Page last updated: 2024-12-08

lubiprostone

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Cross-References

ID SourceID
PubMed CID157920
CHEMBL ID1201134
SCHEMBL ID217184
MeSH IDM0493211

Synonyms (64)

Synonym
AC-1863
spi-0211
amitiza
amitiza (tn)
D04790
lubiprostone (jan/usan/inn)
333963-40-9
ru-0211
lubiprostone ,
DB01046
(-)-7-((2r,4ar,5r,7ar)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta(b)pyran-5-yl)heptanoic acid
lubiprostone [usan]
CHEMBL1201134
7-[(2r,4ar,5r,7ar)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxo-3,4,4a,5,7,7a-hexahydrocyclopenta[b]pyran-5-yl]heptanoic acid
7-[(2r,4ar,5s,7ar)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxo-3,4,4a,5,7,7a-hexahydrocyclopenta[b]pyran-5-yl]heptanoic acid
cas-136790-76-6
dtxcid2028565
tox21_112986
dtxsid5048639 ,
7662kg2r6k ,
prostan-1-oic acid, 11,15-epoxy-16,16-difluoro-15-hydroxy-9-oxo-, (11alpha,15r)-
bicyclic lubiprostone
lubiprostone hemiketal
AKOS015896639
(2r,4ar,5r,7ar)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxo-3,4,4a,5,7,7a-hexahydrocyclopenta[b]pyran-5-heptanoic acid
7-[(2r,4ar,5r,7ar)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxo-3,4,4a,5,7,7a-hexahydrocyclopenta[e]pyran-5-yl]heptanoic acid
gtpl4242
SCHEMBL217184
lubiprostone [jan]
lubiprostone [orange book]
7-[(2r,4ar,5r,7ar)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta[b]pyran-5-yl]heptanoic acid
prostan-1-oic acid, 16,16-difluoro-11-hydroxy-9,15-dioxo-, (11.alpha.)-
lubiprostone [mi]
lubiprostone [vandf]
lubiprostone [inn]
lubiprostone [mart.]
lubiprostone [who-dd]
7-((2r,4ar,5r,7ar)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta[b]pyran-5-yl)heptanoic acid
mfcd20268389
7-((2r,4ar,5r,7ar)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta[b]pyran-5-yl)heptanoicacid
J-006909
EX-A1771
333963-40-9 (hemiketal)
cas# 333963-40-9
Z2037281137
AS-39360
Q6695342
7-[(1r,3r,6r,7r)-3-(1,1-difluoropentyl)-3-hydroxy-8-oxo-2-oxabicyclo[4.3.0]non-7-yl]heptanoic acid
NCGC00183105-02
AMY30093
A905955
A850935
7-[(2r,4ar,5r,7ar)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxo-octahydrocyclopenta[b]pyran-5-yl]heptanoic acid
EN300-657178
DTXSID80861338
lubiprostone (hemiketal)
CS-0009583
lubiprostone powder
lubiprostona
lubiprostonum
a06ax03
amitza
7-((2r,4ar,5r,7ar)-2-(1,1-difluoropentan-1-yl)-2-hydroxy-6-oxooctahydrocyclopenta(b)pyran-5-yl)heptanoic acid
lubiprostone (mart.)

Research Excerpts

Overview

Lubiprostone (LBP) is a novel chloride channel opener that has been reported to activate chloride channel protein 2 (ClC-2) and cystic fibrosis transmembrane conductance regulator (CFTR) It is an effective drug for various types of constipation in patients without cancer. There is no report on its efficacy and safety in patients with cancer.

ExcerptReferenceRelevance
"Lubiprostone (LBP) is a novel chloride channel opener that has been reported to activate chloride channel protein 2 (ClC-2) and cystic fibrosis transmembrane conductance regulator (CFTR). "( Negative chronotropic and inotropic effects of lubiprostone on iPS cell-derived cardiomyocytes via activation of CFTR.
Akita, H; Hazama, A; Ishida, T; Takeishi, Y; Yoshie, S, 2020
)
2.26
"Lubiprostone is an effective treatment of chronic constipation (CC). "( Risk Factors for Adverse Events in Patients with Chronic Constipation Following Lubiprostone Administration.
Eguchi, T; Hashimura, H; Ikeoka, S; Matsuda, T; Matsumoto, M; Miura, T; Momose, K; Morisawa, T; Okada, A; Okamoto, N; Otsuka, T; Takagi, M; Yoshizaki, T, 2021
)
2.29
"Lubiprostone is a type-2 chloride channel activator approved for treating chronic idiopathic constipation (CIC), opioid-induced constipation (OIC), and constipation-predominant irritable bowel syndrome in women."( Effects of Lubiprostone, an Intestinal Secretagogue, on Electrolyte Homeostasis in Chronic Idiopathic and Opioid-induced Constipation.
Habibi, S; Lichtlen, P; Rao, SSC, 2021
)
1.73
"Lubiprostone is an effective drug for various types of constipation in patients without cancer; however, there is no report on its efficacy and safety in patients with cancer. "( The Efficacy and Safety of Lubiprostone for Constipation in Cancer Patients Compared with Non-cancer Patients: A Retrospective Cohort Study.
Esumi, S; Kajizono, M; Kitamura, Y; Sada, H; Sendo, T; Ushio, S, 2020
)
2.3
"Lubiprostone is a type 2 chloride channel activator that has been shown to be efficacious and safe in the treatment for chronic constipation."( Systematic review with meta-analysis: lubiprostone efficacy on the treatment of patients with constipation.
Corradino, GC; Guedes, LS; Passos, MDCF; Takemoto, MLS,
)
1.85
"Lubiprostone is a locally acting chloride channel activator that promotes fluid secretion into the small bowel without affecting serum electrolyte concentrations."( Safety of Lubiprostone in Pediatric Patients With Functional Constipation: A Nonrandomized, Open-Label Trial.
Clifford, R; Hussain, SZ; Labrum, B; Mareya, S; Stripling, S, 2021
)
1.75
"Lubiprostone is an apical type 2 chloride channel activator approved for the treatment of chronic constipation (CC), and nausea is the most common adverse symptom. "( Evaluation of efficacy and safety of lubiprostone in patients with chronic constipation.
Fukushima, S; Handa, O; Handa, Y; Matsumoto, H; Murao, T; Osawa, M; Shiotani, A; Umegaki, E; Yo, S, 2021
)
2.34
"Lubiprostone is a ClC-2 chloride channel activator approved for the treatment of chronic idiopathic constipation (CIC) and opioid-induced constipation (OIC) in adults and irritable bowel syndrome with constipation (IBS-C) in women. "( Analysis of Nausea in Clinical Studies of Lubiprostone for the Treatment of Constipation Disorders.
Chey, WD; Cryer, B; Drossman, DA; Habibi, S; Wang, M; Webster, L, 2017
)
2.16
"Lubiprostone is a novel laxative that sometimes causes nausea, but preventive strategies remain unconfirmed."( Possible Effect of Concomitant Prokinetics and Herbal Medicines against Nausea in Patients Taking Lubiprostone.
Abe, K; Aoyagi, H; Isono, A; Kita, H; Osumi, S; Yamamoto, T; Yamato, H; Yanagisawa, D, 2017
)
2.11
"Lubiprostone is a safe and efficacious drug for treating chronic constipation."( Effect of Lubiprostone on Urinary Protein Excretion: A Report of Two IgA Nephropathy Patients with Chronic Constipation.
Nakamura, T; Node, K; Sato, E; Takeshita, M; Tanaka, A, 2019
)
1.64
"Lubiprostone is an intestinal type-2 chloride channel activator that increases intestinal fluid secretion, small intestinal transit, and stool passage."( A critical appraisal of lubiprostone in the treatment of chronic constipation in the elderly.
Cremonini, F; Gras-Miralles, B, 2013
)
1.42
"Lubiprostone is an oral chloride channel protein-2 activator that stimulates gastrointestinal fluid secretion, softens stools, and facilitates bowel movements (BMs)."( Lubiprostone for the treatment of functional constipation in children.
Di Lorenzo, C; Hyman, PE; Prestridge, LL; Ueno, R; Youssef, NN, 2014
)
2.57
"Lubiprostone is an activator of the type 2 chloride channel that facilitates spontaneous bowel movement (SBM). "( Lubiprostone increases spontaneous bowel movement frequency and quality of life in patients with chronic idiopathic constipation.
Fukudo, S; Hongo, M; Kaneko, H; Takano, M; Ueno, R, 2015
)
3.3
"Lubiprostone is a locally acting chloride channel (CIC-2) activator that increases secretions and peristalsis."( Novel Oral Therapies for Opioid-induced Bowel Dysfunction in Patients with Chronic Noncancer Pain.
Holder, RM; Rhee, D, 2016
)
1.16
"Lubiprostone is a safe and efficacious drug for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation, with limited adverse effects in 3 months of follow-up."( Lubiprostone Is Effective in the Treatment of Chronic Idiopathic Constipation and Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Fu, T; Gao, Y; Li, CX; Li, F; Liu, BH; Tong, WD; Wang, XF; Wu, JS; Zhang, AP, 2016
)
3.32
"Lubiprostone is an effective treatment for chronic constipation (CC). "( Lubiprostone Accelerates Intestinal Transit and Alleviates Small Intestinal Bacterial Overgrowth in Patients With Chronic Constipation.
Alvarez, A; Bashashati, M; Gomez, Y; Hall, M; McCallum, RW; Sarosiek, I; Sarosiek, J; Shankar, N, 2016
)
3.32
"Lubiprostone is a bicyclic fatty acid metabolite analogue ofprostaglandin E1."( Lubiprostone: a novel treatment for chronic constipation.
Lacy, BE; Levy, LC, 2008
)
2.51
"Lubiprostone is a synthetic bicyclic fatty acid that is gut selective and stimulates type 2 chloride channels, resulting in increased chloride, sodium and water secretion into the lumen."( Lubiprostone for constipation and irritable bowel syndrome with constipation.
Rao, SS; Tuteja, AK, 2008
)
2.51
"Lubiprostone is a novel selective chloride channel-2 activator that increases fluid secretion in the intestinal apical cell membrane, increasing gut motility and frequency of stool passage, and alleviating abdominal discomfort/pain."( Lubiprostone--a novel treatment for irritable bowel syndrome with constipation.
Owen, RT, 2008
)
2.51
"Lubiprostone is a bicyclic fatty acid metabolite analogue of prostaglandin E1. "( Lubiprostone: chronic constipation and irritable bowel syndrome with constipation.
Chey, WD; Lacy, BE, 2009
)
3.24
"Lubiprostone is an oral bicyclic fatty acid that selectively activates type 2 chloride channels in the apical membrane of human gastrointestinal epithelial cells, thereby increasing chloride-rich fluid secretion. "( Lubiprostone: in constipation-predominant irritable bowel syndrome.
Carter, NJ; Scott, LJ, 2009
)
3.24
"Lubiprostone is a prostone analog with a novel mechanism of action involving type-2 chloride channel activation. "( Efficacy and safety of oral lubiprostone in constipated patients with or without irritable bowel syndrome: a randomized, placebo-controlled and dose-finding study.
Fukudo, S; Hongo, M; Kaneko, H; Ueno, R, 2011
)
2.11
"Lubiprostone is a laxative that works by activating the type 2 chloride channel in the gastrointestinal tract and thus has the potential to be especially effective for constipation associated with CF."( Lubiprostone for constipation in adults with cystic fibrosis: a pilot study.
Anderson, PJ; O'Brien, CE; Stowe, CD, 2011
)
2.53
"Lubiprostone is a chloride channel activator in clinical use for the treatment of chronic constipation, but the mechanisms of action of the drug are poorly understood. "( Lubiprostone targets prostanoid signaling and promotes ion transporter trafficking, mucus exocytosis, and contractility.
Ameen, NA; Collaco, AM; Jakab, RL, 2012
)
3.26
"Lubiprostone is a bicyclic fatty acid approved for the treatment of constipation [1]."( Lubiprostone activates CFTR, but not ClC-2, via the prostaglandin receptor (EP(4)).
MacDonald, KD; Moran, AR; Norimatsu, Y, 2012
)
2.54
"Lubiprostone is a synthetic bicyclic fatty acid derivative of prostaglandin E1 (PGE1) used for chronic constipation. "( Lubiprostone stimulates small intestinal mucin release.
De Lisle, RC, 2012
)
3.26
"Lubiprostone (Amitiza) is an oral bicyclic fatty acid that selectively activates type 2 chloride channels in the apical membrane of the gastrointestinal epithelium, resulting in increased fluid secretion. "( Lubiprostone.
McKeage, K; Plosker, GL; Siddiqui, MA, 2006
)
3.22
"Lubiprostone is a bicyclic fatty acid that acts locally on ClC-2 channels located in the apical membrane of intestinal epithelial cells."( Activation of type-2 chloride channels: a novel therapeutic target for the treatment of chronic constipation.
Crowell, MD; DiBaise, JK; Harris, LA; Olden, KW, 2007
)
1.06
"Lubiprostone is a chloride channel activator approved by the Food and Drug Administration for the treatment of chronic constipation. "( Lubiprostone: a chloride channel activator for treatment of chronic constipation.
Ambizas, EM; Ginzburg, R, 2007
)
3.23

Effects

Lubiprostone (Amitiza) has been approved by the US Food and Drug Administration (FDA) for the treatment of chronic-idiopathic constipation. The drug stimulates Cl(-) secretion, resulting in water and electrolyte secretion.

ExcerptReferenceRelevance
"Lubiprostone has demonstrated efficacy with respect to increasing weekly spontaneous bowel movements and improving stool consistency, straining and constipation severity, both in short- and long-term studies."( Lubiprostone for chronic idiopathic constipation and irritable bowel syndrome with constipation.
Chey, WD; Saad, R, 2008
)
2.51
"Lubiprostone has very low systemic bioavailability and cannot be quantitated in blood, but its active metabolite, M3, has been pharmacokinetically profiled."( Lubiprostone--a novel treatment for irritable bowel syndrome with constipation.
Owen, RT, 2008
)
2.51
"Lubiprostone has potential in treating OBD and deserves additional study. "( Lubiprostone for the treatment of opioid-induced bowel dysfunction.
Camilleri, M; Wong, BS, 2011
)
3.25
"Lubiprostone (Amitiza) has been approved by the US Food and Drug Administration (FDA) for the treatment of chronic-idiopathic constipation [6]."( Lubiprostone for the treatment of adults with constipation and irritable bowel syndrome.
Rao, SS; Schey, R, 2011
)
2.53
"Lubiprostone has no effect on visceral sensory thresholds. "( Lubiprostone does not influence visceral pain thresholds in patients with irritable bowel syndrome.
Gangarosa, L; Palsson, OS; Tucker, J; Turner, M; Whitehead, WE, 2011
)
3.25
"Lubiprostone has been used to treat constipation through its effects to stimulate Cl(-) secretion, resulting in water and electrolyte secretion."( Lubiprostone decreases mouse colonic inner mucus layer thickness and alters intestinal microbiota.
Chang, EB; Claud, EC; Musch, MW; Wang, Y, 2013
)
3.28
"Lubiprostone use has not been studied in the pediatric population."( Lubiprostone: a chloride channel activator for treatment of chronic constipation.
Ambizas, EM; Ginzburg, R, 2007
)
2.5
"Lubiprostone has fundamentally different cellular effects from prostaglandins that are not mediated by EP receptors."( Effects of lubiprostone on human uterine smooth muscle cells.
Chakrabarti, J; Cuppoletti, J; Malinowska, DH; Ueno, R, 2008
)
1.46

Actions

Lubiprostone did not cause clinically meaningful electrolyte imbalances or affect markers of renal function in either the short-term or long-term treatment of CIC or OIC.

ExcerptReferenceRelevance
"Lubiprostone did not cause clinically meaningful electrolyte imbalances or affect markers of renal function in either the short-term or long-term treatment of CIC or OIC."( Effects of Lubiprostone, an Intestinal Secretagogue, on Electrolyte Homeostasis in Chronic Idiopathic and Opioid-induced Constipation.
Habibi, S; Lichtlen, P; Rao, SSC, 2021
)
2.45
"Lubiprostone is shown to increase submucosal gland secretion in pigs, sheep, and humans and to increase short-circuit current (SCC) in the surface epithelium of pigs and sheep."( Lubiprostone stimulates secretion from tracheal submucosal glands of sheep, pigs, and humans.
Cuthbert, AW; Joo, NS; Wine, JJ, 2009
)
2.52

Treatment

The lubiprostone treatment ameliorated their chronic constipation and, unexpectedly, reduced the urinary protein excretion, urinary liver-type fatty acid binding protein and urine occult blood. Lubipro stone 24 μg BID treatment did not appear to affect opioid use or pain scores.

ExcerptReferenceRelevance
"The lubiprostone treatment ameliorated their chronic constipation and, unexpectedly, reduced the urinary protein excretion, urinary liver-type fatty acid binding protein and urine occult blood."( Effect of Lubiprostone on Urinary Protein Excretion: A Report of Two IgA Nephropathy Patients with Chronic Constipation.
Nakamura, T; Node, K; Sato, E; Takeshita, M; Tanaka, A, 2019
)
1.4
"Lubiprostone 24 μg BID treatment did not appear to affect opioid use or pain scores; changes from baseline were not significantly different with placebo vs."( Lubiprostone for Opioid-Induced Constipation Does Not Interfere with Opioid Analgesia in Patients with Chronic Noncancer Pain.
Brewer, RP; Losch-Beridon, T; Mareya, SM; Rauck, RL; Spierings, EL, 2017
)
2.62
"Lubiprostone-treated patients experienced greater mean numbers of SBMs at week 1 compared with placebo (5.89 versus 3.99, P = 0.0001), with significantly greater percentages having SBMs within 24 h of the first dose (61.3% versus 31.4%, P < 0.0001). "( Efficacy and safety of lubiprostone in patients with chronic constipation.
Barish, CF; Drossman, D; Johanson, JF; Ueno, R, 2010
)
2.11
"Oral treatment of lubiprostone effectively attenuated features of HFD-induced NAFLD including liver weight, plasma liver injury markers, and hepatic steatosis. "( Lubiprostone significantly represses fatty liver diseases via induction of mucin and HDL release in mice.
Han, YH; Kim, MY; Lee, SJ; Randolph, G, 2022
)
2.5
"Treatment with lubiprostone significantly restored expression of these genes to the control values."( Alleviation of cholestatic liver injury and intestinal permeability by lubiprostone treatment in bile duct ligated rats: role of intestinal FXR and tight junction proteins claudin-1, claudin-2, and occludin.
Ghasemi, M; Mehranfard, N; Safari, F; Sharifi, M; Talebi, A, 2023
)
1.48
"Pretreatment with lubiprostone significantly reduced the level of acid injury and significantly augmented the recovery of the injured tissue ("( Lubiprostone protects esophageal mucosa from acid injury in porcine esophagus.
Blikslager, AT; Garman, KS; Krüger, L; Pridgen, TA; Taylor, ER, 2020
)
2.32
"Treatment with lubiprostone showed significantly higher rates of gastrointestinal adverse events (P = 0.020), especially diarrhoea and nausea."( Clinical trial: phase 2 study of lubiprostone for irritable bowel syndrome with constipation.
Drossman, DA; Johanson, JF; Panas, R; Ueno, R; Wahle, A, 2008
)
0.97

Toxicity

Lubiprostone is an apical type 2 chloride channel activator approved for the treatment of chronic constipation (CC) nausea is the most common adverse symptom. In patients with irritable bowel syndrome with constipation, lubip rostone 8 mcg twice daily was found to be safe and well tolerated over 9-13 months of treatment.

