The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact).~The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40." (NCT03201419)
Timeframe: Baseline, Week 4

Interventionscore on a scale (Mean)
FE 201836 500 ug (Randomized Treatment Period)-12.62
FE 201836 350 ug (Randomized Treatment Period)-17.44
FE 201836 250 ug (Randomized Treatment Period)-14.37
FE 201836 150 ug (Randomized Treatment Period)-11.23
FE 201836 100 ug (Randomized Treatment Period)-22.23
FE 201836 50 ug (Randomized Treatment Period)-13.29
Placebo (Randomized Treatment Period)-14.20

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Change From Baseline in Mean NI Diary Total Score at Week 12

"The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact).~The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40." (NCT03201419)
Timeframe: Baseline, Week 12

Interventionscore on a scale (Mean)
FE 201836 500 ug (Randomized Treatment Period)-16.92
FE 201836 350 ug (Randomized Treatment Period)-24.44
FE 201836 250 ug (Randomized Treatment Period)-14.68
FE 201836 150 ug (Randomized Treatment Period)-10.13
FE 201836 100 ug (Randomized Treatment Period)-22.59
FE 201836 50 ug (Randomized Treatment Period)-17.18
Placebo (Randomized Treatment Period)-17.45

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Change From Baseline in Mean NI Diary Total Score at Week 1

"The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall quality of life (QoL) impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items.Responses are scored from 0 to 4 (lowest t o highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact).~The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40." (NCT03201419)
Timeframe: Baseline, Week 1

Interventionscore on a scale (Mean)
FE 201836 500 ug (Randomized Treatment Period)-7.55
FE 201836 350 ug (Randomized Treatment Period)-21.91
FE 201836 250 ug (Randomized Treatment Period)-10.90
FE 201836 150 ug (Randomized Treatment Period)-8.93
FE 201836 100 ug (Randomized Treatment Period)-9.68
FE 201836 50 ug (Randomized Treatment Period)-8.75
Placebo (Randomized Treatment Period)-8.07

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Change From Baseline in Mean NI Diary Overall Impact Score at Week 8

"The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact).~The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40." (NCT03201419)
Timeframe: Baseline, Week 8

Interventionscore on a scale (Mean)
FE 201836 500 ug (Randomized Treatment Period)-28.13
FE 201836 350 ug (Randomized Treatment Period)-34.97
FE 201836 250 ug (Randomized Treatment Period)-21.71
FE 201836 150 ug (Randomized Treatment Period)-19.03
FE 201836 100 ug (Randomized Treatment Period)-23.84
FE 201836 50 ug (Randomized Treatment Period)-20.70
Placebo (Randomized Treatment Period)-25.32

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Change From Baseline in Mean NI Diary Overall Impact Score at Week 12

"The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact).~The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40." (NCT03201419)
Timeframe: Baseline, Week 12

Interventionscore on a scale (Mean)
FE 201836 500 ug (Randomized Treatment Period)-30.47
FE 201836 350 ug (Randomized Treatment Period)-36.76
FE 201836 250 ug (Randomized Treatment Period)-20.84
FE 201836 150 ug (Randomized Treatment Period)-15.32
FE 201836 100 ug (Randomized Treatment Period)-28.89
FE 201836 50 ug (Randomized Treatment Period)-27.13
Placebo (Randomized Treatment Period)-30.03

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Change From Baseline in Mean NI Diary Overall Impact Score at Week 1

"The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact).~The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40." (NCT03201419)
Timeframe: Baseline, Week 1

Interventionscore on a scale (Mean)
FE 201836 500 ug (Randomized Treatment Period)-10.98
FE 201836 350 ug (Randomized Treatment Period)-30.39
FE 201836 250 ug (Randomized Treatment Period)-15.51
FE 201836 150 ug (Randomized Treatment Period)-11.77
FE 201836 100 ug (Randomized Treatment Period)-2.79
FE 201836 50 ug (Randomized Treatment Period)-12.26
Placebo (Randomized Treatment Period)-13.46

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Change From Baseline in Mean Duration of FUSP at Week 8

"The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred.~The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min)." (NCT03201419)
Timeframe: Baseline, Week 8