ExcerptReferenceRelevance
" Spontaneous bowel movement (SBM) frequency, rescue medication use, symptom assessments and adverse events (AEs) were tracked."( Lubiprostone, a locally acting chloride channel activator, in adult patients with chronic constipation: a double-blind, placebo-controlled, dose-ranging study to evaluate efficacy and safety.
Johanson, JF; Ueno, R, 2007
)
1.78
" Gastrointestinal-related disorders were the most common adverse events in both treatment groups."( Efficacy and safety of lubiprostone in patients with chronic constipation.
Barish, CF; Drossman, D; Johanson, JF; Ueno, R, 2010
)
0.67
" Adverse events (AEs) were recorded."( Long-term safety and effectiveness of lubiprostone, a chloride channel (ClC-2) activator, in patients with chronic idiopathic constipation.
Johanson, JF; Lembo, AJ; Miner, PB; Parkman, HP; Rao, SS; Ueno, R, 2011
)
0.64
"The present review has several objectives, the first of which is to review the pharmacology and selectivity of serotonergic agents to contrast the older serotonergic agents (which were withdrawn because of cardiac or vascular adverse effects) with the newer generation serotonin receptor subtype 4 agonists."( New treatment options for chronic constipation: mechanisms, efficacy and safety.
Camilleri, M, 2011
)
0.37
" The primary objective was the assessment of long-term safety and tolerability, monitored via adverse events (AEs), laboratory parameters and vital signs."( Safety and patient outcomes with lubiprostone for up to 52 weeks in patients with irritable bowel syndrome with constipation.
Chey, WD; Drossman, DA; Johanson, JF; Panas, RM; Scott, C; Ueno, R, 2012
)
0.66
"In patients with irritable bowel syndrome with constipation, lubiprostone 8 mcg twice daily was found to be safe and well tolerated over 9-13 months of treatment."( Safety and patient outcomes with lubiprostone for up to 52 weeks in patients with irritable bowel syndrome with constipation.
Chey, WD; Drossman, DA; Johanson, JF; Panas, RM; Scott, C; Ueno, R, 2012
)
0.9
" It is generally considered to be safe and effective."( Safety evaluation of lubiprostone in the treatment of constipation and irritable bowel syndrome.
Chamberlain, SM; Rao, SS, 2012
)
0.69
" However, as with other stimulant or osmotic laxatives, adverse events (AEs) can make it difficult to continue treatment."( Risk Factors for Adverse Events in Patients with Chronic Constipation Following Lubiprostone Administration.
Eguchi, T; Hashimura, H; Ikeoka, S; Matsuda, T; Matsumoto, M; Miura, T; Momose, K; Morisawa, T; Okada, A; Okamoto, N; Otsuka, T; Takagi, M; Yoshizaki, T, 2021
)
0.85
" The most common lubiprostone-related adverse events in both groups were diarrhea (38."( The Efficacy and Safety of Lubiprostone for Constipation in Cancer Patients Compared with Non-cancer Patients: A Retrospective Cohort Study.
Esumi, S; Kajizono, M; Kitamura, Y; Sada, H; Sendo, T; Ushio, S, 2020
)
1.19
"To investigate the continuation rate with a reduced lubiprostone dose (12 mcg twice daily, BD) after the onset of adverse events (AEs) in patients with chronic constipation (CC)."( Open-label study to evaluate the treatment continuation rate after a dose reduction of lubiprostone due to onset of adverse events.
Asano, T; Kimura, T; Kiuchi, M; Nagazumi, A; Ohbayashi, H; Sato, Y, 2021
)
1.09
"We aimed to discuss and compare reported adverse reactions and drug add-ons associated with elobixibat and lubiprostone use in chronic constipation treatment, as the safety of these drugs has not been well examined in post-marketing clinical settings."( Safety of elobixibat and lubiprostone in Japanese patients with chronic constipation: a retrospective cohort study.
Kawakami, E; Kimura, M; Miyazaki, C; Nagamura, M; Ooba, N; Sato, T; Shimada, M; Takahashi, M; Takahashi, Y; Tokuyoshi, J; Ushida, M, 2021
)
1.14
" Safety endpoints included incidence of treatment-emergent adverse events (TEAEs) and changes from baseline in clinical laboratory parameters and vital signs."( Safety of Lubiprostone in Pediatric Patients With Functional Constipation: A Nonrandomized, Open-Label Trial.
Clifford, R; Hussain, SZ; Labrum, B; Mareya, S; Stripling, S, 2021
)
1.02
" Subgroup analyses assessed an impact of age, sex, and race categories on TEAEs and treatment-related adverse events."( Safety of Lubiprostone in Pediatric Patients With Functional Constipation: A Nonrandomized, Open-Label Trial.
Clifford, R; Hussain, SZ; Labrum, B; Mareya, S; Stripling, S, 2021
)
1.02
"Lubiprostone is an apical type 2 chloride channel activator approved for the treatment of chronic constipation (CC), and nausea is the most common adverse symptom."( Evaluation of efficacy and safety of lubiprostone in patients with chronic constipation.
Fukushima, S; Handa, O; Handa, Y; Matsumoto, H; Murao, T; Osawa, M; Shiotani, A; Umegaki, E; Yo, S, 2021
)
2.34
"8%), and the discontinuation due to adverse in 34 patients (21."( Evaluation of efficacy and safety of lubiprostone in patients with chronic constipation.
Fukushima, S; Handa, O; Handa, Y; Matsumoto, H; Murao, T; Osawa, M; Shiotani, A; Umegaki, E; Yo, S, 2021
)
0.89
" No drug-related serious adverse events (AEs) occurred."( Efficacy and safety of lubiprostone for the treatment of functional constipation in Chinese adult patients: A multicenter, randomized, double-blind, placebo-controlled trial.
Chen, MH; Dai, N; Fang, XC; He, SX; Hou, XH; Li, YQ; Liu, L; Liu, S; Liu, XW; Liu, YL; Shen, XZ; Sun, MJ; Tian, A; Tian, ZB; Wang, XY; Wen, ZL; Wu, YD; Xiao, YL; Xu, H; Zeng, WZ, 2021
)
0.93
" Patients who experienced adverse events (AEs) had their dose reduced to 12 mcg twice daily (for 4 weeks)."( Analysis of the impact on efficacy of lubiprostone dose reduction to manage adverse events in the treatment of chronic constipation in Japan.
Kanzo, T; Kimura, T; Kiuchi, M; Nagazumi, A; Ohbayashi, H; Sato, Y, 2022
)
0.99

Pharmacokinetics

Lubiprostone has beneficial effects in IBS-C. Its beneficial effects must be confirmed in the actual clinical scenario. European Medicines Agency's guideline.

ExcerptReferenceRelevance
"This review outlines the regulatory history, pharmacokinetic, pharmacodynamic and safety data in the treatment of IBS-C with a European perspective."( Lubiprostone: pharmacokinetic, pharmacodynamic, safety and regulatory aspects in the treatment of constipation-predominant irritable bowel syndrome.
De Ponti, F; Raschi, E, 2014
)
1.85
"Although interesting pharmacodynamic data suggest that lubiprostone may have additional mechanisms of action, its beneficial effects in IBS-C must be confirmed in the actual clinical scenario taking into account the new version of European Medicines Agency's guideline."( Lubiprostone: pharmacokinetic, pharmacodynamic, safety and regulatory aspects in the treatment of constipation-predominant irritable bowel syndrome.
De Ponti, F; Raschi, E, 2014
)
2.09
"A pharmacokinetic (PK) study and a bioequivalence (BE) study were conducted to investigate the PK characteristics and safety of lubiprostone in healthy Chinese subjects and to evaluate the BE between the test and the reference drugs."( Pharmacokinetics and Bioequivalence of the Lubiprostone Capsule in Healthy Chinese Subjects.
Li, X; Li, Y; Tu, S; Xu, B; Yu, H; Yuan, F; Zhang, P; Zhou, Y, 2023
)
1.38

Bioavailability

Lubiprostone has very low systemic bioavailability and cannot be quantitated in blood. Its active metabolite, M3, has been pharmacokinetically profiled.

ExcerptReferenceRelevance
" It is poorly absorbed after oral administration, and its metabolism occurs primarily in the stomach and jejunum."( Lubiprostone: chloride channel activator for chronic constipation.
Chagan, L; Rivkin, A, 2006
)
1.78
" Lubiprostone has very low systemic bioavailability and cannot be quantitated in blood, but its active metabolite, M3, has been pharmacokinetically profiled."( Lubiprostone--a novel treatment for irritable bowel syndrome with constipation.
Owen, RT, 2008
)
2.7
" Secretory agents have high specificity, low bioavailability and high efficacy."( Review article: new receptor targets for medical therapy in irritable bowel syndrome.
Camilleri, M, 2010
)
0.36
" Our objective was to evaluate the bioequivalence, pharmacokinetics (PK), and bioavailability of lubiprostone sprinkles vs lubiprostone capsules, compared with placebo."( Capsule and Sprinkle Formulations of Lubiprostone Are Not Biologically Similar in Patients with Functional Constipation.
Adams, A; Barish, C; Chen, A; Dennis, P; Krause, R; Lichtlen, P; Losch-Beridon, T; Mareya, S; Schneider, J, 2021
)
1.11
"A 1-week randomized, placebo-controlled, double-blinded, bioequivalence study (study 302) and a single-dose PK and bioavailability crossover study (study 304) were conducted."( Capsule and Sprinkle Formulations of Lubiprostone Are Not Biologically Similar in Patients with Functional Constipation.
Adams, A; Barish, C; Chen, A; Dennis, P; Krause, R; Lichtlen, P; Losch-Beridon, T; Mareya, S; Schneider, J, 2021
)
0.89

Dosage Studied

The risk of discontinuation of lubiprostone in cancer patients was high in patients with a body-mass index (BMI) <22, and low in patients using opioids and magnesium oxide dosage ≥1000 mg/d. In patients with chronic constipation, treatment with lubIProstone produces a BM in the majority of individuals within 24-48 h of initial dosing.

ExcerptRelevanceReference
"In patients with chronic constipation, treatment with lubiprostone produces a BM in the majority of individuals within 24-48 h of initial dosing and improves the frequency as well as other characteristics associated with BMs with short-term (i."( Multicenter, 4-week, double-blind, randomized, placebo-controlled trial of lubiprostone, a locally-acting type-2 chloride channel activator, in patients with chronic constipation.
Geenen, J; Johanson, JF; Morton, D; Ueno, R, 2008
)
0.82
" The nausea may be alleviated or minimized by administering the dose with food, and some patients may require a dosage reduction to 24 mug once daily."( Lubiprostone: a new drug for the treatment of chronic idiopathic constipation.
Baker, DE, 2007
)
1.78
" A clear dose-response relationship was detected in all murine strains."( Lubiprostone activates non-CFTR-dependent respiratory epithelial chloride secretion in cystic fibrosis mice.
Hawkins, CE; Henderson, MJ; MacDonald, KD; McKenzie, KR; Vij, N; Zeitlin, PL, 2008
)
1.79
" Logistic regression analysis showed that the risk of discontinuation of lubiprostone in cancer patients was high in patients with a body-mass index (BMI) <22, and low in patients using opioids and magnesium oxide dosage ≥1000 mg/d."( The Efficacy and Safety of Lubiprostone for Constipation in Cancer Patients Compared with Non-cancer Patients: A Retrospective Cohort Study.
Esumi, S; Kajizono, M; Kitamura, Y; Sada, H; Sendo, T; Ushio, S, 2020
)
1.09
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Protein Targets (7)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
TDP1 proteinHomo sapiens (human)Potency0.28230.000811.382244.6684AID686978; AID686979
AR proteinHomo sapiens (human)Potency30.10650.000221.22318,912.5098AID743036
glucocorticoid receptor [Homo sapiens]Homo sapiens (human)Potency10.68220.000214.376460.0339AID720692
estrogen nuclear receptor alphaHomo sapiens (human)Potency7.78710.000229.305416,493.5996AID743069; AID743075; AID743078; AID743080
peroxisome proliferator activated receptor gammaHomo sapiens (human)Potency21.31380.001019.414170.9645AID743094
cytochrome P450, family 19, subfamily A, polypeptide 1, isoform CRA_aHomo sapiens (human)Potency0.04220.001723.839378.1014AID743083
Cellular tumor antigen p53Homo sapiens (human)Potency0.66820.002319.595674.0614AID651631
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (124)

Processvia Protein(s)Taxonomy
negative regulation of cell population proliferationCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycleCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycle G2/M phase transitionCellular tumor antigen p53Homo sapiens (human)
DNA damage responseCellular tumor antigen p53Homo sapiens (human)
ER overload responseCellular tumor antigen p53Homo sapiens (human)
cellular response to glucose starvationCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
positive regulation of miRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
negative regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
mitophagyCellular tumor antigen p53Homo sapiens (human)
in utero embryonic developmentCellular tumor antigen p53Homo sapiens (human)
somitogenesisCellular tumor antigen p53Homo sapiens (human)
release of cytochrome c from mitochondriaCellular tumor antigen p53Homo sapiens (human)
hematopoietic progenitor cell differentiationCellular tumor antigen p53Homo sapiens (human)
T cell proliferation involved in immune responseCellular tumor antigen p53Homo sapiens (human)
B cell lineage commitmentCellular tumor antigen p53Homo sapiens (human)
T cell lineage commitmentCellular tumor antigen p53Homo sapiens (human)
response to ischemiaCellular tumor antigen p53Homo sapiens (human)
nucleotide-excision repairCellular tumor antigen p53Homo sapiens (human)
double-strand break repairCellular tumor antigen p53Homo sapiens (human)
regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
protein import into nucleusCellular tumor antigen p53Homo sapiens (human)
autophagyCellular tumor antigen p53Homo sapiens (human)
DNA damage responseCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediator resulting in cell cycle arrestCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediator resulting in transcription of p21 class mediatorCellular tumor antigen p53Homo sapiens (human)
transforming growth factor beta receptor signaling pathwayCellular tumor antigen p53Homo sapiens (human)
Ras protein signal transductionCellular tumor antigen p53Homo sapiens (human)
gastrulationCellular tumor antigen p53Homo sapiens (human)
neuroblast proliferationCellular tumor antigen p53Homo sapiens (human)
negative regulation of neuroblast proliferationCellular tumor antigen p53Homo sapiens (human)
protein localizationCellular tumor antigen p53Homo sapiens (human)
negative regulation of DNA replicationCellular tumor antigen p53Homo sapiens (human)
negative regulation of cell population proliferationCellular tumor antigen p53Homo sapiens (human)
determination of adult lifespanCellular tumor antigen p53Homo sapiens (human)
mRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
rRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
response to salt stressCellular tumor antigen p53Homo sapiens (human)
response to inorganic substanceCellular tumor antigen p53Homo sapiens (human)
response to X-rayCellular tumor antigen p53Homo sapiens (human)
response to gamma radiationCellular tumor antigen p53Homo sapiens (human)
positive regulation of gene expressionCellular tumor antigen p53Homo sapiens (human)
cardiac muscle cell apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of cardiac muscle cell apoptotic processCellular tumor antigen p53Homo sapiens (human)
glial cell proliferationCellular tumor antigen p53Homo sapiens (human)
viral processCellular tumor antigen p53Homo sapiens (human)
glucose catabolic process to lactate via pyruvateCellular tumor antigen p53Homo sapiens (human)
cerebellum developmentCellular tumor antigen p53Homo sapiens (human)
negative regulation of cell growthCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
negative regulation of transforming growth factor beta receptor signaling pathwayCellular tumor antigen p53Homo sapiens (human)
mitotic G1 DNA damage checkpoint signalingCellular tumor antigen p53Homo sapiens (human)
negative regulation of telomere maintenance via telomeraseCellular tumor antigen p53Homo sapiens (human)
T cell differentiation in thymusCellular tumor antigen p53Homo sapiens (human)
tumor necrosis factor-mediated signaling pathwayCellular tumor antigen p53Homo sapiens (human)
regulation of tissue remodelingCellular tumor antigen p53Homo sapiens (human)
cellular response to UVCellular tumor antigen p53Homo sapiens (human)
multicellular organism growthCellular tumor antigen p53Homo sapiens (human)
positive regulation of mitochondrial membrane permeabilityCellular tumor antigen p53Homo sapiens (human)
cellular response to glucose starvationCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
entrainment of circadian clock by photoperiodCellular tumor antigen p53Homo sapiens (human)
mitochondrial DNA repairCellular tumor antigen p53Homo sapiens (human)
regulation of DNA damage response, signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of neuron apoptotic processCellular tumor antigen p53Homo sapiens (human)
transcription initiation-coupled chromatin remodelingCellular tumor antigen p53Homo sapiens (human)
negative regulation of proteolysisCellular tumor antigen p53Homo sapiens (human)
negative regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
positive regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
positive regulation of RNA polymerase II transcription preinitiation complex assemblyCellular tumor antigen p53Homo sapiens (human)
positive regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
response to antibioticCellular tumor antigen p53Homo sapiens (human)
fibroblast proliferationCellular tumor antigen p53Homo sapiens (human)
negative regulation of fibroblast proliferationCellular tumor antigen p53Homo sapiens (human)
circadian behaviorCellular tumor antigen p53Homo sapiens (human)
bone marrow developmentCellular tumor antigen p53Homo sapiens (human)
embryonic organ developmentCellular tumor antigen p53Homo sapiens (human)
positive regulation of peptidyl-tyrosine phosphorylationCellular tumor antigen p53Homo sapiens (human)
protein stabilizationCellular tumor antigen p53Homo sapiens (human)
negative regulation of helicase activityCellular tumor antigen p53Homo sapiens (human)
protein tetramerizationCellular tumor antigen p53Homo sapiens (human)
chromosome organizationCellular tumor antigen p53Homo sapiens (human)
neuron apoptotic processCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycleCellular tumor antigen p53Homo sapiens (human)
hematopoietic stem cell differentiationCellular tumor antigen p53Homo sapiens (human)
negative regulation of glial cell proliferationCellular tumor antigen p53Homo sapiens (human)
type II interferon-mediated signaling pathwayCellular tumor antigen p53Homo sapiens (human)
cardiac septum morphogenesisCellular tumor antigen p53Homo sapiens (human)
positive regulation of programmed necrotic cell deathCellular tumor antigen p53Homo sapiens (human)
protein-containing complex assemblyCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to endoplasmic reticulum stressCellular tumor antigen p53Homo sapiens (human)
thymocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of thymocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
necroptotic processCellular tumor antigen p53Homo sapiens (human)
cellular response to hypoxiaCellular tumor antigen p53Homo sapiens (human)
cellular response to xenobiotic stimulusCellular tumor antigen p53Homo sapiens (human)
cellular response to ionizing radiationCellular tumor antigen p53Homo sapiens (human)
cellular response to gamma radiationCellular tumor antigen p53Homo sapiens (human)
cellular response to UV-CCellular tumor antigen p53Homo sapiens (human)
stem cell proliferationCellular tumor antigen p53Homo sapiens (human)
signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
cellular response to actinomycin DCellular tumor antigen p53Homo sapiens (human)
positive regulation of release of cytochrome c from mitochondriaCellular tumor antigen p53Homo sapiens (human)
cellular senescenceCellular tumor antigen p53Homo sapiens (human)
replicative senescenceCellular tumor antigen p53Homo sapiens (human)
oxidative stress-induced premature senescenceCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathwayCellular tumor antigen p53Homo sapiens (human)
oligodendrocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of execution phase of apoptosisCellular tumor antigen p53Homo sapiens (human)
negative regulation of mitophagyCellular tumor antigen p53Homo sapiens (human)
regulation of mitochondrial membrane permeability involved in apoptotic processCellular tumor antigen p53Homo sapiens (human)
regulation of intrinsic apoptotic signaling pathway by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of miRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
negative regulation of G1 to G0 transitionCellular tumor antigen p53Homo sapiens (human)
negative regulation of miRNA processingCellular tumor antigen p53Homo sapiens (human)
negative regulation of glucose catabolic process to lactate via pyruvateCellular tumor antigen p53Homo sapiens (human)
negative regulation of pentose-phosphate shuntCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to hypoxiaCellular tumor antigen p53Homo sapiens (human)
regulation of fibroblast apoptotic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of stem cell proliferationCellular tumor antigen p53Homo sapiens (human)
positive regulation of cellular senescenceCellular tumor antigen p53Homo sapiens (human)
positive regulation of intrinsic apoptotic signaling pathwayCellular tumor antigen p53Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (34)