Interventionminutes (Mean)
FE 201836 500 ug (Randomized Treatment Period)160.4
FE 201836 350 ug (Randomized Treatment Period)225.4
FE 201836 250 ug (Randomized Treatment Period)190.2
FE 201836 150 ug (Randomized Treatment Period)136.8
FE 201836 100 ug (Randomized Treatment Period)163.2
FE 201836 50 ug (Randomized Treatment Period)164.3
Placebo (Randomized Treatment Period)161.0

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Change From Baseline in Mean Duration of FUSP at Week 4

"The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred.~The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min)." (NCT03201419)
Timeframe: Baseline, Week 4

Interventionminutes (Mean)
FE 201836 500 ug (Randomized Treatment Period)164.5
FE 201836 350 ug (Randomized Treatment Period)211.0
FE 201836 250 ug (Randomized Treatment Period)132.3
FE 201836 150 ug (Randomized Treatment Period)89.5
FE 201836 100 ug (Randomized Treatment Period)122.0
FE 201836 50 ug (Randomized Treatment Period)95.5
Placebo (Randomized Treatment Period)150.2

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Change From Baseline in Mean Duration of FUSP at Week 12

"The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred.~The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min)." (NCT03201419)
Timeframe: Baseline, Week 12

Interventionminutes (Mean)
FE 201836 500 ug (Randomized Treatment Period)178.5
FE 201836 350 ug (Randomized Treatment Period)160.0
FE 201836 250 ug (Randomized Treatment Period)180.7
FE 201836 150 ug (Randomized Treatment Period)111.5
FE 201836 100 ug (Randomized Treatment Period)141.1
FE 201836 50 ug (Randomized Treatment Period)166.2
Placebo (Randomized Treatment Period)162.8

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Change From Baseline in Mean Duration of First Undisturbed Sleep Period (FUSP) at Week 1

"The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occured.~The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min)." (NCT03201419)
Timeframe: Baseline, Week 1

Interventionminutes (Mean)
FE 201836 500 ug (Randomized Treatment Period)122.9
FE 201836 350 ug (Randomized Treatment Period)187.0
FE 201836 250 ug (Randomized Treatment Period)106.0
FE 201836 150 ug (Randomized Treatment Period)91.7
FE 201836 100 ug (Randomized Treatment Period)82.9
FE 201836 50 ug (Randomized Treatment Period)51.3
Placebo (Randomized Treatment Period)81.1

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Change From Baseline in ISI at Week 8

"The ISI is a 7-item questionnaire which comprises of four 'sleep-related' items and three 'wake-related' items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28 (higher score suggests more severe insomnia).~Change from baseline in visit-specific ISI is presented in this endpoint.~Level estimated for baseline value of ISI equal to 15 is presented in this endpoint." (NCT03201419)
Timeframe: Baseline, Week 8

Interventionscore on a scale (Least Squares Mean)
FE 201836 500 ug (Randomized Treatment Period)-7.643
FE 201836 350 ug (Randomized Treatment Period)-8.091
FE 201836 250 ug (Randomized Treatment Period)-6.693
FE 201836 150 ug (Randomized Treatment Period)-6.959
FE 201836 100 ug (Randomized Treatment Period)-5.707
FE 201836 50 ug (Randomized Treatment Period)-7.167
Placebo (Randomized Treatment Period)-6.408

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Change From Baseline in ISI at Week 4

"The ISI is a 7-item questionnaire which comprises of four 'sleep-related' items and three 'wake-related' items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28 (higher score suggests more severe insomnia).~Change from baseline in visit-specific ISI is presented in this endpoint.~Level estimated for baseline value of ISI equal to 15 is presented in this endpoint." (NCT03201419)
Timeframe: Baseline, Week 4

Interventionscore on a scale (Least Squares Mean)
FE 201836 500 ug (Randomized Treatment Period)-6.589
FE 201836 350 ug (Randomized Treatment Period)-6.652
FE 201836 250 ug (Randomized Treatment Period)-5.630
FE 201836 150 ug (Randomized Treatment Period)-5.428
FE 201836 100 ug (Randomized Treatment Period)-4.510
FE 201836 50 ug (Randomized Treatment Period)-6.372
Placebo (Randomized Treatment Period)-5.277