Processvia Protein(s)Taxonomy
transcription cis-regulatory region bindingCellular tumor antigen p53Homo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
cis-regulatory region sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
core promoter sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
TFIID-class transcription factor complex bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription repressor activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription activator activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
protease bindingCellular tumor antigen p53Homo sapiens (human)
p53 bindingCellular tumor antigen p53Homo sapiens (human)
DNA bindingCellular tumor antigen p53Homo sapiens (human)
chromatin bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription factor activityCellular tumor antigen p53Homo sapiens (human)
mRNA 3'-UTR bindingCellular tumor antigen p53Homo sapiens (human)
copper ion bindingCellular tumor antigen p53Homo sapiens (human)
protein bindingCellular tumor antigen p53Homo sapiens (human)
zinc ion bindingCellular tumor antigen p53Homo sapiens (human)
enzyme bindingCellular tumor antigen p53Homo sapiens (human)
receptor tyrosine kinase bindingCellular tumor antigen p53Homo sapiens (human)
ubiquitin protein ligase bindingCellular tumor antigen p53Homo sapiens (human)
histone deacetylase regulator activityCellular tumor antigen p53Homo sapiens (human)
ATP-dependent DNA/DNA annealing activityCellular tumor antigen p53Homo sapiens (human)
identical protein bindingCellular tumor antigen p53Homo sapiens (human)
histone deacetylase bindingCellular tumor antigen p53Homo sapiens (human)
protein heterodimerization activityCellular tumor antigen p53Homo sapiens (human)
protein-folding chaperone bindingCellular tumor antigen p53Homo sapiens (human)
protein phosphatase 2A bindingCellular tumor antigen p53Homo sapiens (human)
RNA polymerase II-specific DNA-binding transcription factor bindingCellular tumor antigen p53Homo sapiens (human)
14-3-3 protein bindingCellular tumor antigen p53Homo sapiens (human)
MDM2/MDM4 family protein bindingCellular tumor antigen p53Homo sapiens (human)
disordered domain specific bindingCellular tumor antigen p53Homo sapiens (human)
general transcription initiation factor bindingCellular tumor antigen p53Homo sapiens (human)
molecular function activator activityCellular tumor antigen p53Homo sapiens (human)
promoter-specific chromatin bindingCellular tumor antigen p53Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (19)

Processvia Protein(s)Taxonomy
nuclear bodyCellular tumor antigen p53Homo sapiens (human)
nucleusCellular tumor antigen p53Homo sapiens (human)
nucleoplasmCellular tumor antigen p53Homo sapiens (human)
replication forkCellular tumor antigen p53Homo sapiens (human)
nucleolusCellular tumor antigen p53Homo sapiens (human)
cytoplasmCellular tumor antigen p53Homo sapiens (human)
mitochondrionCellular tumor antigen p53Homo sapiens (human)
mitochondrial matrixCellular tumor antigen p53Homo sapiens (human)
endoplasmic reticulumCellular tumor antigen p53Homo sapiens (human)
centrosomeCellular tumor antigen p53Homo sapiens (human)
cytosolCellular tumor antigen p53Homo sapiens (human)
nuclear matrixCellular tumor antigen p53Homo sapiens (human)
PML bodyCellular tumor antigen p53Homo sapiens (human)
transcription repressor complexCellular tumor antigen p53Homo sapiens (human)
site of double-strand breakCellular tumor antigen p53Homo sapiens (human)
germ cell nucleusCellular tumor antigen p53Homo sapiens (human)
chromatinCellular tumor antigen p53Homo sapiens (human)
transcription regulator complexCellular tumor antigen p53Homo sapiens (human)
protein-containing complexCellular tumor antigen p53Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (4)

Assay IDTitleYearJournalArticle
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.
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.
AID1794808Fluorescence-based screening to identify small molecule inhibitors of Plasmodium falciparum apicoplast DNA polymerase (Pf-apPOL).2014Journal of biomolecular screening, Jul, Volume: 19, Issue:6
A High-Throughput Assay to Identify Inhibitors of the Apicoplast DNA Polymerase from Plasmodium falciparum.
AID1794808Fluorescence-based screening to identify small molecule inhibitors of Plasmodium falciparum apicoplast DNA polymerase (Pf-apPOL).
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (206)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's59 (28.64)29.6817
2010's103 (50.00)24.3611
2020's44 (21.36)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 91.23