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Change From Baseline in ISI at Week 12

"The ISI is a 7-item questionnaire which comprises of four 'sleep-related' items and three 'wake-related' items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28 (higher score suggests more severe insomnia).~Change from baseline in visit-specific ISI is presented in this endpoint.~Level estimated for baseline value of ISI equal to 15 is presented in this endpoint." (NCT03201419)
Timeframe: Baseline, Week 12

Interventionscore on a scale (Least Squares Mean)
FE 201836 500 ug (Randomized Treatment Period)-7.807
FE 201836 350 ug (Randomized Treatment Period)-9.329
FE 201836 250 ug (Randomized Treatment Period)-6.355
FE 201836 150 ug (Randomized Treatment Period)-6.193
FE 201836 100 ug (Randomized Treatment Period)-5.002
FE 201836 50 ug (Randomized Treatment Period)-7.908
Placebo (Randomized Treatment Period)-6.678

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Change From Baseline in Hsu 5-point Likert Bother Scale at Week 8

"The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely).~Change from baseline in visit-specific Hsu Bother is presented in this endpoint.~Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint." (NCT03201419)
Timeframe: Baseline, Week 8

Interventionscore on a scale (Least Squares Mean)
FE 201836 500 ug (Randomized Treatment Period)-0.972
FE 201836 350 ug (Randomized Treatment Period)-1.044
FE 201836 250 ug (Randomized Treatment Period)-0.991
FE 201836 150 ug (Randomized Treatment Period)-0.499
FE 201836 100 ug (Randomized Treatment Period)-1.012
FE 201836 50 ug (Randomized Treatment Period)-0.881
Placebo (Randomized Treatment Period)-0.731

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Change From Baseline in Aggregated Mean NI Diary Overall Impact Score During 12 Weeks of Treatment

"The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact).~The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. The visit-specific means were aggregated into a mean of current and preceding visits.~Level estimated for baseline value of mean NI Diary Overall Impact Score equal to 40 is presented in this endpoint.~The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint." (NCT03201419)
Timeframe: Baseline, during 12 weeks of treatment

Interventionscore on a scale (Mean)
FE 201836 500 ug (Randomized Treatment Period)-6.50
FE 201836 350 ug (Randomized Treatment Period)-6.25
FE 201836 250 ug (Randomized Treatment Period)-6.11
FE 201836 150 ug (Randomized Treatment Period)-6.00
FE 201836 100 ug (Randomized Treatment Period)-5.98
FE 201836 50 ug (Randomized Treatment Period)-5.97
Placebo (Randomized Treatment Period)-5.96

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Change From Baseline in Mean NI Diary Overall Impact Score at Week 4

"The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact).~The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40." (NCT03201419)
Timeframe: Baseline, Week 4

Interventionscore on a scale (Mean)
FE 201836 500 ug (Randomized Treatment Period)-22.17
FE 201836 350 ug (Randomized Treatment Period)-26.07
FE 201836 250 ug (Randomized Treatment Period)-19.35
FE 201836 150 ug (Randomized Treatment Period)-18.36
FE 201836 100 ug (Randomized Treatment Period)-17.95
FE 201836 50 ug (Randomized Treatment Period)-21.40
Placebo (Randomized Treatment Period)-21.75

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Change From Baseline in Aggregated Mean NI Diary Total Score During 12 Weeks of Treatment

"The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact).~The score at each visit was calculated as the mean over the three consecutive 24 hour periods just prior to the respective visit. The visit-specific means were aggregated into a mean of current and preceding visits.~Level estimated for baseline value of mean NI Diary Total Score equal to 40 is presented in this endpoint.~The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint." (NCT03201419)
Timeframe: Baseline, during 12 weeks of treatment