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 very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index91.23 (24.57)
Research Supply Index5.53 (2.92)
Research Growth Index4.70 (4.65)
Search Engine Demand Index163.10 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (91.23)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials38 (17.76%)5.53%
Reviews66 (30.84%)6.00%
Case Studies7 (3.27%)4.05%
Observational1 (0.47%)0.25%
Other102 (47.66%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (49)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Phase 3, 12-Week, Multicenter, Double-Blind, Randomized, Efficacy and Safety Study of Lubiprostone for the Treatment of Irritable Bowel Syndrome With Constipation [NCT00399542]Phase 3581 participants (Actual)Interventional2005-05-31Completed
A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Evaluate the Clinical Equivalence of Lubiprostone 24 Mcg Capsules (Anchen Pharmaceuticals, Inc.) With AMITIZA® (Lubiprostone) 24 Mcg Capsules (Sucampo Pharmaceuticals, Inc [NCT01372423]Phase 3808 participants (Actual)Interventional2011-05-31Completed
A Randomized, Placebo-controlled, Double-blinded, Multicenter Study of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo, in Adult Subjects With Chronic Idiopathic Constipation [NCT03097861]Phase 3552 participants (Actual)Interventional2017-03-13Completed
Short Term Safety and Efficacy of Lubiprostone in Adults With Cystic Fibrosis [NCT00706004]9 participants (Actual)Interventional2008-07-31Completed
Lubiprostone Plus Polyethylene Glycol-electrolyte Solutionvs. Placebo Plus Polyethylene Glycol-electrolyte Solution for Outpatient Colonoscopy Preparation: A Randomized, Double-blind, Placebo-controlled Trial [NCT00645801]Phase 4158 participants (Actual)Interventional2008-03-31Completed
A Multicenter, 6-month, Open-label Safety Study of Lubiprostone in Pediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation [NCT02766777]Phase 387 participants (Actual)Interventional2016-04-12Completed
Lubiprostone Effects on Visceral Pain Sensitivity [NCT01166789]Phase 162 participants (Actual)Interventional2008-02-29Completed
Randomized Double-Blind Placebo-Controlled Trial of Lubiprostone in the Treatment of Constipation Associated With Parkinson's Disease [NCT00908076]Phase 478 participants (Actual)Interventional2009-02-28Completed
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lubiprostone for the Treatment of Chronic Idiopathic Constipation [NCT02695719]Phase 3156 participants (Actual)Interventional2016-04-14Completed
Risk of Major Adverse Cardiovascular Events Among Users of Naldemedine Compared With Other Medications Used for Opioid Induced Constipation in Adult Patients With Chronic Non-Cancer Pain in a Healthcare Claims Database [NCT03720613]34,532 participants (Anticipated)Observational2019-01-04Recruiting
A Randomized, Double-blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Lubiprostone in Adult Subjects With Mixed or Unsubtyped Irritable Bowel Syndrome (IBS-M/IBS-U) [NCT02544152]Phase 271 participants (Actual)Interventional2015-02-28Terminated
Lubiprostone (Amitiza®) Compared to Standard Care in the Treatment of Postoperative Opioid-induced Constipation in Inpatient Rehabilitation Patients Following Orthopedic Procedures [NCT00662363]64 participants (Actual)Interventional2008-04-30Completed
Comparison of Colon Preparation With 2-Litre Polyethylene Glycol (PEG) Split-dose in Combination With Lubiprostone Versus 4-Litre Polyethylene Glycol (PEG) Split-dose: a Randomized Controlled Trial [NCT04138004]Phase 4140 participants (Actual)Interventional2019-12-01Completed
Efficacy of Lubiprostone Used With Polyethylene Glycol to Enhance Colonoscopy Preparation Quality in Diabetic Patients: A Randomized Single-Blind Controlled Trial [NCT00689026]60 participants (Actual)Interventional2008-05-31Terminated
The Effect of Lubiprostone, a Chloride Channel Activator, on Colonic Sensorimotor Functions in Healthy Subjects. A Phase IV, Placebo-Controlled, Parallel Group Study [NCT00953043]Phase 460 participants (Actual)Interventional2007-09-30Completed
Effects of Lubiprostone on Small Bowel and Colonic Bacteria: A Correlation Study With Segmental and Whole Gut Transit [NCT00844831]Phase 425 participants (Actual)Interventional2009-05-31Completed
Effect of Lubiprostone on Methanogenesis and Bowel Function in Chronic Constipation [NCT01190020]Phase 141 participants (Actual)Interventional2009-02-28Completed
The Intestinal Microecology in Chronic Constipation [NCT00934479]Phase 121 participants (Actual)Interventional2010-04-30Completed
Comparative Study of Lubiprostone and PEG Preparation Versus Conventional PEG Preparation to Enhance the Colonoscopy Preparation Quality in an Indian Tertiary Care Center. [NCT01324284]Phase 3442 participants (Actual)Interventional2011-03-31Completed
Phase 3, 12-Week, Multicenter, Double-Blind, Randomized, Efficacy and Safety Study of Lubiprostone for the Treatment of Irritable Bowel Syndrome With Constipation [NCT00380250]Phase 3590 participants (Actual)Interventional2005-05-31Completed
Efficacy and Tolerability of Lubiprostone in Patients With Nonalcoholic Fatty Liver Disease [NCT05768334]Phase 3116 participants (Actual)Interventional2020-11-01Completed
A Randomized, Double Blind, Placebo-controlled Trial to Examine the Effectiveness of Lubiprostone on Constipation Symptoms and Colon Transit Time in Diabetic Patients [NCT01170039]Phase 4121 participants (Actual)Interventional2010-09-30Completed
Single-center, Randomized, Double-blind, Placebo-controlled, Parallel-groups Study of Lubiprostone in Patients With Multiple Sclerosis-Associated Constipation [NCT01236534]Phase 421 participants (Actual)Interventional2010-11-30Completed
A Pilot Study to Assess the Effects of Lubiprostone on Gastrointestinal and Colonic Motility and pH in Patients With the Irritable Bowel Syndrome and Constipation (IBS-C) [NCT01162863]60 participants (Actual)Interventional2010-11-30Completed
Single Dose Lubiprostone Along With Split-dose PEG Solution Without Dietary Restrictions for Bowel Cleansing Prior to Colonoscopy, a Randomized, Double-blind, Placebo Controlled Trial [NCT00611442]191 participants (Actual)Interventional2007-10-31Completed
Comparison of Lubiprostone and Placebo for the Relief of Constipation From Constipating Medications [NCT01096290]Phase 423 participants (Actual)Interventional2010-04-30Terminated(stopped due to Number of needed participants could not be obtained)
A Randomized, Blinded Trial Comparing Miralax With Amitiza Pretreatment Versus Miralax With Dulcolax Pretreatment Versus Miralax Alone Without Pretreatment Versus Golytely for Bowel Cleansing Prior to Colonoscopy [NCT00953017]Phase 4425 participants (Actual)Interventional2009-07-31Completed
Lubiprostone for the Treatment of Functional Constipation in the Under 18 Years Patients: A Randomized, Controlled Trial. [NCT05144295]Phase 3274 participants (Actual)Interventional2022-01-01Completed
A Multi-center, Open-labeled Study of the Safety, Efficacy, and Pharmacokinetics of Lubiprostone in Pediatric Patients With Constipation [NCT00452335]Phase 4127 participants (Actual)Interventional2007-01-31Completed
A,Randomized , Double-blind,Double -Dummy Placebo-controlled,Parallel -Group, Multicenter Study to Evaluate the Clinical Equivalence of Lubiprostone 24 mcg Capsules ( Dr. Reddy's Laboratories Ltd.) With AMITIZA® (Lubiprostone ) 24 mcg Capsules ( Sucampo P [NCT01674530]Phase 3909 participants (Actual)Interventional2012-10-31Completed
A Randomized, Placebo-controlled, Double-blinded, Multicenter Study of the Pharmacodynamics, Pharmacokinetics, and Tolerability of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation [NCT01993875]Phase 3164 participants (Actual)Interventional2013-10-31Completed
Randomized, Placebo-controlled Trial of Lubiprostone as a Preparation for Capsule Endoscopy [NCT00746395]Phase 445 participants (Actual)Interventional2008-04-30Completed
The Effect of Adding Lubiprostone to Standard Large-Volume PEG-ELS on The Quality of Inpatient Colonoscopy Preparation. [NCT04361656]0 participants (Actual)Observational2020-05-01Withdrawn(stopped due to Endoscopy services were suspended in March 2019 due to COVID-19 pandemic. Study was not restarted.)
The Effect of Lubiprostone on Patterns of Contractions in the Small Bowel in Female Patients With Constipation Predominant Irritable Bowel Syndrome (C-IBS) [NCT01085643]4 participants (Actual)Interventional2010-03-31Completed
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lubiprostone for the Treatment of Chronic Idiopathic Constipation [NCT02729909]Phase 3211 participants (Actual)Interventional2016-05-11Completed
A Multicentre, Long-term Safety, Efficacy, and Pharmacokinetics Study of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation [NCT02138136]Phase 3419 participants (Actual)Interventional2014-02-26Completed
Comparative Pharmacokinetics and Food-Effect Bioavailability of a Sprinkle Formulation of Lubiprostone After Oral Administration in Healthy Volunteers [NCT03010631]Phase 349 participants (Actual)Interventional2016-11-16Completed
The Effect of Lubiprostone on Transit Times Within the Alimentary Tract, Measured by Novel Smartpill Methodology in Patients With Chronic Constipation [NCT01469819]Phase 2/Phase 337 participants (Actual)Interventional2012-06-30Completed
Lubiprostone as a Treatment for Constipation in Parkinson's Disease [NCT00669461]1 participants (Actual)Interventional2009-06-30Terminated(stopped due to Lack of recruitment)
A Multi-center, Open-labeled Study of the Long-term Safety and Efficacy of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction [NCT00620061]Phase 3439 participants (Actual)Interventional2007-12-31Completed
The Impact of Lubiprostone on Mucus Secretion in Asymptomatic Volunteers and Patients With Chronic Constipation [NCT01447849]Phase 2/Phase 340 participants (Actual)Interventional2011-08-31Completed
Effects of Lubiprostone on Gastric Sensory and Motor Function in Patients With Chronic Idiopathic Constipation [NCT01460225]Phase 419 participants (Actual)Interventional2007-09-30Completed
LAMBCHOP-Lubiprostone Activity Among the MicroBiota of the Colon in HIV in Opposing Permeability: Pilot Study of Lubiprostone as a Modulator of Gut Microbial Translocation in HIV With Incomplete CD4 T-cell Recovery on Antiretroviral Therapy [NCT01839734]Phase 220 participants (Actual)Interventional2013-06-30Completed
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lubiprostone for the Treatment of Chronic Idiopathic Constipation [NCT02651155]Phase 3204 participants (Actual)Interventional2016-03-02Completed
A Multi-center, Randomized, Double-Blinded Study of the Efficacy and Safety of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction (OBD) [NCT00595946]Phase 3439 participants (Actual)Interventional2007-08-31Completed
A Multi-center, Randomized, Double-Blinded Study of the Efficacy and Safety of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction (OBD) [NCT00597428]Phase 3437 participants (Actual)Interventional2007-08-31Completed
A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Lubiprostone in Subjects With Opioid-induced Bowel Dysfunction [NCT01298219]Phase 3439 participants (Actual)Interventional2010-12-31Completed
A Multicentre, Randomised, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation [NCT02042183]Phase 3606 participants (Actual)Interventional2013-12-13Completed
A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults [NCT02481947]Phase 3459 participants (Actual)Interventional2015-05-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00380250 (29) [back to overview]Month 2 Spontaneous Bowel Movement Frequency Rates Change From Baseline
NCT00380250 (29) [back to overview]Month 3 Stool Consistency Change From Baseline
NCT00380250 (29) [back to overview]Month 3 Spontaneous Bowel Movement Frequency Rates Change From Baseline
NCT00380250 (29) [back to overview]Month 3 Responder Rate
NCT00380250 (29) [back to overview]Month 3 Constipation Severity Change From Baseline
NCT00380250 (29) [back to overview]Month 3 Bowel Straining Change From Baseline
NCT00380250 (29) [back to overview]Month 1 Abdominal Bloating Change From Baseline
NCT00380250 (29) [back to overview]Month 1 Abdominal Pain Change From Baseline
NCT00380250 (29) [back to overview]Month 1 Bowel Movement Frequency Rates Change From Baseline
NCT00380250 (29) [back to overview]Month 1 Bowel Straining Change From Baseline
NCT00380250 (29) [back to overview]Month 1 Constipation Severity Change From Baseline
NCT00380250 (29) [back to overview]Month 1 Responder Rate
NCT00380250 (29) [back to overview]Month 1 Spontaneous Bowel Movement (SBM) Frequency Rates Change From Baseline
NCT00380250 (29) [back to overview]Month 1 Stool Consistency Change From Baseline
NCT00380250 (29) [back to overview]Month 1 Symptom Relief
NCT00380250 (29) [back to overview]Month 2 Abdominal Bloating Change From Baseline
NCT00380250 (29) [back to overview]Month 2 Abdominal Pain Change From Baseline
NCT00380250 (29) [back to overview]Month 2 Bowel Movement Frequency Rates Change From Baseline
NCT00380250 (29) [back to overview]Month 2 Bowel Straining Change From Baseline
NCT00380250 (29) [back to overview]Month 2 Constipation Severity Change From Baseline
NCT00380250 (29) [back to overview]Month 2 Responder Rate
NCT00380250 (29) [back to overview]Month 2 Stool Consistency Change From Baseline
NCT00380250 (29) [back to overview]Month 3 Symptom Relief
NCT00380250 (29) [back to overview]Month 2 Symptom Relief
NCT00380250 (29) [back to overview]Month 3 Abdominal Bloating Change From Baseline
NCT00380250 (29) [back to overview]Month 3 Abdominal Pain Change From Baseline
NCT00380250 (29) [back to overview]Quality of Life Change From Baseline
NCT00380250 (29) [back to overview]Month 3 Bowel Movement Frequency Rates Change From Baseline
NCT00380250 (29) [back to overview]Overall Responder Rate
NCT00399542 (29) [back to overview]Month 1 Abdominal Bloating Change From Baseline
NCT00399542 (29) [back to overview]Month 1 Abdominal Pain Change From Baseline
NCT00399542 (29) [back to overview]Month 1 Bowel Movement Rates Change From Baseline
NCT00399542 (29) [back to overview]Month 1 Bowel Straining Change From Baseline
NCT00399542 (29) [back to overview]Month 1 Constipation Severity Change From Baseline
NCT00399542 (29) [back to overview]Month 1 Responder Rate
NCT00399542 (29) [back to overview]Month 1 Spontaneous Bowel Movement Rates Change From Baseline
NCT00399542 (29) [back to overview]Month 1 Symptom Relief
NCT00399542 (29) [back to overview]Month 2 Abdominal Bloating Change From Baseline
NCT00399542 (29) [back to overview]Month 2 Abdominal Pain Change From Baseline
NCT00399542 (29) [back to overview]Month 2 Bowel Movement Rates Change From Baseline
NCT00399542 (29) [back to overview]Month 2 Bowel Straining Change From Baseline
NCT00399542 (29) [back to overview]Month 2 Constipation Severity Change From Baseline
NCT00399542 (29) [back to overview]Month 2 Responder Rate
NCT00399542 (29) [back to overview]Month 2 Spontaneous Bowel Movement Rates Change From Baseline
NCT00399542 (29) [back to overview]Month 2 Stool Consistency Change From Baseline
NCT00399542 (29) [back to overview]Month 2 Symptom Relief
NCT00399542 (29) [back to overview]Month 3 Abdominal Bloating Change From Baseline
NCT00399542 (29) [back to overview]Month 3 Abdominal Pain Change From Baseline
NCT00399542 (29) [back to overview]Month 3 Bowel Movement Rates Change From Baseline
NCT00399542 (29) [back to overview]Month 3 Bowel Straining Change From Baseline
NCT00399542 (29) [back to overview]Month 3 Quality of Life Change From Baseline
NCT00399542 (29) [back to overview]Month 3 Responder Rate
NCT00399542 (29) [back to overview]Month 3 Spontaneous Bowel Movement Rates Change From Baseline
NCT00399542 (29) [back to overview]Month 3 Stool Consistency Change From Baseline
NCT00399542 (29) [back to overview]Month 3 Symptom Relief
NCT00399542 (29) [back to overview]Overall Responder Status
NCT00399542 (29) [back to overview]Month 1 Stool Consistency Change From Baseline
NCT00399542 (29) [back to overview]Month 3 Constipation Severity Change From Baseline
NCT00452335 (10) [back to overview]Frequency of Spontaneous Bowel Movements
NCT00452335 (10) [back to overview]Pain Associated With SBMs
NCT00452335 (10) [back to overview]Stool Consistency of SBMs
NCT00452335 (10) [back to overview]Straining Associated With SBMs
NCT00452335 (10) [back to overview]Treatment Effectiveness
NCT00452335 (10) [back to overview]Abdominal Bloating
NCT00452335 (10) [back to overview]Frequency of Spontaneous Bowel Movements
NCT00452335 (10) [back to overview]Abdominal Discomfort
NCT00452335 (10) [back to overview]Constipation Severity
NCT00452335 (10) [back to overview]Frequency of Fecal Incontinence
NCT00595946 (6) [back to overview]Number of Participants With the First Post-dose Spontaneous Bowel Movement Within 48 Hours Post-dose
NCT00595946 (6) [back to overview]Mean Weekly Spontaneous Bowel Movements at Week 8
NCT00595946 (6) [back to overview]Number of Participants Classified as Responders
NCT00595946 (6) [back to overview]Participant Reported Outcome of Treatment Effectiveness
NCT00595946 (6) [back to overview]Mean Number of Spontaneous Bowel Movements (SBM) Per Week Within 12 Weeks
NCT00595946 (6) [back to overview]Mean Change From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity
NCT00597428 (6) [back to overview]Change From Baseline in Mean Weekly SBM Frequency
NCT00597428 (6) [back to overview]Treatment Effectiveness
NCT00597428 (6) [back to overview]Responder Rate
NCT00597428 (6) [back to overview]Change From Baseline in Mean Weekly Spontaneous Bowel Movement (SBM) Frequency in Subjects Without Dose Reduction Prior to Week 8
NCT00597428 (6) [back to overview]Mean Changes From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity
NCT00597428 (6) [back to overview]First Post-dose SBM
NCT00611442 (4) [back to overview]The Overall Cleanliness of the Prep as Measured by the Ottawa Scale
NCT00611442 (4) [back to overview]The Number of Polyps Detected on Examination
NCT00611442 (4) [back to overview]Patient Satisfaction With the Prep Measured by 5 Point Likert Scale
NCT00611442 (4) [back to overview]Procedure Time
NCT00620061 (12) [back to overview]Stool Consistency of Spontaneous Bowel Movements by Month
NCT00620061 (12) [back to overview]Number of Participants Classified as Monthly Responders
NCT00620061 (12) [back to overview]Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month
NCT00620061 (12) [back to overview]Mean Weekly Bowel Movements (BMs) Per Month
NCT00620061 (12) [back to overview]Constipation Severity by Month
NCT00620061 (12) [back to overview]Bowel Habit Regularity by Month
NCT00620061 (12) [back to overview]Abdominal Discomfort by Month
NCT00620061 (12) [back to overview]Straining Associated With Spontaneous Bowel Movements by Month
NCT00620061 (12) [back to overview]Abdominal Bloating by Month
NCT00620061 (12) [back to overview]Mean Weekly Complete SBMs by Month
NCT00620061 (12) [back to overview]Mean Weekly Complete BMs by Month
NCT00620061 (12) [back to overview]Treatment Effectiveness by Month
NCT00645801 (3) [back to overview]Endoscopist Evaluation of Colon Cleanliness in the Lubiprostone Group vs the Placebo Group
NCT00645801 (3) [back to overview]Tolerability of the Colon Cleansing Group in the Lubiprostone Group vs the Placebo Group
NCT00645801 (3) [back to overview]Change in Volume of PEG From Beginning of Bowel Prep to That at Completion of the Colonoscopy Preparation in the Two Groups
NCT00662363 (2) [back to overview]Change in Patient Assessment of Constipation - Quality of Life
NCT00662363 (2) [back to overview]Change in Patient Assessment of Constipation (PAC) - Symptoms (Sym)
NCT00689026 (1) [back to overview]The Percentage of Patients That Received a Quality of Colonoscopy Preparation Rating of <=2 on a 5 Point Likert Scale.
NCT00706004 (22) [back to overview]Serum Phosphate
NCT00706004 (22) [back to overview]Serum Prealbumin
NCT00706004 (22) [back to overview]ALT
NCT00706004 (22) [back to overview]AST
NCT00706004 (22) [back to overview]Body Mass Index
NCT00706004 (22) [back to overview]Bristol Stool Scale Score
NCT00706004 (22) [back to overview]Number of Spontaneous Bowel Movements Per Week
NCT00706004 (22) [back to overview]Self Reported Adverse Effects at Each Study Visit
NCT00706004 (22) [back to overview]Serum Albumin
NCT00706004 (22) [back to overview]Serum Bicarb
NCT00706004 (22) [back to overview]Serum BUN
NCT00706004 (22) [back to overview]Serum Calcium
NCT00706004 (22) [back to overview]Serum Chloride
NCT00706004 (22) [back to overview]Serum Creatinine
NCT00706004 (22) [back to overview]Serum Glucose
NCT00706004 (22) [back to overview]Serum Magnesium
NCT00706004 (22) [back to overview]Serum Potassium
NCT00706004 (22) [back to overview]Serum Vitamin E
NCT00706004 (22) [back to overview]Serum Vitamin D
NCT00706004 (22) [back to overview]Serum Vitamin A
NCT00706004 (22) [back to overview]Patient Assessment of Constipation Symptoms
NCT00706004 (22) [back to overview]Serum Sodium
NCT00746395 (2) [back to overview]Small Bowel Transit
NCT00746395 (2) [back to overview]Complete Small Bowel Transit
NCT00844831 (2) [back to overview]Small Intestinal Bacterial Overgrowth (SIBO)
NCT00844831 (2) [back to overview]Presence of Small Intestinal Bacterial Overgrowth
NCT00908076 (1) [back to overview]Change From Baseline to End of Study
NCT00953017 (4) [back to overview]Patient Satisfaction With the Prep Measured by 5 Point Likert Scale
NCT00953017 (4) [back to overview]Polyps Detected
NCT00953017 (4) [back to overview]Procedure Time
NCT00953017 (4) [back to overview]The Cleanliness of the Prep as Measured by the Ottawa Scale
NCT00953043 (8) [back to overview]Colonic Compliance
NCT00953043 (8) [back to overview]Median Pressure When Pain Sensation Was First Reported by 50% of Participants
NCT00953043 (8) [back to overview]Postprandial Colonic Tone
NCT00953043 (8) [back to overview]Median Pressure When First Sensation Was Reported by 50% of Participants
NCT00953043 (8) [back to overview]Median Pressure When Gas Sensation Was First Reported by 50% of Participants
NCT00953043 (8) [back to overview]Gas Sensation Ratings in Response to Colonic Distensions at 32 mm Hg Above Baseline Operating Pressure
NCT00953043 (8) [back to overview]Fasting Colonic Tone
NCT00953043 (8) [back to overview]Pain Sensation Ratings in Response to Colonic Distension at 32 mm HG Above Baseline Operating Pressure
NCT01096290 (1) [back to overview]Relief of Constipation Defined by Modified ROME Criteria
NCT01162863 (3) [back to overview]Change in Motility Pattern of the Small Bowel and Colon From Baseline as Defined by the Motility Index
NCT01162863 (3) [back to overview]Change in Small Bowel pH and Colon pH From Baseline
NCT01162863 (3) [back to overview]Change in Gastric Emptying Time, Small Bowel Transit Time, Colon Transit Time and Whole Gut Transit Time From Baseline
NCT01170039 (4) [back to overview]Efficacy, Measured by the Average Number of Spontaneous Bowel Movements (SBMs) Per Week
NCT01170039 (4) [back to overview]Change in Scores on the Patient Assessment of Constipation Quality of Life (PAC-QOL) Questionnaire
NCT01170039 (4) [back to overview]Number of Subjects With Daily Abdominal Discomfort
NCT01170039 (4) [back to overview]Efficacy, Measured by the Duration of Colonic Transit Time as Measured by the SmartPill pH Capsule
NCT01190020 (4) [back to overview]Change in Methane Production
NCT01190020 (4) [back to overview]Peak Methane Value
NCT01190020 (4) [back to overview]Percentage Change in the Colonic Transit Time
NCT01190020 (4) [back to overview]Stool Frequency (Complete Spontaneous Bowel Movements)
NCT01236534 (2) [back to overview]Number of Spontaneous Bowel Movements in Patients With Multiple Sclerosis (MS)-Associated Constipation Per Day.
NCT01236534 (2) [back to overview]Number of Participants With Diarrheic Events.
NCT01298219 (5) [back to overview]Number of Participants Who Experienced First SBM Within 48 Hours After Dose Initiation
NCT01298219 (5) [back to overview]Number of SBMs Per Week at Week 8
NCT01298219 (5) [back to overview]Number of SBMs Per Week at Week 12
NCT01298219 (5) [back to overview]Number of Participants Classified as Treatment Responders Within 12 Weeks
NCT01298219 (5) [back to overview]Number of SBMs Per Week Overall
NCT01447849 (2) [back to overview]Change of Mucus and Mucin Secretion in Patients With Chronic Constipation and in Controls.
NCT01447849 (2) [back to overview]Change in Viscoelasticity of Gastric Secretion in Controls and Patients With Chronic Constipation.
NCT01460225 (1) [back to overview]Gastric Emptying
NCT01469819 (5) [back to overview]Changes in Number of Bowel Movements in Chronically Constipated Patients After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day (BID).
NCT01469819 (5) [back to overview]Changes in Number of Bowel Movements Per Week Changes GE, SB, LB and WG Transit Times Measured by SmartPill in Chronically Constipated Patients Treated for 2 Weeks With Lubiprostone 24mcg Twice a Day.
NCT01469819 (5) [back to overview]Changes in Time of GE, SB, LB and WG Transits Measured by SmartPill After 2 Weeks of Lubiprostone 24mcg BID in Chronically Constipated Patients.
NCT01469819 (5) [back to overview]Elimination of Small Intestine Bacterial Overgrowth (SIBO) in Chronically Constipated Patients Treated With Lubiprostone 24mcg Twice a Day for 2 Weeks.
NCT01469819 (5) [back to overview]Time Reduction (Hours and Minutes) of Gastric Emptying (GE), Small Bowel (SB), Large Bowel (LB) and Whole Gut (WG) Transits Measured by SmartPill in Chronically Constipated Patients Before and After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day.
NCT01839734 (8) [back to overview]Changes in Gut Microbial Translocation (Zonulin)
NCT01839734 (8) [back to overview]Changes in Systemic Inflammation (IL-6)
NCT01839734 (8) [back to overview]Changes in Systemic Inflammation (hsCRP)
NCT01839734 (8) [back to overview]Changes in Gut Microbial Translocation (sCD163)
NCT01839734 (8) [back to overview]Changes in Gut Microbial Translocation (sCD14)
NCT01839734 (8) [back to overview]Changes in Gut Microbial Translocation (iFABP)
NCT01839734 (8) [back to overview]Changes in Peripheral CD4+
NCT01839734 (8) [back to overview]Number of Participants With Adverse Events During Study Period
NCT01993875 (6) [back to overview]Overall Straining at Week 1
NCT01993875 (6) [back to overview]Consistency of SBMs at Week 1
NCT01993875 (6) [back to overview]Mean Change From Baseline in Stool Consistency at Week 1
NCT01993875 (6) [back to overview]Mean Change From Baseline in Straining at Week 1
NCT01993875 (6) [back to overview]Number of Spontaneous Bowel Movements (SBMs) Within 1 Week
NCT01993875 (6) [back to overview]Overall Stool Consistency at Week 1
NCT02042183 (2) [back to overview]Number of Participants Classified as Overall Responders at Week 12
NCT02042183 (2) [back to overview]Mean Number of SBMs Observed Each Week for 12 Weeks
NCT02138136 (4) [back to overview]Median Monthly Score on a Stool Consistency Scale Associated With Observed SBMs
NCT02138136 (4) [back to overview]Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month
NCT02138136 (4) [back to overview]Median Monthly Score on a 5-point Straining Scale Associated With Observed SBMs
NCT02138136 (4) [back to overview]Median Monthly Score on a 4-point Pain Scale for Observed Abdominal Pain
NCT02481947 (1) [back to overview]Complete Spontaneous Bowel Movement (CSBM) Response
NCT02544152 (9) [back to overview]Number of Participants Classified as a Monthly Responder for IBS Symptoms
NCT02544152 (9) [back to overview]Number of Participants Classified as a Monthly Responder for Abdominal Pain
NCT02544152 (9) [back to overview]Number of Participants Classified as a Weekly Responder for Irritable Bowel Syndrome (IBS) Symptoms
NCT02544152 (9) [back to overview]Number of Participants Classified as a Weekly Responder for Stool Consistency
NCT02544152 (9) [back to overview]Number of Participants Classified as a Monthly Responder for Stool Consistency
NCT02544152 (9) [back to overview]Number of Participants Classified as an Overall Responder for Abdominal Pain
NCT02544152 (9) [back to overview]Number of Participants Classified as an Overall Responder for Stool Consistency
NCT02544152 (9) [back to overview]Number of Participants Classified as an Overall Responder for IBS Symptoms
NCT02544152 (9) [back to overview]Number of Participants Classified as a Weekly Responder for Abdominal Pain
NCT02651155 (6) [back to overview]Percentage of Participants Who Had a SBM Within 24 Hours After the First Dose of Study Medication
NCT02651155 (6) [back to overview]Spontaneous Bowel Movement (SBM) Frequency at Week 1
NCT02651155 (6) [back to overview]Mean Degree of Straining Score
NCT02651155 (6) [back to overview]Mean Degree Stool Consistency Score
NCT02651155 (6) [back to overview]SBM Frequency at Weeks 2, 3 and 4
NCT02651155 (6) [back to overview]Weekly Abdominal Symptoms Score
NCT02695719 (7) [back to overview]Weekly Responder Rate
NCT02695719 (7) [back to overview]Weekly Abdominal Symptoms Score
NCT02695719 (7) [back to overview]SBM Frequency at Weeks 2, 3 and 4
NCT02695719 (7) [back to overview]Mean Degree Stool Consistency Score
NCT02695719 (7) [back to overview]Mean Degree of Straining Score
NCT02695719 (7) [back to overview]Spontaneous Bowel Movement (SBM) Frequency at Week 1
NCT02695719 (7) [back to overview]Percentage of Participants Who Had a SBM Within 24 Hours After the First Dose of Study Medication
NCT02729909 (6) [back to overview]Weekly Abdominal Symptoms Score
NCT02729909 (6) [back to overview]SBM Frequency at Weeks 2, 3 and 4
NCT02729909 (6) [back to overview]Mean Degree of Straining Score
NCT02729909 (6) [back to overview]Mean Degree of Stool Consistency
NCT02729909 (6) [back to overview]Spontaneous Bowel Movement (SBM) Frequency at Week 1 of Administration
NCT02729909 (6) [back to overview]Percentage of Participants Who Have a SBM Within 24 Hours After First Dose of Study Medication
NCT02766777 (1) [back to overview]Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
NCT03010631 (5) [back to overview]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT03010631 (5) [back to overview]Cohort 2: Total Exposure (AUC0-t) of M3 With Administration of Sprinkle Lubiprostone Under Fed Versus (vs) Fasted Condition
NCT03010631 (5) [back to overview]Cohort 1: Maximum Observed Concentration (Cmax) of M3 Metabolite
NCT03010631 (5) [back to overview]Cohort 1: Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measurable Concentration (AUC0-t) of M3 Metabolite
NCT03010631 (5) [back to overview]Cohort 2: Maximum Observed Concentration (Cmax) of M3 Metabolite in Fed vs Fasted Conditions
NCT03097861 (4) [back to overview]Mean SBM Consistency Score Within 1 Week
NCT03097861 (4) [back to overview]Observed Spontaneous Bowel Movement (SBM) Count Within 1 Week
NCT03097861 (4) [back to overview]Mean SBM Straining Score Within 1 Week
NCT03097861 (4) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Month 2 Spontaneous Bowel Movement Frequency Rates Change From Baseline

Any bowel movement not associated with rescue medication use (NCT00380250)
Timeframe: Change from baseline for month 2

InterventionSBM/week (Mean)
Lubiprostone Study Period I1.59
Placebo Study Period I1.41

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Month 3 Stool Consistency Change From Baseline

0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls) (NCT00380250)
Timeframe: Change from baseline for month 3

InterventionScale score (Mean)
Lubiprostone Study Period I-0.52
Placebo Study Period I-0.41

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Month 3 Spontaneous Bowel Movement Frequency Rates Change From Baseline

Any bowel movement not associated with rescue medication use (NCT00380250)
Timeframe: Change from baseline for month 3

InterventionSBM/week (Mean)
Lubiprostone Study Period I1.51
Placebo Study Period I1.39

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Month 3 Responder Rate

"Symptoms >= Moderately relieved for 4 weeks/month or Significantly relieved for >=2 weeks/month AND:~Rescue medication use does not increase during the month as compared to baseline;~No discontinuation during the month due to lack of efficacy;AND~No ratings during the month of Moderately worse or Significantly worse." (NCT00380250)
Timeframe: month 3 (28 days)

Interventionpercent of participants (Number)
Lubiprostone Study Period I15.9
Placebo Study Period I10.4

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Month 3 Constipation Severity Change From Baseline

0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe (NCT00380250)
Timeframe: Change from baseline for month 3

InterventionScale score (Mean)
Lubiprostone Study Period I-0.51
Placebo Study Period I-0.41

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Month 3 Bowel Straining Change From Baseline

0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe (NCT00380250)
Timeframe: Change from baseline for month 3

InterventionScale score (Mean)
Lubiprostone Study Period I-0.56
Placebo Study Period I-0.45

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Month 1 Abdominal Bloating Change From Baseline

0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe (NCT00380250)
Timeframe: Change from baseline for month 1

InterventionScale score (Mean)
Lubiprostone Study Period I-0.30
Placebo Study Period I-0.24

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Month 1 Abdominal Pain Change From Baseline

0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe (NCT00380250)
Timeframe: Change from baseline for month 1

InterventionScale Score (Mean)
Lubiprostone Study Period I-0.29
Placebo Study Period I-0.27

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Month 1 Bowel Movement Frequency Rates Change From Baseline

(NCT00380250)
Timeframe: Change from baseline for month 1

InterventionBM/week (Mean)
Lubiprostone Study Period I1.22
Placebo Study Period I0.88

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Month 1 Bowel Straining Change From Baseline

0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe (NCT00380250)
Timeframe: Change from baseline for month 1

InterventionScale score (Mean)
Lubiprostone Study Period I-0.53
Placebo Study Period I-0.36

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Month 1 Constipation Severity Change From Baseline

0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe (NCT00380250)
Timeframe: Change from baseline at 28 days

InterventionScale score (Mean)
Lubiprostone Study Period I-0.41
Placebo Study Period I-0.29

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Month 1 Responder Rate

"Symptoms >= Moderately relieved for 4 weeks/month or Significantly relieved for >=2 weeks/month AND:~Rescue medication use does not increase during the month as compared to baseline;~No discontinuation during the month due to lack of efficacy;AND~No ratings during the month of Moderately worse or Significantly worse." (NCT00380250)
Timeframe: month 1 (28 days)

Interventionpercent of participants (Number)
Lubiprostone Study Period I10.0
Placebo Study Period I6.2

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Month 1 Spontaneous Bowel Movement (SBM) Frequency Rates Change From Baseline

SBMs are any bowel movement not associated with rescue medication use. (NCT00380250)
Timeframe: Change from baseline for month 1

InterventionSBM/week (Mean)
Lubiprostone Study Period I1.54
Placebo Study Period I1.21

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Month 1 Stool Consistency Change From Baseline

0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls) (NCT00380250)
Timeframe: Change from baseline for month 1

InterventionScale score (Mean)
Lubiprostone Study Period I-0.51
Placebo Study Period I-0.33

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Month 1 Symptom Relief

Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3 (NCT00380250)
Timeframe: Change from baseline for month 1

InterventionScale score (Mean)
Lubiprostone Study Period I0.66
Placebo Study Period I0.57

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Month 2 Abdominal Bloating Change From Baseline

0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe (NCT00380250)
Timeframe: Change from baseline for month 2

InterventionScale score (Mean)
Lubiprostone Study Period I-0.42
Placebo Study Period I-0.35

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Month 2 Abdominal Pain Change From Baseline

0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe (NCT00380250)
Timeframe: Change from baseline for month 2

InterventionScale Score (Mean)
Lubiprostone Study Period I-0.43
Placebo Study Period I-0.37

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Month 2 Bowel Movement Frequency Rates Change From Baseline

(NCT00380250)
Timeframe: Change from baseline for month 2

InterventionBM/week (Mean)
Lubiprostone Study Period I1.23
Placebo Study Period I1.10

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Month 2 Bowel Straining Change From Baseline

0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe (NCT00380250)
Timeframe: Change from baseline for month 2

InterventionScale score (Mean)
Lubiprostone Study Period I-0.58
Placebo Study Period I-0.43

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Month 2 Constipation Severity Change From Baseline

0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe (NCT00380250)
Timeframe: Change from baseline for month 2

InterventionScale score (Mean)
Lubiprostone Study Period I-0.50
Placebo Study Period I-0.40

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Month 2 Responder Rate

"Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:~Rescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month." (NCT00380250)
Timeframe: month 2 (28 days)

Interventionpercent of participants (Number)
Lubiprostone Study Period I15.9
Placebo Study Period I9.3

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Month 2 Stool Consistency Change From Baseline

0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls) (NCT00380250)
Timeframe: Change from baseline for month 2

InterventionScale score (Mean)
Lubiprostone Study Period I-0.53
Placebo Study Period I-0.38

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Month 3 Symptom Relief

Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3 (NCT00380250)
Timeframe: Change from baseline for month 3

InterventionScale score (Mean)
Lubiprostone Study Period I0.74
Placebo Study Period I0.57

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Month 2 Symptom Relief

Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3 (NCT00380250)
Timeframe: Change from baseline for month 2

InterventionScale score (Mean)
Lubiprostone Study Period I0.76
Placebo Study Period I0.59

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Month 3 Abdominal Bloating Change From Baseline

0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe (NCT00380250)
Timeframe: Change from baseline for month 3

InterventionScale score (Mean)
Lubiprostone Study Period I-0.43
Placebo Study Period I-0.37

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Month 3 Abdominal Pain Change From Baseline

0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe (NCT00380250)
Timeframe: Change from baseline for month 3

InterventionScale Score (Mean)
Lubiprostone Study Period I-0.42
Placebo Study Period I-0.36

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Quality of Life Change From Baseline

Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire included 34 questions with 5 possible responses yielding the following sub-categories: dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationship Results range from 34 (low) to 100 (high); meaningful clinical improvement=14 point increase (NCT00380250)
Timeframe: Change from baseline at 12 weeks

InterventionScale score (Mean)
Lubiprostone Study Period I16.7
Placebo Study Period I16.8

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Month 3 Bowel Movement Frequency Rates Change From Baseline

(NCT00380250)
Timeframe: Change from baseline for month 3

InterventionBM/week (Mean)
Lubiprostone Study Period I1.15
Placebo Study Period I1.04

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Overall Responder Rate

"Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:~Rescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month.~Overall responder: responder for at least 2/3 months" (NCT00380250)
Timeframe: 12 weeks

Interventionpercentage of participants (Number)
Lubiprostone Study Period I13.8
Placebo Study Period I7.8

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Month 1 Abdominal Bloating Change From Baseline

0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe (NCT00399542)
Timeframe: 28 days

Interventionunits on a scale (Mean)
Lubiprostone-0.31
Placebo-0.28

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Month 1 Abdominal Pain Change From Baseline

0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe (NCT00399542)
Timeframe: 28 days

Interventionunits on a scale (Mean)
Lubiprostone-0.32
Placebo-0.29

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Month 1 Bowel Movement Rates Change From Baseline

(NCT00399542)
Timeframe: 28 days

Interventionbowel movements (BMs)/week (Mean)
Lubiprostone1.30
Placebo0.87

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Month 1 Bowel Straining Change From Baseline

0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe (NCT00399542)
Timeframe: 28 days

Interventionunits on a scale (Mean)
Lubiprostone-0.54
Placebo-0.42

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Month 1 Constipation Severity Change From Baseline

0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe (NCT00399542)
Timeframe: 28 days

Interventionunits on a scale (Mean)
Lubiprostone-0.41
Placebo-0.33

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Month 1 Responder Rate

"Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:~Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month." (NCT00399542)
Timeframe: 28 days

Interventionpercentage of participants (Number)
Lubiprostone9.8
Placebo6.8

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Month 1 Spontaneous Bowel Movement Rates Change From Baseline

Any bowel movement not associated with rescue medication use (NCT00399542)
Timeframe: 28 days

Interventionspontaneous bowel movements (SBMs)/week (Mean)
Lubiprostone1.55
Placebo1.29

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Month 1 Symptom Relief

"3 = Significantly worse, -2 = Moderately worse,~1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved" (NCT00399542)
Timeframe: 28 days

Interventionunits on a scale (Mean)
Lubiprostone0.69
Placebo0.60

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Month 2 Abdominal Bloating Change From Baseline

0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe (NCT00399542)
Timeframe: 28 days

Interventionunits on a scale (Mean)
Lubiprostone-0.43
Placebo-0.33

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Month 2 Abdominal Pain Change From Baseline

0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe (NCT00399542)
Timeframe: 28 days

Interventionunits on a scale (Mean)
Lubiprostone-0.44
Placebo-0.33

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Month 2 Bowel Movement Rates Change From Baseline

(NCT00399542)
Timeframe: 28 days

InterventionBMs/week (Mean)
Lubiprostone1.29
Placebo0.95

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Month 2 Bowel Straining Change From Baseline

0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe (NCT00399542)
Timeframe: 28 days

Interventionunits on a scale (Mean)
Lubiprostone-0.62
Placebo-0.50

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Month 2 Constipation Severity Change From Baseline

0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe (NCT00399542)
Timeframe: 28 days

Interventionunits on a scale (Mean)
Lubiprostone-0.51
Placebo-0.42

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Month 2 Responder Rate

"Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:~Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month." (NCT00399542)
Timeframe: 28 days

Interventionpercentage of participants (Number)
Lubiprostone16.1
Placebo9.9

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Month 2 Spontaneous Bowel Movement Rates Change From Baseline

Any bowel movement not associated with rescue medication use (NCT00399542)
Timeframe: 28 days

InterventionSBMs/week (Mean)
Lubiprostone1.61
Placebo1.39

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Month 2 Stool Consistency Change From Baseline

0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls) (NCT00399542)
Timeframe: 28 days

Interventionunits on a scale (Mean)
Lubiprostone-0.50
Placebo-0.41

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Month 2 Symptom Relief

"3 = Significantly worse, -2 = Moderately worse,~1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved" (NCT00399542)
Timeframe: 28 days

Interventionunits on a scale (Mean)
Lubiprostone0.79
Placebo0.55

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Month 3 Abdominal Bloating Change From Baseline

0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe (NCT00399542)
Timeframe: 28 days

Interventionunits on a scale (Mean)
Lubiprostone-0.45
Placebo-0.35

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Month 3 Abdominal Pain Change From Baseline

0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe (NCT00399542)
Timeframe: 28 days

Interventionunits on a scale (Mean)
Lubiprostone-0.47
Placebo-0.35

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Month 3 Bowel Movement Rates Change From Baseline

(NCT00399542)
Timeframe: 28 days

InterventionBMs/week (Mean)
Lubiprostone1.17
Placebo0.97

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Month 3 Bowel Straining Change From Baseline

0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe (NCT00399542)
Timeframe: 28 days

Interventionunits on a scale (Mean)
Lubiprostone-0.63
Placebo-0.50

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Month 3 Quality of Life Change From Baseline

IBS-QOL questionnaire included 34 questions with 5 possible responses yielding the following sub-categories: dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationship Results range from 34 (low) to 100 (high); meaningful clinical improvement=14 point increase (NCT00399542)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
Lubiprostone17.3
Placebo13.4

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Month 3 Responder Rate

"Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:~Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month." (NCT00399542)
Timeframe: 28 days

Interventionpercentage of participants (Number)
Lubiprostone13.5
Placebo5.7

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Month 3 Spontaneous Bowel Movement Rates Change From Baseline

Any bowel movement not associated with rescue medication use (NCT00399542)
Timeframe: 28 days

InterventionSBMs/week (Mean)
Lubiprostone1.43
Placebo1.42

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Month 3 Stool Consistency Change From Baseline

0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls) (NCT00399542)
Timeframe: 28 days

Interventionunits on a scale (Mean)
Lubiprostone-0.49
Placebo-0.39

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Month 3 Symptom Relief

"3 = Significantly worse, -2 = Moderately worse,~1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved" (NCT00399542)
Timeframe: 28 days

Interventionunits on a scale (Mean)
Lubiprostone0.75
Placebo0.56

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Overall Responder Status

"Overall responder: monthly responder for at least 2 out of 3 months~Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:~Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month." (NCT00399542)
Timeframe: 12 weeks

Interventionpercentage of participants (Number)
Lubiprostone12.1
Placebo5.7

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Month 1 Stool Consistency Change From Baseline

0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls) (NCT00399542)
Timeframe: 28 days

Interventionunits on a scale (Mean)
Lubiprostone-0.47
Placebo-0.37

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Month 3 Constipation Severity Change From Baseline

0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe (NCT00399542)
Timeframe: 28 days

Interventionunits on a scale (Mean)
Lubiprostone-0.53
Placebo-0.42

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Frequency of Spontaneous Bowel Movements

Gathered as part of the daily electronic diary questions. (NCT00452335)
Timeframe: Weeks 2, 3, and 4

,,
Interventionspontaneous bowel movements per week (Mean)
Week 2Week 3Week 4
12 mcg BID2.592.602.68
12 mcg QD2.792.642.85
24 mcg BID3.513.582.99

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Pain Associated With SBMs

Pain associated with SBMs was assessed based on the following scale: 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain, and 4 = very severe pain. (NCT00452335)
Timeframe: Weekly, up to 4 weeks

,,
Interventionunits on a scale (Mean)
Week 1Week 2Week 3Week 4
12 mcg BID1.131.060.911.07
12 mcg QD1.560.720.880.82
24 mcg BID1.141.101.011.07

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Stool Consistency of SBMs

Stool consistency was captured using the Bristol Stool Form Scale: 1 = Separate hard lumps like nuts, 2 = Sausage shaped but lumpy, 3 = Like a sausage but with cracks on surface, 4 = Like a sausage or snake, smooth and soft, 5 = Soft blobs with clear-cut edges, 6 = Fluffy pieces with ragged edges, a mushy stool, and 7 = Watery, no solid pieces. (NCT00452335)
Timeframe: Weekly, up to 4 weeks

,,
Interventionunits on a scale (Mean)
Week 1Week 2Week 3Week 4
12 mcg BID3.202.903.312.96
12 mcg QD2.873.092.933.20
24 mcg BID3.143.223.594.01

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Straining Associated With SBMs

Bowel straining assessed based on the following scale: 0 = no straining, 1 = mild straining, 2 = moderate straining, 3 = severe straining, and 4 = very severe straining. (NCT00452335)
Timeframe: Weekly, up to 4 weeks

,,
Interventionunits on a scale (Mean)
Week 1Week 2Week 3Week 4
12 mcg BID1.341.221.111.31
12 mcg QD1.701.021.111.03
24 Mch BID1.441.301.160.97

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Treatment Effectiveness

Treatment effectiveness was assessed with the following scale: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, and 4 = extremely effective. (NCT00452335)
Timeframe: Weekly, up to 4 weeks

,,
Interventionunits on a scale (Mean)
Week 1Week 2Week 3Week 4
12 mcg BID1.61.71.81.8
12 mcg QD1.21.61.92.0
24 mcg BID1.72.01.81.9

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Abdominal Bloating

Abdominal bloating was assessed based on the following scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe. (NCT00452335)
Timeframe: Weekly, up to 4 weeks

,,
Interventionunits on a scale (Mean)
Week 1Week 2Week 3Week 4
12 mcg BID1.391.121.001.04
12 mcg QD1.161.080.820.96
24 mcg BID1.791.161.081.05

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Frequency of Spontaneous Bowel Movements

Gathered as part of the daily electronic diary questions. (NCT00452335)
Timeframe: Week 1

Interventionspontaneous bowel movements per week (Mean)
12 mcg QD2.47
12 mcg BID3.02
24 mcg BID3.84

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Abdominal Discomfort

Abdominal discomfort was assessed based on the following scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe. (NCT00452335)
Timeframe: Weekly, up to 4 weeks

,,
Interventionunits on a scale (Mean)
Week 1Week 2Week 3Week 4
12 mcg BID0.841.080.820.87
12 mcg QD1.160.930.901.05
24 mcg BID1.431.201.171.14

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Constipation Severity

Constipation severity was assessed based on the following scale 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe. (NCT00452335)
Timeframe: Weekly, up to 4 weeks

,,
Interventionunits on a scale (Mean)
Week 1Week 2Week 3Week 4
12 mcg BID1.691.431.361.28
12 mcg QD1.921.461.591.43
24 mcg BID1.791.401.381.59

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Frequency of Fecal Incontinence

As part of the daily diary, patients were asked to report the number of fecal incontinence episodes per day. (NCT00452335)
Timeframe: Weekly, up to 4 weeks

,,
Interventionepisodes of fecal incontinence per day (Mean)
Week 1Week 2Week 3Week 4
12 mcg BID0.220.210.160.17
12 mcg QD0.530.370.400.48
24 mcg BID0.030.050.010.02

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Number of Participants With the First Post-dose Spontaneous Bowel Movement Within 48 Hours Post-dose

The number of participants who experienced their first post-dose Spontaneous Bowel Movement within 24 and 48 hours after dosing started. (NCT00595946)
Timeframe: within 48 hours post-dose

,
InterventionParticipants (Count of Participants)
within 24 hourswithin 48 hours
Lubiprostone89138
Placebo65116

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Mean Weekly Spontaneous Bowel Movements at Week 8

Spontaneous bowel movements (SBMs) are defined as bowel movements without the aid of drugs. (NCT00595946)
Timeframe: at Week 8

InterventionSBMs/Week (Mean)
Placebo2.4
Lubiprostone3.2

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Number of Participants Classified as Responders

Number of participants who remained on treatment for at least 8 weeks, and reported at least 3 SBMs for at least half the weeks on study. (NCT00595946)
Timeframe: within 12 weeks

InterventionParticipants (Count of Participants)
Placebo87
Lubiprostone103

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Participant Reported Outcome of Treatment Effectiveness

Participants rated treatment effectiveness at the end of each treatment week during the study on a 5-point scale, where 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective. The 12 weekly scores were averaged. Higher scores mean the drug was more effective. (NCT00595946)
Timeframe: within 12 weeks

Interventionscore on a scale (Mean)
Placebo1.3
Lubiprostone1.6

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Mean Number of Spontaneous Bowel Movements (SBM) Per Week Within 12 Weeks

Average weekly SBM frequency was calculated from data collected from Week 1 through Week 12 (NCT00595946)
Timeframe: within 12 weeks

,
InterventionSBMs/Week (Mean)
at Week 12within 12 weeks
Lubiprostone2.82.7
Placebo2.22.1

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Mean Change From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity

"Measures collected over 12-week treatment period were averaged, and the score at baseline was subtracted from the score at week 12 to determine the change from baseline.~Straining scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse;~Stool consistency scale: 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) - middle scores are best;~Constipation severity scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse;~Abdominal bloating scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse;~Abdominal discomfort scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse;~Bowel habit regularity scale: 7-point scale, where 1 = very regular and 7 = very irregular - higher scores are worse" (NCT00595946)
Timeframe: within 12 weeks

,
Interventionscore on a scale (Mean)
StrainingStool consistencyConstipation severityAbdominal bloatingAbdominal discomfortBowel habit regularity
Lubiprostone-1.0-0.8-0.6-0.4-0.5-0.6
Placebo-0.6-0.5-0.4-0.4-0.3-0.5

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Change From Baseline in Mean Weekly SBM Frequency

For overall assessment of change, average weekly rating was calculated from data collected from Week 1 through Week 12. (NCT00597428)
Timeframe: Baseline, Week 12, and Weeks 1-12

,
InterventionSpontaneous Bowel Movements/Week (Mean)
Week 12Overall
Lubiprostone2.52.6
Placebo2.62.3

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Treatment Effectiveness

Treatment effectiveness scale: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective (NCT00597428)
Timeframe: Weeks 1-12

Interventionunits on a scale (Mean)
Placebo1.4
Lubiprostone1.5

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Responder Rate

Number of participants, who remained on treatment for at least 8 weeks, and reported response (>=3 SBMs) for at least 50% of weeks on study. (NCT00597428)
Timeframe: Up to 12 weeks

Interventionparticipants (Number)
Placebo100
Lubiprostone108

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Change From Baseline in Mean Weekly Spontaneous Bowel Movement (SBM) Frequency in Subjects Without Dose Reduction Prior to Week 8

(NCT00597428)
Timeframe: Baseline and Week 8

InterventionSpontaneous Bowel Movements/Week (Mean)
Placebo2.4
Lubiprostone2.6

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Mean Changes From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity

Ratings over 12-week treatment period were averaged and difference from baseline score calculated Straining scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Stool consistency scale: 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) Constipation severity scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Abdominal bloating scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Abdominal discomfort scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Bowel habit regularity scale: 7-point scale, where 1 = very regular and 7 = very irregular (NCT00597428)
Timeframe: Weeks 1-12

,
Interventionunits on a scale (Mean)
StrainingStool consistencyConstipation severityAbdominal bloatingAbdominal discomfortBowel habit regularity
Lubiprostone-0.8-0.6-0.6-0.5-0.5-0.8
Placebo-0.5-0.4-0.5-0.4-0.4-0.6

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First Post-dose SBM

The number of participants that experienced first post-dose SBM 24 and 48 hour of dose initiation. (NCT00597428)
Timeframe: 24 and 48 hours post-dose

,
Interventionparticipants (Number)
24 hours48 hours
Lubiprostone74136
Placebo64118

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The Overall Cleanliness of the Prep as Measured by the Ottawa Scale

Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0-4), as well as a global 3-point rating for overall colonic fluid (0-2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0-3, a good preparation 4-6, while scores higher than 7would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of colonic fluid (NCT00611442)
Timeframe: measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)

InterventionOttawa Score (Mean)
Amitiza4.8
Placebo6.2

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The Number of Polyps Detected on Examination

The number of colon polyps detected during the colonoscopy. (NCT00611442)
Timeframe: measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)

Interventionnumber of polyps (Number)
Amitiza48
Placebo44

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Patient Satisfaction With the Prep Measured by 5 Point Likert Scale

The participants completed a survey prior to the colonoscopy that graded their overall satisfaction with the bowel preparation. The subjects rated the survey questions on a 5-point Likert scale where 1 = severely distressing, 2=distressing, 3=bothersome, 4=mild, and 5=none. (NCT00611442)
Timeframe: measured after completion of the bowel preparation and prior to the colonoscopy, completed during the course of the study (approximately 4 month period)

Interventionlinkert scale (1-5) (Mean)
Amitiza3.7
Placebo3.2

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Procedure Time

Procedure time refers to the total length of time required to complete the colonoscopy (NCT00611442)
Timeframe: measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)