Interventionscore on a scale (Median)
FE 201836 500 ug (Randomized Treatment Period)-12.40
FE 201836 350 ug (Randomized Treatment Period)-12.69
FE 201836 250 ug (Randomized Treatment Period)-12.75
FE 201836 150 ug (Randomized Treatment Period)-12.77
FE 201836 100 ug (Randomized Treatment Period)-12.77
FE 201836 50 ug (Randomized Treatment Period)-12.78
Placebo (Randomized Treatment Period)-12.77

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Responder Rate in Nocturnal Voids During 12 Weeks of Treatment

"Defined as 50% reduction in nocturnal voids from baseline.~Estimated odds of at least 50% reduction in the aggregated mean number of nocturnal voids for a subject with 2 nocturnal voids at baseline are presented in this endpoint.~The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint.~The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%)." (NCT03201419)
Timeframe: During 12 weeks of treatment

Interventionodd of response (Mean)
FE 201836 500 ug (Randomized Treatment Period)1.129
FE 201836 350 ug (Randomized Treatment Period)1.095
FE 201836 250 ug (Randomized Treatment Period)1.032
FE 201836 150 ug (Randomized Treatment Period)0.934
FE 201836 100 ug (Randomized Treatment Period)0.887
FE 201836 50 ug (Randomized Treatment Period)0.849
Placebo (Randomized Treatment Period)0.834

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Responder Rate in Nocturnal Voids at Week 8

"Defined as 50% reduction in nocturnal voids from baseline.~Adjusted visit-specific estimated odds of at least 50% reduction in the mean number of nocturnal voids are estimated using a baseline value of 2.~The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%)." (NCT03201419)
Timeframe: Week 8

Interventionodd of response (Mean)
FE 201836 500 ug (Randomized Treatment Period)1.395
FE 201836 350 ug (Randomized Treatment Period)3.398
FE 201836 250 ug (Randomized Treatment Period)1.928
FE 201836 150 ug (Randomized Treatment Period)0.877
FE 201836 100 ug (Randomized Treatment Period)1.039
FE 201836 50 ug (Randomized Treatment Period)1.489
Placebo (Randomized Treatment Period)1.503

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Responder Rate in Nocturnal Voids at Week 4

"Defined as 50% reduction in nocturnal voids from baseline.~Adjusted visit-specific estimated odds of at least 50% reduction in the mean number of nocturnal voids are estimated using a baseline value of 2.~The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%)." (NCT03201419)
Timeframe: Week 4

Interventionodd of response (Mean)
FE 201836 500 ug (Randomized Treatment Period)1.199
FE 201836 350 ug (Randomized Treatment Period)5.851
FE 201836 250 ug (Randomized Treatment Period)0.634
FE 201836 150 ug (Randomized Treatment Period)0.534
FE 201836 100 ug (Randomized Treatment Period)1.760
FE 201836 50 ug (Randomized Treatment Period)0.683
Placebo (Randomized Treatment Period)1.235

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Responder Rate in Nocturnal Voids at Week 12

"Defined as 50% reduction in nocturnal voids from baseline.~Adjusted visit-specific estimated odds of at least 50% reduction in the mean number of nocturnal voids are estimated using a baseline value of 2.~The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%)." (NCT03201419)
Timeframe: Week 12

Interventionodd of response (Mean)
FE 201836 500 ug (Randomized Treatment Period)3.914
FE 201836 350 ug (Randomized Treatment Period)1.891
FE 201836 250 ug (Randomized Treatment Period)1.824
FE 201836 150 ug (Randomized Treatment Period)0.854
FE 201836 100 ug (Randomized Treatment Period)1.400
FE 201836 50 ug (Randomized Treatment Period)1.395
Placebo (Randomized Treatment Period)1.590

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Responder Rate in Nocturnal Voids at Week 1

"Defined as 50% reduction in nocturnal voids from baseline.~Adjusted visit-specific estimated odds of at least 50% in the reduction mean number of nocturnal voids are estimated using a baseline value of 2.~The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%)." (NCT03201419)
Timeframe: Week 1

Interventionodd of response (Mean)
FE 201836 500 ug (Randomized Treatment Period)0.844
FE 201836 350 ug (Randomized Treatment Period)1.202
FE 201836 250 ug (Randomized Treatment Period)0.682
FE 201836 150 ug (Randomized Treatment Period)0.818
FE 201836 100 ug (Randomized Treatment Period)0.810
FE 201836 50 ug (Randomized Treatment Period)0.513
Placebo (Randomized Treatment Period)0.480