Interventionminutes (Mean)
Amitiza17.8
Placebo19.8

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Stool Consistency of Spontaneous Bowel Movements by Month

Participants rate each spontaneous bowel movement on a scale where 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) The highest score is 4, but the best score is 2. (NCT00620061)
Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

Interventionscore on a scale (Mean)
BaselineMonth 1Month 2Month 3Month 4Month 5Month 6Month 7Month 8Month 9
All Participants3.02.32.22.22.22.22.22.22.22.2

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Number of Participants Classified as Monthly Responders

"A weekly SBM frequency rate is calculated as (168 x Number of SBMs / Number of hours observed).~A participant with an SBM frequency rate between 3 and 4 was considered a moderate responder. A subject with an SBM frequency rate higher than 4 was considered a full responder. If a subject was a moderate responder or full responder for at least half the weeks in a month, then he or she was considered a monthly responder." (NCT00620061)
Timeframe: Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

InterventionParticipants (Count of Participants)
Month 1Month 2Month 3Month 4Month 5Month 6Month 7Month 8Month 9
All Participants322323291270259250239233202

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Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month

A Spontaneous Bowel Movement (SBM) is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication. (NCT00620061)
Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

InterventionWeekly SBMs (Mean)
BaselineMonth 1Month 2Month 3Month 4Month 5Month 6Month 7Month 8Month 9
All Participants1.44.94.95.05.05.05.05.15.35.2

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Mean Weekly Bowel Movements (BMs) Per Month

A Bowel Movement (BM) is defined as any BM (whether spontaneous or not) (NCT00620061)
Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

InterventionWeekly BMs (Mean)
BaselineMonth 1Month 2Month 3Month 4Month 5Month 6Month 7Month 8Month 9
All Participants2.45.05.05.25.15.15.15.25.45.3

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Constipation Severity by Month

"Participants rate the severity of their constipation on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.~The highest score is 4, but the best score is 0." (NCT00620061)
Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

Interventionscore on a scale (Mean)
BaselineMonth 1Month 2Month 3Month 4Month 5Month 6Month 7Month 8Month 9
All Participants2.41.51.51.51.51.41.41.41.41.4

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Bowel Habit Regularity by Month

"Participants rate their bowel habit regularity on a balanced scale of 1 to 7 where 1=Very Regular and 7=Very Irregular.~The highest score is 7, but the best score is 1." (NCT00620061)
Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

Interventionscore on a scale (Mean)
BaselineMonth 1Month 2Month 3Month 4Month 5Month 6Month 7Month 8Month 9
All Participants4.73.63.63.53.53.53.53.53.43.4

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Abdominal Discomfort by Month

"Participants rate their abdominal discomfort on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.~The highest score is 4, but the best score is 0." (NCT00620061)
Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

Interventionscore on a scale (Mean)
BaselineMonth 1Month 2Month 3Month 4Month 5Month 6Month 7Month 8Month 9
All Participants2.21.51.41.41.41.41.41.41.41.4

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Straining Associated With Spontaneous Bowel Movements by Month

Participants rate the straining associated with the SBM on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe The highest score is 4, and lower scores are better. (NCT00620061)
Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

Interventionscore on a scale (Mean)
BaselineMonth 1Month 2Month 3Month 4Month 5Month 6Month 7Month 8Month 9
All Participants2.71.71.71.61.71.61.71.71.61.6

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Abdominal Bloating by Month

"Participants rate their bloating on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.~The highest score is 4, but the best score is 0." (NCT00620061)
Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

Interventionscore on a scale (Mean)
BaselineMonth 1Month 2Month 3Month 4Month 5Month 6Month 7Month 8Month 9
All Participants2.21.61.51.51.51.51.51.51.51.5

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Mean Weekly Complete SBMs by Month

Participants rate each SBM as complete if their bowels feel completely empty after the SBM (NCT00620061)
Timeframe: Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

InterventionWeekly Complete SBMs (Mean)
Month 1Month 2Month 3Month 4Month 5Month 6Month 7Month 8Month 9
All Participants3.13.43.63.63.73.73.93.94.2

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Mean Weekly Complete BMs by Month

Participants rate each BM as complete if their bowels feel completely empty after the BM (NCT00620061)
Timeframe: Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

InterventionWeekly Complete BMs (Mean)
Month 1Month 2Month 3Month 4Month 5Month 6Month 7Month 8Month 9
All Participants3.13.43.63.73.83.83.83.94.1

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Treatment Effectiveness by Month

"Participants rate treatment effectiveness on a scale where 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective.~The highest and best score is 4." (NCT00620061)
Timeframe: Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

Interventionscore on a scale (Mean)
Month 1Month 2Month 3Month 4Month 5Month 6Month 7Month 8Month 9
All Participants2.12.12.22.22.22.22.32.32.3

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Endoscopist Evaluation of Colon Cleanliness in the Lubiprostone Group vs the Placebo Group

Endoscopists evaluated the quality of the colonoscopy preparation based on Ottawa bowel preparation scale. . The total score ranges from 0-14; score of 0 being perfect and score of 14 indicating solid stool in each colon segment and lot of fluid. Before using the scale for this trial, the endoscopists participated in a calibration exercise that involved 20 patients to ensure that they concurred on their interpretation of the scale. (NCT00645801)
Timeframe: within 12 hours of completing bowel prep

Interventionscore on a scale (Mean)
Look Alike Placebo in 4 Divided Doses Plus PEG and Electrolytes.1.38
Patient Received Both Lubiprostone in 4 Divided Doses and Golytely.1.24

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Tolerability of the Colon Cleansing Group in the Lubiprostone Group vs the Placebo Group

After completing the colonoscopy prep patients were asked to assess tolerability of the prep using a 5 point Likert scale with 1 being easy and 5 being unable to complete the prep (NCT00645801)
Timeframe: done at the time of colonoscopy

,
Interventionparticipants (Number)
easyTolerableslightly difficultextremely difficultunable to finish
Ingested 4 Tablets of Lubiprostone in Divided Doses + 1 Gallon of Polyethylene Glycol6151867
Ingested 4 Tablets of Placebo in Divided Doses + 1 Gallon of Polyethylene Glycol41425156

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Change in Volume of PEG From Beginning of Bowel Prep to That at Completion of the Colonoscopy Preparation in the Two Groups

Patients in the lubiprostone group and the placebo returned unused PEG after completing the prep for the colonoscopy. This was measured in liters and recorded. (NCT00645801)
Timeframe: amount of PEG at start of the study and that measured when the patient presented for their procedure.

Interventionliters (Mean)
Ingested 4 Tablets of Placebo in Divided Doses + 1 Gallon of Polyethylene Glycol0.79
Ingested 4 Tablets of Lubiprostone in Divided Doses + 1 Gallon of Polyethylene Glycol1.36

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Change in Patient Assessment of Constipation - Quality of Life

The second component of the PAC is the quality of life (QOL) component.The quality of life (QOL) component consists of five items that are rated on a 0-4 scale with higher scores indicating better QOL. Scores within the domains are averaged. (NCT00662363)
Timeframe: Baseline and day 7

Interventionunits on a scale (Mean)
Lubiprostone0.99
Senna.42

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Change in Patient Assessment of Constipation (PAC) - Symptoms (Sym)

Patient Assessment of Constipation (PAC) - Change in this measure was assessed. The PAC has previously been found to be a valid and reliable way to measure constipation symptoms and clinical course. The PAC has two components. The symptom (SYM) component is composed of 12 items with score range 0-4 with lower scores indicating improvement. Scores within the two domains were separately averaged. The PAC-SYM questionnaire has shown good concurrent and clinical validity for opioid-induced constipation in a number of pain populations and has demonstrative responsiveness to treatment. There are three symptom domains within the PAC-SYM: Abdominal symptoms (4 items), rectal symptoms (3 items) and stool symptoms (5 items). (NCT00662363)
Timeframe: Baseline and Day 7, after treatment completed (6 days of treatment)

Interventionunits on a scale (Mean)
Lubiprostone-0.22
Senna-0.29

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The Percentage of Patients That Received a Quality of Colonoscopy Preparation Rating of <=2 on a 5 Point Likert Scale.

The quality of colonoscopy preparations as rated by blinded colonoscopists on a 5-point Likert Scale where 1=excellent, 2=good, 3=fair, 4=poor, 5=inadequate. It was expected that at least 100 patients would complete the trial. (NCT00689026)
Timeframe: The outcome was measured at the completion of the colonscopy procedure. Average time to completion two hours

Interventionpercentage of patients (Number)
Experimental47
Control25

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Serum Phosphate

(NCT00706004)
Timeframe: baseline and 4 weeks

Interventionmg/dL (Mean)
Baseline4 weeks
Lubiprostone 24 Mcg Twice Daily3.83.7

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Serum Prealbumin

(NCT00706004)
Timeframe: baseline and 4 weeks

Interventionmg/dL (Mean)
Baseline4 weeks
Lubiprostone 24 Mcg Twice Daily22.621.5

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ALT

(NCT00706004)
Timeframe: baseline and 4 weeks

InterventionU/L (Mean)
Baseline4 weeks
Lubiprostone 24 Mcg Twice Daily25.123.8

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AST

(NCT00706004)
Timeframe: baseline and 4 weeks

InterventionU/L (Mean)
Baseline4 weeks
Lubiprostone 24 Mcg Twice Daily20.617.5

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Body Mass Index

(NCT00706004)
Timeframe: baseline, 2 weeks of treatment, 4 weeks of treatment

Interventionkg/m^2 (Mean)
Baseline2 weeks4 weeks
Lubiprostone 24 Mcg Twice Daily24.024.024.3

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Bristol Stool Scale Score

The Bristol Stool Scale is a scale used to rate the consistency of stool. Stool types are accompanied by a written description. There are seven types of stool that are scored from 1 to 7. A score of 1 or 2 indicates constipation; a score of 6 or 7, diarrhea. (NCT00706004)
Timeframe: 2-week run-in period, 2 weeks of treatment, 4 weeks of treatment

Interventionscores on a scale (Mean)
Baseline2 weeks4 weeks
Lubiprostone 24 Mcg Twice Daily3.43.63.3

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Number of Spontaneous Bowel Movements Per Week

(NCT00706004)
Timeframe: 2-week run-in period, 2-weeks of treatment, 4-weeks of treatment

Interventionbowel movements (Mean)
Baseline period2 weeks4 weeks
Lubiprostone 24 Mcg Twice Daily9.710.88.8

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Self Reported Adverse Effects at Each Study Visit

Adverse effects are problems reported by each study subject that they experienced during this clinical trial. Examples are headache and nausea. Study subjects were asked at each visit while on study drug to report any adverse affects that had occurred since the last visit. (NCT00706004)
Timeframe: During entire study period

Interventionparticipants (Number)
2 weeks4 weeks
Lubiprostone 24 Mcg Twice Daily53

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Serum Albumin

(NCT00706004)
Timeframe: baseline and 4 weeks

Interventiong/dL (Mean)
Baseline4 weeks
Lubiprostone 24 Mcg Twice Daily4.34.3

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Serum Bicarb

(NCT00706004)
Timeframe: baseline and 4 weeks

Interventionnmol/L (Mean)
Baseline4 weeks
Lubiprostone 24 Mcg Twice Daily23.825.2

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Serum BUN

(NCT00706004)
Timeframe: baseline and 4 weeks

Interventionmg/dL (Mean)
Baseline4 weeks
Lubiprostone 24 Mcg Twice Daily13.012.7

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Serum Calcium

(NCT00706004)
Timeframe: baseline and 4 weeks

Interventionmg/dL (Mean)
Baseline4 weeks
Lubiprostone 24 Mcg Twice Daily9.39.3

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Serum Chloride

(NCT00706004)
Timeframe: baseline and 4 weeks

Interventionnmol/L (Mean)
Baseline4 weeks
Lubiprostone 24 Mcg Twice Daily103.0104.3

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Serum Creatinine

(NCT00706004)
Timeframe: baseline and 4 weeks

Interventionmg/dL (Mean)
Baseline4 weeks
Lubiprostone 24 Mcg Twice Daily0.790.84

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Serum Glucose

(NCT00706004)
Timeframe: baseline and 4 weeks

Interventionmg/dL (Mean)
Baseline4 weeks
Lubiprostone 24 Mcg Twice Daily150.3131.8

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Serum Magnesium

(NCT00706004)
Timeframe: baseline and 4 weeks

Interventionmg/dL (Mean)
Baseline4 weeks
Lubiprostone 24 Mcg Twice Daily2.02.0

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Serum Potassium

(NCT00706004)
Timeframe: baseline and 4 weeks

Interventionnmol/L (Mean)
Baseline4 weeks
Lubiprostone 24 Mcg Twice Daily4.44.4

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Serum Vitamin E

(NCT00706004)
Timeframe: baseline and 4 weeks

Interventionmg/L (Mean)
Baseline4 weeks
Lubiprostone 24 Mcg Twice Daily6.67.7

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Serum Vitamin D

(NCT00706004)
Timeframe: baseline and 4 weeks

Interventionng/mL (Mean)
Baseline4 weeks
Lubiprostone 24 Mcg Twice Daily25.325.3

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Serum Vitamin A

(NCT00706004)
Timeframe: baseline and 4 weeks

Interventionug/dL (Mean)
Baseline4 weeks
Lubiprostone 24 Mcg Twice Daily41.342.7

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Patient Assessment of Constipation Symptoms

The Patient Assessment of Constipation - Symptom (PAC-SYM) survey is a 1-page 12-item tool that measures a patient's assessment of constipation symptoms. The items are in Likert scale format and address the severity of stool, rectal and abdominal symptoms over the past 2 weeks. Items are scored on a scale of 0 to 4, with 4 indicating the most severe. To compute the overall score, the scores of the non-missing items are summed and this is divided by the total number of non-missing items (overall score range, 0 to 4). (NCT00706004)
Timeframe: 2-week run-in period, 2 weeks of treatment, 4 weeks of treatment

Interventionscores on a scale (Mean)
Baseline2 weeks4 weeks
Lubiprostone 24 Mcg Twice Daily1.180.540.44

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Serum Sodium

(NCT00706004)
Timeframe: baseline, 4 weeks

Interventionnmol/L (Mean)
Baseline4 weeks
Lubiprostone 24 Mcg Twice Daily137.4139.2

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Small Bowel Transit

Small bowel transit time (NCT00746395)
Timeframe: Duration of the test - 8 hours

InterventionMinutes (Mean)
Lubiprostone 24mcg Single Dose188.1
Sugar Pill218.9

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Complete Small Bowel Transit

Percent of subjects with capsule passage through small bowel (NCT00746395)
Timeframe: 8 hours

Interventionpercentage of subjects with passage (Number)
Lubiprostone 24mcg Single Dose75
Sugar Pill95

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Small Intestinal Bacterial Overgrowth (SIBO)

SIBO was measured before and after treatment. (NCT00844831)
Timeframe: 28 days

Interventionparticipants (Number)
Before Open Label Lubiprostone8
After Open Label Treatment9

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Presence of Small Intestinal Bacterial Overgrowth

Percent of patients with bacterial overgrowth before and after treatment. (NCT00844831)
Timeframe: 28 days

InterventionParticipants (Count of Participants)
Before Open Label Lubiprostone8
After Open Label Treatment9

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Change From Baseline to End of Study

Global impression of change, stool diary, visual analog scale of improvement, UPDRS rating scale and constipation questionnaires. The primary efficacy data will be analyzed using Student's t-test with unequal variances as the difference from baseline in SBM comparing cases and controls, using last observation carried forward for missing data in the intent-to-treat population. (NCT00908076)
Timeframe: Baseline to end of study

InterventionPercentage of participants (Number)
Amitiza64
Placebo18.5

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Patient Satisfaction With the Prep Measured by 5 Point Likert Scale

patient satisfaction based on a Likert Scale from 0-5 (5 being completely satisfied and 0 being not satisfied) (NCT00953017)
Timeframe: measured at check in to colonoscopy

Interventionunits on a scale (Mean)
Miralax Plus Amitiza3.8
Miralax Plus Dulcolax4.1
Miralax4.0
Golytely (Polyethylene Glycol)3.2

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Polyps Detected

Number of polyps (NCT00953017)
Timeframe: measured at the time of colonoscopy

Interventionpolyps (Number)
Miralax Plus Amitiza128
Miralax Plus Dulcolax92
Miralax90
Golytely (Polyethylene Glycol)101

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Procedure Time

total colonoscopy procedure time (NCT00953017)
Timeframe: measured at the time of colonoscopy

Interventionminutes (Mean)
Miralax Plus Amitiza21.3
Miralax Plus Dulcolax19.3
Miralax20
Golytely (Polyethylene Glycol)18.3

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The Cleanliness of the Prep as Measured by the Ottawa Scale

Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0-4), as well as a global 3-point rating for overall colonic fluid (0-2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0-3, a good preparation 4-6, while scores higher than 7 would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of colonic fluid. (NCT00953017)
Timeframe: measured at the time of colonoscopy

InterventionOttawa Scale (Mean)
Miralax Plus Amitiza6.3
Miralax Plus Dulcolax6.8
Miralax6.9
Golytely (Polyethylene Glycol)5.1

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Colonic Compliance

"Colonic compliance is a measure of the stiffness of the colon, that is, what pressure was needed to reach half the maximum volume of the colon.~After the barostat catheter was inserted in the colon, the catheter was connected to a barostat machine. After an initial conditioning distension to 20 mm Hg, colonic compliance was measured by step-wise inflation with increments of 4 mm Hg up to 64 mm Hg. Colonic compliance was analyzed by a validated linear interpolation method. The pressure at half maximum volume serves as a summary of colonic compliance." (NCT00953043)
Timeframe: 1 hour after third dose of lubiprostone or placebo, on Day 3

Interventionmm Hg (Mean)
Lubiprostone16.60
Placebo16.50

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Median Pressure When Pain Sensation Was First Reported by 50% of Participants

The sensory threshold for first perception of pain was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mmg Hg. During this assessment participants were asked to report when they had the first perception of pain. The investigator recorded the threshold pressure at which the participants reported this sensation. (NCT00953043)
Timeframe: approximately 45 min after colonic tube placement, on Day 3

Interventionmm Hg (Median)
Lubiprostone44
Placebo40

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Postprandial Colonic Tone

Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon). (NCT00953043)
Timeframe: 30 minutes after standard meal, on Day 3

InterventionmL (Mean)
Lubiprostone78.69
Placebo75.01

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Median Pressure When First Sensation Was Reported by 50% of Participants

The sensory threshold for first sensation was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mmg Hg. During this assessment participants were asked to report when they had the first sensation. The investigator recorded the threshold pressure at which the participants reported this sensation. (NCT00953043)
Timeframe: approximately 45 min after colonic tube placement, on Day 3

Interventionmm Hg (Median)
Lubiprostone16
Placebo12

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Median Pressure When Gas Sensation Was First Reported by 50% of Participants

The sensory threshold for first perception of gas was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mmg Hg. During this assessment participants were asked to report when they had the first perception of gas. The investigator recorded the threshold pressure at which the participants reported this sensation. (NCT00953043)
Timeframe: approximately 45 min after colonic tube placement, on Day 3

Interventionmm Hg (Median)
Lubiprostone28
Placebo24

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Gas Sensation Ratings in Response to Colonic Distensions at 32 mm Hg Above Baseline Operating Pressure

Gas sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no gas sensation and 100 mm for extreme gas sensation. The investigator measures the mark made by the participant in mm and records this for the value of gas sensation. (NCT00953043)
Timeframe: approximately 1 hour after colonic tube placement, on Day 3

Interventionmm (Mean)
Lubiprostone51.4
Placebo54.6

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Fasting Colonic Tone

Colonic tone is a measurement of the volume of the colon. Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon). (NCT00953043)
Timeframe: 30 minutes after the colonic tube placement, on Day 3

InterventionmL (Mean)
Lubiprostone101.9
Placebo112.8

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Pain Sensation Ratings in Response to Colonic Distension at 32 mm HG Above Baseline Operating Pressure