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Change From Baseline in Hsu 5-point Likert Bother Scale at Week 4

"The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely).~Change from baseline in visit-specific Hsu Bother is presented in this endpoint.~Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint." (NCT03201419)
Timeframe: Baseline, Week 4

Interventionscore on a scale (Least Squares Mean)
FE 201836 500 ug (Randomized Treatment Period)-0.896
FE 201836 350 ug (Randomized Treatment Period)-0.940
FE 201836 250 ug (Randomized Treatment Period)-0.712
FE 201836 150 ug (Randomized Treatment Period)-0.606
FE 201836 100 ug (Randomized Treatment Period)-1.096
FE 201836 50 ug (Randomized Treatment Period)-0.861
Placebo (Randomized Treatment Period)-0.665

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Change From Baseline in Hsu 5-point Likert Bother Scale at Week 12

"The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely).~Change from baseline in visit-specific Hsu Bother is presented in this endpoint.~Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint." (NCT03201419)
Timeframe: Baseline, Week 12

Interventionscore on a scale (Least Squares Mean)
FE 201836 500 ug (Randomized Treatment Period)-0.992
FE 201836 350 ug (Randomized Treatment Period)-1.249
FE 201836 250 ug (Randomized Treatment Period)-0.700
FE 201836 150 ug (Randomized Treatment Period)-0.880
FE 201836 100 ug (Randomized Treatment Period)-0.974
FE 201836 50 ug (Randomized Treatment Period)-0.921
Placebo (Randomized Treatment Period)-0.769

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Change From Baseline in Mean Number of Nocturnal Voids at Week 12

"Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning.~The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2." (NCT03201419)
Timeframe: Baseline, Week 12

Interventionnocturnal voids (Mean)
FE 201836 500 ug (Randomized Treatment Period)-1.256
FE 201836 350 ug (Randomized Treatment Period)-1.120
FE 201836 250 ug (Randomized Treatment Period)-0.850
FE 201836 150 ug (Randomized Treatment Period)-0.674
FE 201836 100 ug (Randomized Treatment Period)-1.053
FE 201836 50 ug (Randomized Treatment Period)-0.921
Placebo (Randomized Treatment Period)-0.957

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Percentage of Nights With at Most One Nocturnal Void During 12 Weeks of Treatment

"The percentages of nights during the treatment period with at most one nocturnal void are presented in this endpoint.~Level estimated for baseline value of mean number of nocturnal voids equal to 2 is presented in this endpoint." (NCT03201419)
Timeframe: During 12 weeks of treatment

Interventionpercentage of nights (Mean)
FE 201836 500 ug (Randomized Treatment Period)67.2
FE 201836 350 ug (Randomized Treatment Period)77.5
FE 201836 250 ug (Randomized Treatment Period)64.5
FE 201836 150 ug (Randomized Treatment Period)55.3
FE 201836 100 ug (Randomized Treatment Period)73.2
FE 201836 50 ug (Randomized Treatment Period)61.4
Placebo (Randomized Treatment Period)62.0

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Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 8

"The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse).~Visit-specific PGI-I in urinary symptoms is presented in this endpoint." (NCT03201419)
Timeframe: Week 8

Interventionscore on a scale (Mean)
FE 201836 500 ug (Randomized Treatment Period)1.843
FE 201836 350 ug (Randomized Treatment Period)1.887
FE 201836 250 ug (Randomized Treatment Period)2.528
FE 201836 150 ug (Randomized Treatment Period)2.286
FE 201836 100 ug (Randomized Treatment Period)2.155
FE 201836 50 ug (Randomized Treatment Period)2.273
Placebo (Randomized Treatment Period)2.573

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Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 4

"The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse).~Visit-specific PGI-I in urinary symptoms is presented in this endpoint." (NCT03201419)
Timeframe: Week 4