Pain was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain. (NCT00953043)
Timeframe: approximately 1 hour after colonic tube placement, on Day 3

Interventionmm (Mean)
Lubiprostone55.2
Placebo55.8

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Relief of Constipation Defined by Modified ROME Criteria

Subjects will report symptoms by questionnaire (NCT01096290)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Lubiprostone 24mcg BID for 30 Days7
Placebo7

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Change in Motility Pattern of the Small Bowel and Colon From Baseline as Defined by the Motility Index

Change in the motility index defined as the natural log [(sum of pressure amplitudes times the number of contractions) + 1] for the small bowel and colon based on a measurement done at baseline and then again at 3 weeks into the intervention. (NCT01162863)
Timeframe: 21-28 days

,,
Interventionunits on a scale (Mean)
Small bowel motility indexColon motility index
Lubiprostone 24 mcg QD-0.01-1.32
Lubiprostone 8 mcg BID0.60.17
Placebo0.06-0.34

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Change in Small Bowel pH and Colon pH From Baseline

Change in the mean pH of the small intestine and colon based on a measurement done at baseline and then again at 3 weeks into the intervention. (NCT01162863)
Timeframe: 21-28 days

,,
InterventionpH (Mean)
Small bowel pHColon pH
Lubiprostone 24 mcg QD0.23-0.07
Lubiprostone 8 mcg BID0.240.27
Placebo0.18-0.03

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Change in Gastric Emptying Time, Small Bowel Transit Time, Colon Transit Time and Whole Gut Transit Time From Baseline

Change in gastric emptying time, small bowel transit time, colon transit time and whole gut transit time measured in hours based on a measurement done at baseline and then again at 3 weeks into the intervention within each treatment arm (NCT01162863)
Timeframe: 21-28 days

,,
Interventionhours (Mean)
Gastric emptying timeSmall bowel transit timeColon transit timeWhole gut transit time
Lubiprostone 24 mcg QD6.520.15-4.43-1.74
Lubiprostone 8 mcg BID-0.16-0.0012.591.67
Placebo5.490.25.7510.32

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Efficacy, Measured by the Average Number of Spontaneous Bowel Movements (SBMs) Per Week

The average number of spontaneous bowel movements calculated per week from baseline to 8 weeks was recorded. The number of spontaneous bowel movements was recorded by the subjects in a daily stool diary and the weekly average was calculated. Spontaneous bowel movements are bowel movements within a 24 hour period independent of rescue medication use within the previous week. (NCT01170039)
Timeframe: 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks

,
Interventionspontaneous bowel movements (Mean)
1 week2 weeks3 weeks4 weeks5 weeks6 weeks7 weeks8 weeks
Lubiprostone4.853.815.764.125.284.524.655.30
Placebo1.402.413.112.483.033.233.462.63

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Change in Scores on the Patient Assessment of Constipation Quality of Life (PAC-QOL) Questionnaire

The difference in the scores on the self-reported Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire. The quality of life is measured by the by the overall scores on the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire, a validated 28-item questionnaire measuring quality of life as it pertains to constipation. The 28 items are grouped into four subscales, 1) worries and concerns, 2) physical discomfort, 3) psychosocial discomfort, and 4) satisfaction. A 5-point Likert response scale, ranging from 0 (Not at all/None of the time) to 4 (Extremely/ All of the time), is used. The subscale scores vary from 0 to 4 and the total (global) score ranges from 0 to 4. A lower score indicates better quality of life (QOL). (NCT01170039)
Timeframe: Screening, 8 weeks

,
Interventionscores on a scale (Mean)
Global ScorePhysical discomfortPsychosocial discomfortWorries and concernsSatisfaction
Lubiprostone-0.91-1.08-0.72-0.88-1.28
Placebo1.19-1.22-1.13-1.18-1.26

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Number of Subjects With Daily Abdominal Discomfort

The number of subjects experiencing abdominal discomfort was recorded weekly. (NCT01170039)
Timeframe: 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks

,
Interventionparticipants (Number)
1 week (n=33; n=38)2 weeks (n=32; n=37)3 weeks (n=29; n=33)4 weeks (n=30; n=33)5 weeks (n=27; n=33)6 weeks (n=26; n=30)7 weeks (n=23; n=29)8 weeks (n=22; n=29)
Lubiprostone2417171613201411
Placebo2620212218141615

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Efficacy, Measured by the Duration of Colonic Transit Time as Measured by the SmartPill pH Capsule

The duration of colonic transit time in hours was measured by the SmartPill pH Capsule. Colonic transit time is the time interval from the cecal entry of the capsule to anal expulsion and was measured in hours. (NCT01170039)
Timeframe: Baseline, 4 weeks

,
Interventionhours (Mean)
Baseline n=30; n=324 weeks n=24; n=22
Lubiprostone45.336.2
Placebo40.947.7

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Change in Methane Production

Change in the mean area under the curve of the breath hydrogen and methane gas profiles in parts per million, from time 0 to 120 minutes, between baseline versus mean area under the curve at the end of study. (NCT01190020)
Timeframe: Baseline and 1 month

Interventionparts per million*minutes (Mean)
Lubiprostone10645
Placebo14635

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Peak Methane Value

The peak methane value measured during the baseline breath study will be compared with the peak methane obtained at the end of study breath test (NCT01190020)
Timeframe: Baseline and 1 month

Interventionparts per million (Mean)
Lubiprostone51.3
Placebo70.5

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Percentage Change in the Colonic Transit Time

Percentage change of colonic transit time between the baseline colonic transit study and the colonic transit study at the end of study (NCT01190020)
Timeframe: Baseline and 1 month

Interventionpercent (Mean)
Lubiprostone0.23
Placebo0.48

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Stool Frequency (Complete Spontaneous Bowel Movements)

change in mean stool frequency (delta) between baseline week and final week of study (NCT01190020)
Timeframe: Baseline and 1 month

Interventionbowel movements per week (Mean)
Lubiprostone3.71
Placebo0.85

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Number of Spontaneous Bowel Movements in Patients With Multiple Sclerosis (MS)-Associated Constipation Per Day.

Number of of lubiprostone 24 mcg twice daily on spontaneous bowel movements (SBM) in patients with multiple sclerosis (MS)-associated constipation per day. Hypothesis: Lubiprostone-treated patients will have more SBM's than placebo-treated patients. (NCT01236534)
Timeframe: 21 days

Interventionspontaneous bowel movements (Mean)
Lubiprostone3.4
Sugar Pill3.2

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Number of Participants With Diarrheic Events.

To determine the safety of lubiprostone based on adverse event (AE) type, frequency, and severity. Hypothesis: AE type, frequency, and severity will be comparable in lubiprostone and placebo treated patients. (NCT01236534)
Timeframe: 21 days

Interventionparticipants (Number)
Lubiprostone8
Sugar Pill2

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Number of Participants Who Experienced First SBM Within 48 Hours After Dose Initiation

(NCT01298219)
Timeframe: within 48 hours post-dose

,
InterventionParticipants (Count of Participants)
within 24 Hourswithin 48 Hours
Lubiprostone110157
Placebo84134

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Number of SBMs Per Week at Week 8

(NCT01298219)
Timeframe: at Week 8

InterventionSBMs/week (Mean)
Lubiprostone2.9
Placebo2.5

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Number of SBMs Per Week at Week 12

(NCT01298219)
Timeframe: at Week 12

InterventionSBMs/week (Mean)
Lubiprostone3.1
Placebo2.7

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Number of Participants Classified as Treatment Responders Within 12 Weeks

Spontaneous bowel movement (SBM) is defined as any BM that does not occur within 24 hours after use of rescue medication. To be classified as responders, participants are required to demonstrate at least moderate response (≥ 1 SBM improvement over baseline SBM frequency) for all treatment weeks for which observed data are available, and must additionally demonstrate a full response (≥ 3 SBMs per week) for at least 9 of the 12 treatment weeks. (NCT01298219)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Lubiprostone59
Placebo41

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Number of SBMs Per Week Overall

Overall is defined as the length of time from first dose to last follow-up within 2 weeks after last dose. (NCT01298219)
Timeframe: within 14 weeks

InterventionSBMs/week (Mean)
Lubiprostone4.3
Placebo3.7

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Change of Mucus and Mucin Secretion in Patients With Chronic Constipation and in Controls.

The rate of mucus and mucin secretion(mg/hr) will be measured in gastric juice aspirated in basal conditions and during stimulation with pentagastrin after 1 week of therapy with lubiprostone (Active Comparator) and compared with 1 week of placebo administration (Placebo Comparator). (NCT01447849)
Timeframe: Measured after 1 week of lubiprostone and 1 week of placebo with 1 week of washout period in between.

,
Interventionmg/hour (Mean)
Mucus Secretion in Chronic Constipation SubjectsMucus Secretion in ControlsMucin Secretion in Chronic Constipation SubjectsMucin Secretion in Controls
Lubiprostone 24 mcg BID26022999100
Placebo1331615469

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Change in Viscoelasticity of Gastric Secretion in Controls and Patients With Chronic Constipation.

The viscoelasticity of gastric mucus(centipoises) was measured in gastric juice aspirated in basal conditions and during stimulation with pentagastrin after 1 week of therapy with lubiprostone (Active Comparator) and compared with 1 week of placebo administration (Placebo Comparator). (NCT01447849)
Timeframe: Measured after 1 week of lubiprostone therapy and compared to 1 week of placebo with 1 week of washout in between.

,
InterventionCentipoises (Mean)
Basal viscosity in chronic constipation subjectsBasal viscosity in controlsPentagastrin-Stimulated viscosity in CCPentagastrin-Stimulated viscosity in Controls
Lubiprostone 24 mcg Bid21.6112.7814.9610.58
Placebo6.349.414.597.84

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Gastric Emptying

gastric emptying was measured before and after 7 days of treatment.at set times (2 and 4 hours post eating a radio-labeled meal) (NCT01460225)
Timeframe: Day 1 and Day 7

,
Interventionpercent meal retention (Mean)
2 Hours after meal4 Hours after meal
Post Treatment With Lubiprostone0.3840.051
Prior to Treatement With Lubiprostone0.270.04

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Changes in Number of Bowel Movements in Chronically Constipated Patients After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day (BID).

(NCT01469819)
Timeframe: Measured at baseline and 2 weeks after baseline

Interventionnumber per week (Mean)
Bowel Movements before treatmentBowel Movements after treatment
All Participants1.94.6

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Changes in Number of Bowel Movements Per Week Changes GE, SB, LB and WG Transit Times Measured by SmartPill in Chronically Constipated Patients Treated for 2 Weeks With Lubiprostone 24mcg Twice a Day.

(NCT01469819)
Timeframe: Measured at baseline and 2 weeks after baseline.

,
Interventionnumber per week (Mean)
Bowel Movements before treatmentBowel Movements after treatment
Non-Responders2.13.0
Responders1.86.0

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Changes in Time of GE, SB, LB and WG Transits Measured by SmartPill After 2 Weeks of Lubiprostone 24mcg BID in Chronically Constipated Patients.

Changes in Time of GE, SB, LB and WG transits measured by SmartPill after 2 weeks of lubiprostone 24mcg BID in chronically constipated patients who increased stool frequency to ≥ 2 times increase per week vs. patients who increased stool frequency < 2 times increase per week. (NCT01469819)
Timeframe: Measured at baseline and 2 weeks after baseline.

,
InterventionHours (Mean)
Gastric Emptying Time before treatmentSmall Bowel Transit Time before treatmentSmall & Large Bowel Transit Time before treatmentWhole Gut Transit Time before treatmentGastric Emptying Time after treatmentSmall Bowel Transit Time after treatmentSmall & Large Bowel Transit Time after treatmentWhole Gut Transit Time after treatment
Non-Responders3.94.570.175.06.44.557.063.4
Responders9.67.245.955.511.64.432.043.7

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Elimination of Small Intestine Bacterial Overgrowth (SIBO) in Chronically Constipated Patients Treated With Lubiprostone 24mcg Twice a Day for 2 Weeks.

(NCT01469819)
Timeframe: Measured at baseline and 2 weeks after baseline.

Interventionparticipants (Number)
SIBO (+) participants before treatmentSIBO (+) participants after treatmentSIBO (+)→SIBO (-) participants after treatments
SIBO (+)17107

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Time Reduction (Hours and Minutes) of Gastric Emptying (GE), Small Bowel (SB), Large Bowel (LB) and Whole Gut (WG) Transits Measured by SmartPill in Chronically Constipated Patients Before and After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day.

The change in transit time (TT), in hours and minutes, of gastric emptying (GE), small bowel (SB), large bowel (LB) and whole gut (WG) measured by SmartPill in 29 patients with chronic constipation after taking lubiprostone 24 micrograms twice a day (BID) for 2 weeks. (NCT01469819)
Timeframe: Measured at baseline and 2 weeks after baseline.

InterventionHours (Mean)
Gastric Emptying Time before treatmentSmall Bowel Transit Time before treatmentSmall & Large Bowel Transit Time before treatmentWhole Gut Transit Time before treatmentGastric Emptying Time after treatmentSmall Bowel Transit Time after treatmentSmall & Large Bowel Transit Time after treatmentWhole Gut Transit Time after treatment
All Participants7.05.956.764.29.34.543.252.5

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Changes in Gut Microbial Translocation (Zonulin)

Summary difference of participant's median Zonulin MT marker change at week 4 from baseline aggregate median values. (NCT01839734)
Timeframe: Baseline and 4 weeks

,
Interventionng/ML (Median)
Zonulin BaselineZonulin Week 4Zonulin 4 Week Summary Difference
Control3.240.98-1.80
Lubiprostone11.060.05

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Changes in Systemic Inflammation (IL-6)

Summary difference of participant's median IL-6 inflammation marker change at week 4 from baseline aggregate median values. (NCT01839734)
Timeframe: Baseline and 4 weeks

,
Interventionpg/mL (Median)
IL-6 BaselineIL-6 Week 4IL-6 4 Week Summary Difference
Control1.722.65-0.68
Lubiprostone1.461.67-0.12

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Changes in Systemic Inflammation (hsCRP)

Summary difference of participant's median hsCRP inflammation marker change at week 4 from baseline aggregate median values (NCT01839734)
Timeframe: Baseline and 4 weeks

,
Interventionpg/mL (Median)
hsCRP BaselinehsCRP Week 4hsCRP 4 Week Summary Difference
Control21.4822.976.80
Lubiprostone25.9927.720.51

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Changes in Gut Microbial Translocation (sCD163)

Summary difference of participant's median sCD163 MT marker change at week 4 from baseline aggregate median values (NCT01839734)
Timeframe: Baseline and 4 weeks

,
Interventionpg/mL (Median)
sCD163 BaselinesCD163 Week 4sCD163 4 Week Summary Difference
Control51.7556.744.99
Lubiprostone73.0969.96-2.56

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Changes in Gut Microbial Translocation (sCD14)

Summary difference of participant's median sCD14 MT marker change at week 4 from baseline aggregate median values (NCT01839734)
Timeframe: Baseline and 4 weeks

,
Interventionpg/mL (Median)
sCD14 BaselinesCD14 Week 4sCD14 4 Week Summary Difference
Control12370.3011345.27-930.48
Lubiprostone10807.0611177.92247.20

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Changes in Gut Microbial Translocation (iFABP)

Summary difference of participant's median iFABP MT marker change at week 4 from baseline aggregate median values (NCT01839734)
Timeframe: Baseline and 4 weeks

,
Interventionpg/mL (Median)
iFABP BaselineiFABP Week 4iFABP 4 Week summary difference
Control125.36111.7314.47
Lubiprostone145.76151.5-9.34

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Changes in Peripheral CD4+

Summary difference of participant's median CD4+ change at week 4 from baseline aggregate median values (NCT01839734)
Timeframe: Baseline and 4 weeks

,
Interventioncells/mm^3 (Median)
CD4+ BaselineCD4+ Week 4CD4+ 4 Week Summary Difference
Control329.5230-17.5
Lubiprostone3333395.5

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Number of Participants With Adverse Events During Study Period

Safety monitoring, defined as Grade ≥ 2 signs and symptoms, Grade ≥ 2 laboratory abnormalities, and other serious adverse events (SAEs) not otherwise specified. (NCT01839734)
Timeframe: 4 weeks

InterventionParticipants (Count of Participants)
Lubiprostone0
Control0

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Overall Straining at Week 1

Bowel straining was rated on a scale of 0 to 4 (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe). (NCT01993875)
Timeframe: Week 1

InterventionUnits on a scale (Mean)
Lubiprostone1.8
Placebo1.9

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Consistency of SBMs at Week 1

Stool consistency was rated according to the 7-point Bristol Stool Form Scale: Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. (NCT01993875)
Timeframe: at Week 1

Interventionscore on a scale (Mean)
Lubiprostone3.2
Placebo2.4

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Mean Change From Baseline in Stool Consistency at Week 1

Stool consistency was rated according to the 7-point Bristol Stool Form Scale: Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. The change from baseline was calculated as post-treatment value (mean) minus the baseline value (mean). (NCT01993875)
Timeframe: Baseline and Week 1

InterventionUnits on a scale (Mean)
Lubiprostone1.8
Placebo1.9

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Mean Change From Baseline in Straining at Week 1

Bowel straining was rated as 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The change from baseline was calculated as post-treatment value minus the baseline value. (NCT01993875)
Timeframe: Week 1

InterventionUnits on a scale (Mean)
Lubiprostone-1.1
Placebo-0.8

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Number of Spontaneous Bowel Movements (SBMs) Within 1 Week

SBM is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication. (NCT01993875)
Timeframe: within 1 week

Interventionnumber of SBMs (Mean)
Lubiprostone4.6
Placebo4.0

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Overall Stool Consistency at Week 1

Overall stool consistency was rated according to the 7-point Bristol Stool Form Scale: Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. (NCT01993875)
Timeframe: at Week 1

Interventionscore on a scale (Mean)
Lubiprostone3.3
Placebo3.0

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Number of Participants Classified as Overall Responders at Week 12

An overall responder is defined as a participant who qualified as a weekly responder for 9 of the 12 treatment weeks, with durability demonstrated by at least 3 of the responder weeks occurring during the last 4 weeks of the treatment period. A weekly responder is defined as a participant who has at least 3 spontaneous bowel movements during the week, and at least one more than at baseline. (NCT02042183)
Timeframe: at Week 12

InterventionParticipants (Count of Participants)
Lubiprostone76
Placebo28

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Mean Number of SBMs Observed Each Week for 12 Weeks

Data provided is based on observed cases. Baseline is the average of the 2 weeks before being randomized. Participants are summarized by actual dose received after week 1. (NCT02042183)
Timeframe: within 12 Weeks

,
InterventionSpontaneous bowel movements (Mean)
at Baselineat Week 1at Week 2at Week 3at Week 4at Week 5at Week 6at Week 7at Week 8at Week 9at Week 10at Week 11at Week 12
Lubiprostone1.402.652.682.852.942.912.912.812.942.832.682.782.90
Placebo1.422.502.692.592.692.682.652.752.642.372.402.602.75

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Median Monthly Score on a Stool Consistency Scale Associated With Observed SBMs

Stool consistency is rated on a 5-Point Stool Consistency Scale, where 1=normal and 5=very hard. Higher scores mean a worse outcome. (NCT02138136)
Timeframe: within 9 months

Interventionscore on a scale (Median)
Month 1Month 2Month 3Month 4Month 5Month 6Month 7Month 8Month 9
All Participants2.802.752.782.782.832.832.872.902.89

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Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month

Spontaneous bowel movements are defined as bowel movements without the aid of drugs. (NCT02138136)
Timeframe: within 9 months

InterventionWeekly SBMs (Median)
Month 1Month 2Month 3Month 4Month 5Month 6Month 7Month 8Month 9
All Participants2.662.752.702.752.742.502.632.632.50

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Median Monthly Score on a 5-point Straining Scale Associated With Observed SBMs

Straining during observed SBMs is rated on a 5-point scale where 1=no straining and 5=extreme straining. A higher value is worse. (NCT02138136)
Timeframe: within 9 months

Interventionscore on a scale (Median)
Month 1Month 2Month 3Month 4Month 5Month 6Month 7Month 8Month 9
All Participants1.191.251.141.171.191.131.001.001.00