Interventionscore on a scale (Mean)
FE 201836 500 ug (Randomized Treatment Period)2.121
FE 201836 350 ug (Randomized Treatment Period)2.191
FE 201836 250 ug (Randomized Treatment Period)2.447
FE 201836 150 ug (Randomized Treatment Period)2.521
FE 201836 100 ug (Randomized Treatment Period)2.385
FE 201836 50 ug (Randomized Treatment Period)2.582
Placebo (Randomized Treatment Period)2.596

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Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 12

"The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse).~Visit-specific PGI-I in urinary symptoms is presented in this endpoint." (NCT03201419)
Timeframe: Week 12

Interventionscore on a scale (Mean)
FE 201836 500 ug (Randomized Treatment Period)1.667
FE 201836 350 ug (Randomized Treatment Period)1.671
FE 201836 250 ug (Randomized Treatment Period)2.656
FE 201836 150 ug (Randomized Treatment Period)2.452
FE 201836 100 ug (Randomized Treatment Period)1.678
FE 201836 50 ug (Randomized Treatment Period)2.384
Placebo (Randomized Treatment Period)2.490

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Percentage of Nights With No Nocturnal Voids During 12 Weeks of Treatment

"The percentages of nights during the treatment period with complete response, i.e. no nocturnal voids are presented in this endpoint.~Level estimated for baseline value of mean number of nocturnal voids equal to 2 is presented in this endpoint." (NCT03201419)
Timeframe: During 12 weeks of treatment

Interventionpercentage of nights (Mean)
FE 201836 500 ug (Randomized Treatment Period)23.3
FE 201836 350 ug (Randomized Treatment Period)28.8
FE 201836 250 ug (Randomized Treatment Period)17.3
FE 201836 150 ug (Randomized Treatment Period)12.9
FE 201836 100 ug (Randomized Treatment Period)14.8
FE 201836 50 ug (Randomized Treatment Period)21.5
Placebo (Randomized Treatment Period)23.0

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Change From Baseline in Hsu 5-point Likert Bother Scale at Week 1

"The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely).~Change from baseline in visit-specific Hsu Bother is presented in this endpoint.~Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint." (NCT03201419)
Timeframe: Baseline, Week 1

Interventionscore on a scale (Least Squares Mean)
FE 201836 500 ug (Randomized Treatment Period)-0.649
FE 201836 350 ug (Randomized Treatment Period)-1.072
FE 201836 250 ug (Randomized Treatment Period)-0.748
FE 201836 150 ug (Randomized Treatment Period)-0.458
FE 201836 100 ug (Randomized Treatment Period)-0.346
FE 201836 50 ug (Randomized Treatment Period)-0.376
Placebo (Randomized Treatment Period)-0.570

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Change From Baseline in Aggregated Mean Number of Nocturnal Voids During 12 Weeks of Treatment

"Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning.~The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. The visit-specific means were aggregated into a mean of current and preceding visits.~Level estimated for baseline value of mean number of nocturnal voids equal to 2, and 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval are presented in this endpoint." (NCT03201419)
Timeframe: Baseline, during 12 weeks of treatment

Interventionnocturnal voids (Mean)
FE 201836 500 ug (Randomized Treatment Period)-1.06
FE 201836 350 ug (Randomized Treatment Period)-0.99
FE 201836 250 ug (Randomized Treatment Period)-0.89
FE 201836 150 ug (Randomized Treatment Period)-0.80
FE 201836 100 ug (Randomized Treatment Period)-0.77
FE 201836 50 ug (Randomized Treatment Period)-0.76
Placebo (Randomized Treatment Period)-0.76

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Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 1

"The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse).~Visit-specific PGI-I in urinary symptoms is presented in this endpoint." (NCT03201419)
Timeframe: Week 1

Interventionscore on a scale (Mean)
FE 201836 500 ug (Randomized Treatment Period)2.475
FE 201836 350 ug (Randomized Treatment Period)2.045
FE 201836 250 ug (Randomized Treatment Period)2.708
FE 201836 150 ug (Randomized Treatment Period)2.786
FE 201836 100 ug (Randomized Treatment Period)2.781
FE 201836 50 ug (Randomized Treatment Period)2.758
Placebo (Randomized Treatment Period)2.745

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