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Median Monthly Score on a 4-point Pain Scale for Observed Abdominal Pain

Abdominal pain was rated on a scale from 1 (no pain) to 4 (very severe pain). A higher score means a worse outcome. (NCT02138136)
Timeframe: within 9 months

Interventionscore on a scale (Median)
Month 1Month 2Month 3Month 4Month 5Month 6Month 7Month 8Month 9
All Participants1.000.990.900.850.840.820.750.850.79

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Complete Spontaneous Bowel Movement (CSBM) Response

The primary endpoint is based on the number of subjects who are weekly responders for at least 9 out of 12 weeks, with at least 3 of these weeks occurring in the last 4 weeks of treatment. A weekly responder is a subject who has ≥ 3 CSBMs and an increase from baseline of > 1 CSBM in that week. (NCT02481947)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
BLI400 Laxative47
Lubiprostone56

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Number of Participants Classified as a Monthly Responder for IBS Symptoms

A participant who is a weekly responder for IBS symptoms for at least 2 of the 4 weeks in the preceding month is classified as a monthly responder for IBS symptoms. (NCT02544152)
Timeframe: within 3 months

,
InterventionParticipants (Count of Participants)
Month 1Month 2Month 3
Lubiprostone161815
Placebo212017

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Number of Participants Classified as a Monthly Responder for Abdominal Pain

A monthly responder for abdominal pain is defined as a participant who is a weekly responder for abdominal pain at least 2 of 4 weeks in the preceding month. (NCT02544152)
Timeframe: within 3 months

,
InterventionParticipants (Count of Participants)
Month 1Month 2Month 3
Lubiprostone141613
Placebo121615

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Number of Participants Classified as a Weekly Responder for Irritable Bowel Syndrome (IBS) Symptoms

A participant who achieves adequate relief of IBS symptoms during the preceding week is classified as a weekly responder for IBS symptoms. (NCT02544152)
Timeframe: within 12 weeks

,
InterventionParticipants (Count of Participants)
Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12
Lubiprostone9141520191717201415146
Placebo14161821221916171815184

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Number of Participants Classified as a Weekly Responder for Stool Consistency

A weekly responder for stool consistency is defined as a participant having at least 50% reduction from baseline in percentage of days with extreme stool consistency for a given week. (NCT02544152)
Timeframe: within 12 weeks

,
InterventionParticipants (Count of Participants)
Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12
Lubiprostone12111010979951068
Placebo5657118866878

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Number of Participants Classified as a Monthly Responder for Stool Consistency

A monthly responder for stool consistency is defined as a participant who is a weekly responder for stool consistency at least 2 of 4 weeks in the preceding month. (NCT02544152)
Timeframe: within 3 months

,
InterventionParticipants (Count of Participants)
Month 1Month 2Month 3
Lubiprostone1297
Placebo3127

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Number of Participants Classified as an Overall Responder for Abdominal Pain

An overall responder for abdominal pain is defined as a participant who is a weekly responder for at least 75% of observed treatment weeks. (NCT02544152)
Timeframe: within 12 weeks

InterventionParticipants (Count of Participants)
Placebo10
Lubiprostone11

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Number of Participants Classified as an Overall Responder for Stool Consistency

An overall responder for stool consistency is defined as a participant who qualifies as a weekly responder for stool consistency for at least 75% of observed treatment weeks. (NCT02544152)
Timeframe: within 3 months

InterventionParticipants (Count of Participants)
Placebo0
Lubiprostone3

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Number of Participants Classified as an Overall Responder for IBS Symptoms

A participant who is a weekly responder for IBS symptoms for at least 75% of observed treatment weeks is classified as an overall responder for IBS symptoms. (NCT02544152)
Timeframe: within 3 months

InterventionParticipants (Count of Participants)
Placebo11
Lubiprostone10

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Number of Participants Classified as a Weekly Responder for Abdominal Pain

"Participants rate their pain on a pain intensity scale where 0=no pain and 10=worst pain. A higher score means the pain is worse.~A weekly responder for abdominal pain is defined as a participant reporting ≥ 30% reduction from baseline in average of 24-hour worst abdominal pain scores for the preceding week." (NCT02544152)
Timeframe: within 12 weeks

,
InterventionParticipants (Count of Participants)
Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12
Lubiprostone7812191815141815121412
Placebo71311131516141113151410

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Percentage of Participants Who Had a SBM Within 24 Hours After the First Dose of Study Medication

A SBM is defined as any BM that does not occur within 24 hours after rescue medication use. Percentage of participants who had a SBM within 24 hours after the first dose was assessed and derived from the data on SBMs collected in the participant diary. (NCT02651155)
Timeframe: Up to 24 hours after the first dose of study medication

Interventionpercentage of participants (Number)
Placebo35.4
Lubiprostone 24 μg46.7

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Spontaneous Bowel Movement (SBM) Frequency at Week 1

A SBM is defined as any bowel movement (BM) that does not occur within 24 hours after rescue medication use (laxative, suppository, or enema). SBM frequency data was collected in a diary. Participants were given a diary to complete at home where they recorded the date and time of each BM. (NCT02651155)
Timeframe: Week 1

InterventionSBMs/week (Mean)
Placebo3.6
Lubiprostone 24 μg5.0

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Mean Degree of Straining Score

For each participant, the mean degree of straining was averaged for all SBMs in a given week. The degree of straining for each SBM was collected in the participant diary. The degree of straining is scored on a 5-point scale where: 0=No straining, 1=Mild straining, 2=Moderate straining, 3=Strong straining or 4=Very strong straining with higher scores indicating more severe straining. (NCT02651155)
Timeframe: Weeks 1, 2, 3 and 4

,
Interventionscores on a scale (Mean)
Week 1Week 2Week 3Week 4
Lubiprostone 24 μg1.71.61.41.3
Placebo2.32.01.92.0

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Mean Degree Stool Consistency Score

For each participant, the mean stool consistency score was averaged for all SBMs in a given week. The mean degree of stool consistency for each SBM was collected in the participant diary based on the Bristol Stool Chart. The Bristol Stool Chart is a visual medical aid designed to classify the form of human feces into seven categories where: 1=Hard and round (difficult-to-pass), 2=Sausage-shaped but hard stool, 3=Sausage-shaped stool with cracks on the surface, 4=Sausage-shaped, soft stool with smooth surface, or coiled stool, 5=Soft, half-solid (and easy-to-pass) stool with clear crease, 6=Unshaped, loose stool with small, irregular-shaped pieces, or mushy stool or 7=Watery stool without solid pieces (entirely liquid). (NCT02651155)
Timeframe: Weeks 1, 2, 3 and 4

,
Interventionscores on a scale (Mean)
Week 1Week 2Week 3Week 4
Lubiprostone 24 μg3.63.73.83.8
Placebo3.03.33.23.0

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SBM Frequency at Weeks 2, 3 and 4

A SBM is defined as any BM that does not occur within 24 hours after rescue medication use. SBM frequency data was collected in a diary. Participants were given a diary to complete at home where they recorded the date and time of each BM. (NCT02651155)
Timeframe: Weeks 2, 3 and 4

,
InterventionSBMs/week (Mean)
Week 2Week 3Week 4
Lubiprostone 24 μg5.05.15.2
Placebo3.93.83.7

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Weekly Abdominal Symptoms Score

The abdominal symptoms (bloating and discomfort upon waking in the morning) were scored weekly on a 5-point scale, where: 0=None, 1=Mild, 2=Moderate, 3=Severe or 4=Very severe, with a higher score indicating more severe symptoms. Assessment of weekly abdominal symptoms were recorded by the participant in the diary. (NCT02651155)
Timeframe: Weeks 1, 2, 3 and 4

,
Interventionscores on a sclae (Mean)
Abdominal Bloating, Week 1Abdominal Bloating, Week 2Abdominal Bloating, Week 3Abdominal Bloating, Week 4Abdominal Discomfort, Week 1Abdominal Discomfort, Week 2Abdominal Discomfort, Week 3Abdominal Discomfort, Week 4
Lubiprostone 24 μg1.51.31.21.11.51.31.21.2
Placebo1.61.51.61.41.71.61.61.5

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Weekly Responder Rate

"The responder rate was assessed each week and was derived from the data on SBMs collected in the diary. A non-responder was defined as any participant with a spontaneous BM frequency rate of less than 3 for a given week, any participant who dropped out during or before the given week due to lack of efficacy, or any participant who used rescue medication during or within 24 hours before the given week. Otherwise, the participant subject was considered a responder.~A responder with a spontaneous BM frequency rate ≥3 but <4 was considered a moderate responder. Otherwise, the participant was a full responder (≥4 SBM)." (NCT02695719)
Timeframe: Weeks 1, 2, 3 and 4

,
Interventionpercentage of participants (Number)
Moderate Responders, Week 1Moderate Responders, Week 2Moderate Responders, Week 3Moderate Responders, Week 4Full Responders, Week 1Full Responders, Week 2Full Responders, Week 3Full Responders, Week 4
Lubiprostone 24 μg18.323.224.424.456.158.552.450.0
Placebo27.024.324.320.331.132.437.835.1

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Weekly Abdominal Symptoms Score

The abdominal symptoms (bloating and discomfort upon waking in the morning) were scored weekly on a 5-point scale, where: 0=None, 1=Mild, 2=Moderate, 3=Severe or 4=Very severe, with a higher score indicating more severe symptoms. Assessment of weekly abdominal symptoms were recorded by the participant in the diary. (NCT02695719)
Timeframe: Weeks 1, 2, 3 and 4

,
Interventionscores on a sclae (Mean)
Abdominal Bloating, Week 1Abdominal Bloating, Week 2Abdominal Bloating, Week 3Abdominal Bloating, Week 4Abdominal Discomfort, Week 1Abdominal Discomfort, Week 2Abdominal Discomfort, Week 3Abdominal Discomfort, Week 4
Lubiprostone 24 μg1.71.51.51.41.51.51.41.4
Placebo1.91.81.71.61.91.71.61.5

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SBM Frequency at Weeks 2, 3 and 4

A SBM was defined as any BM that does not occur within 24 hours after rescue medication use. Participants will be given a diary to complete at home where they will record all details of each SBM including the consistency of the stool and the difficulty they have in passing it. (NCT02695719)
Timeframe: Weeks 2, 3 and 4

,
InterventionSBMs/week (Mean)
Week 2Week 3Week 4
Lubiprostone 24 μg4.24.14.0
Placebo3.23.43.2

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Mean Degree Stool Consistency Score

For each participant, the mean stool consistency score was averaged for all SBMs in a given week. The mean degree of stool consistency for each SBM was collected in the participant diary based on the Bristol Stool Chart. The Bristol Stool Chart is a visual medical aid designed to classify the form of human feces into seven categories where: 1=Hard and round (difficult-to-pass), 2=Sausage-shaped but hard stool, 3=Sausage-shaped stool with cracks on the surface, 4=Sausage-shaped, soft stool with smooth surface, or coiled stool, 5=Soft, half-solid (and easy-to-pass) stool with clear crease, 6=Unshaped, loose stool with small, irregular-shaped pieces, or mushy stool or 7=Watery stool without solid pieces (entirely liquid). (NCT02695719)
Timeframe: Weeks 1, 2, 3 and 4

,
Interventionscores on a scale (Mean)
Week 1Week 2Week 3Week 4
Lubiprostone 24 μg4.24.34.14.1
Placebo3.23.33.33.3

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Mean Degree of Straining Score

For each participant, the mean degree of straining was averaged for all SBMs in a given week. The degree of straining for each SBM was collected in the participant diary. The degree of straining is scored on a 5-point scale where: 0=No straining, 1=Mild straining, 2=Moderate straining, 3=Strong straining or 4=Very strong straining with higher scores indicating more severe straining. (NCT02695719)
Timeframe: Weeks 1, 2, 3 and 4

,
Interventionscores on a scale (Mean)
Week 1Week 2Week 3Week 4
Lubiprostone 24 μg2.02.02.01.9
Placebo2.32.22.12.1

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Spontaneous Bowel Movement (SBM) Frequency at Week 1

A SBM was defined as any bowel movement (BM) that does not occur within 24 hours after rescue medication use (laxative, suppository, or enema). Participants will be given a diary to complete at home where they will record all details of each SBM including the consistency of the stool and the difficulty they have in passing it. (NCT02695719)
Timeframe: Week 1

InterventionSBMs/week (Mean)
Placebo3.1
Lubiprostone 24 μg4.4

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Percentage of Participants Who Had a SBM Within 24 Hours After the First Dose of Study Medication

A SBM was defined as any BM that does not occur within 24 hours after rescue medication use. Percentage of participants who have an SBM within 24 hours after the first dose will be assessed and derived from the data on SBMs collected in the participant diary. (NCT02695719)
Timeframe: Up to 24 hours after the first dose of study medication

Interventionpercentage of participants (Number)
Placebo35.1
Lubiprostone 24 μg56.8

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Weekly Abdominal Symptoms Score

Weekly abdominal symptoms of bloating and discomfort upon waking in the morning was scored weekly on a 5-point scale where: 0=None, 1=Mild, 2=Moderate, 3=Severe or 4=Very severe, with a higher score indicating more severe symptoms. Assessment of weekly abdominal symptoms were recorded in the participant in the diary. (NCT02729909)
Timeframe: Weeks 1, 2, 3 and 4

,
Interventionscore on a scale (Mean)
Week 1Week 2Week 3Week 4
Lubiprostone 24 μg1.41.21.00.9
Placebo1.81.51.41.2

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SBM Frequency at Weeks 2, 3 and 4

A SBM is defined as any BM that does not occur within 24 hours after rescue medication use (laxative, suppository, or enema). Participants were given a diary to complete at home where they have recorded all details of each SBM including the consistency of the stool and the difficulty they have in passing it. (NCT02729909)
Timeframe: Weeks 2, 3 and 4

,
Interventionnumber of SBM per week (Mean)
Week 2Week 3Week 4
Lubiprostone 24 μg6.97.67.2
Placebo5.56.05.8

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Mean Degree of Straining Score

For each participant, the mean degree of straining was averaged for all SBMs in a given week. The degree of straining for each SBM was collected in the participant diary. The degree of straining was scored on a 5-point scale where: 0=No straining, 1=Mild straining, 2=Moderate straining, 3=Strong straining or 4=Very strong straining with higher scores indicating more severe straining. (NCT02729909)
Timeframe: Weeks 1, 2, 3 and 4

,
Interventionscore on a scale (Mean)
Week 1Week 2Week 3Week 4
Lubiprostone 24 μg1.61.51.31.2
Placebo2.01.81.61.5

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Mean Degree of Stool Consistency

For each participant, the mean stool consistency score was averaged for all SBMs in a given week. The mean degree of stool consistency for each SBM was collected in the participant diary based on the Bristol Stool Chart. The Bristol Stool Chart is a medical aid designed to classify the form of human feces into seven categories where: 1=Hard and round (difficult-to-pass), 2=Sausage-shaped but hard stool, 3=Sausage-shaped stool with cracks on the surface, 4=Sausage-shaped, soft stool with smooth surface, or coiled stool, 5=Soft, half-solid (and easy-to-pass) stool with clear crease, 6=Unshaped, loose stool with small, irregular-shaped pieces, or mushy stool or 7=Watery stool without solid pieces (entirely liquid). (NCT02729909)
Timeframe: Weeks 1, 2, 3 and 4

,
Interventionscore on a scale (Mean)
Week 1Week 2Week 3Week 4
Lubiprostone 24 μg4.14.14.14.1
Placebo3.43.53.53.6

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Spontaneous Bowel Movement (SBM) Frequency at Week 1 of Administration

A SBM is defined as any bowel movement (BM) that does not occur within 24 hours after rescue medication use (laxative, suppository, or enema). Participants were given a diary to complete at home where they have recorded all details of each SBM including the consistency of the stool and the difficulty they have in passing it. (NCT02729909)
Timeframe: Week 1

Interventionnumber of SBM per week (Mean)
Lubiprostone 24 μg6.7
Placebo5.2

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Percentage of Participants Who Have a SBM Within 24 Hours After First Dose of Study Medication

A SBM is defined as any BM that does not occur within 24 hours after rescue medication use. Percentage of participants who have an SBM within 24 hours after the first dose was assessed and derived from the data on SBMs collected in the participant diary. (NCT02729909)
Timeframe: Up to 24 hours after the first dose of study medication

Interventionpercentage of participants (Number)
Lubiprostone 24 μg60.0
Placebo41.5

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Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)

Adverse events with onset dates after the administration of the first dose of study medication or prior to the last day of treatment plus 7 days are considered treatment-emergent. (NCT02766777)
Timeframe: within 25 weeks

InterventionParticipants (Count of Participants)
Lubiprostone47

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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is any untoward medical occurrence that results in death;is life-threatening;requires inpatient hospitalization or prolongation of present hospitalization;results in persistent or significant disability/incapacity;is a congenital anomaly/birth defect;or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent. (NCT03010631)
Timeframe: From the first dose of study drug up to 28 days

,,,
InterventionParticipants (Count of Participants)
Adverse EventsSerious Adverse Events
Treatment A: Lubiprostone Capsule, Fasted130
Treatment B: Sprinkle Formulation, Fasted230
Treatment C: Sprinkle Formulation, Fed60
Treatment D: Sprinkle Formulation, Fasted60

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Cohort 2: Total Exposure (AUC0-t) of M3 With Administration of Sprinkle Lubiprostone Under Fed Versus (vs) Fasted Condition

(NCT03010631)
Timeframe: 1 day

Interventionh*pg/mL (Geometric Least Squares Mean)
Treatment C: Sprinkle Formulation, Fed135.805
Treatment D: Sprinkle Formulation, Fasted152.900

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Cohort 1: Maximum Observed Concentration (Cmax) of M3 Metabolite

(NCT03010631)
Timeframe: 1 day

Interventionpg/mL (Geometric Mean)
Treatment A: Lubiprostone Capsule, Fasted63.463
Treatment B: Sprinkle Formulation, Fasted127.729

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Cohort 1: Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measurable Concentration (AUC0-t) of M3 Metabolite

(NCT03010631)
Timeframe: 1 day

Interventionh*pg/mL (Geometric Mean)
Treatment A: Lubiprostone Capsule, Fasted117.518
Treatment B: Sprinkle Formulation, Fasted163.615

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Cohort 2: Maximum Observed Concentration (Cmax) of M3 Metabolite in Fed vs Fasted Conditions

(NCT03010631)
Timeframe: 1 day

Interventionpg/mL (Geometric Mean)
Treatment C: Sprinkle Formulation, Fed48.192
Treatment D: Sprinkle Formulation, Fasted116.815

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Mean SBM Consistency Score Within 1 Week

Stool consistency associated with SBMs was rated according to the 7-point Bristol Stool Form Scale (1-7) where 1 = Separate hard lumps, like nuts (hard to pass), 2 = Sausage-shaped but lumpy, 3 = Like a sausage but with cracks on the surface, 4 = Like a sausage or snake, smooth and soft, 5 = Soft blobs with clear-cut edges (passed easily), 6 = Fluffy pieces with ragged edges, a mushy stool, 7 = Watery, no solid pieces; entirely liquid. Scores in the mid-range of this scale indicate better stool consistency. (NCT03097861)
Timeframe: during the 1-week treatment period

,,
Interventionscore on a scale (Mean)
BaselineWeek 1
Lubiprostone Capsule2.284.22
Lubiprostone Sprinkle2.393.94
Placebo2.473.43

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Observed Spontaneous Bowel Movement (SBM) Count Within 1 Week

Observed SBM count was based on the observed data reported in the electronic daily diary for the actual number of SBMs during the 1-week treatment period. (NCT03097861)
Timeframe: during the 1-week treatment period

,,
InterventionSBMs/week (Mean)
BaselineWeek 1
Lubiprostone Capsule1.355.74
Lubiprostone Sprinkle1.374.82
Placebo1.383.68

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Mean SBM Straining Score Within 1 Week

Bowel straining associated with SBMs was rated on a scale of 0-4 where 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Very severe. Higher score indicates more straining, so a worse condition. (NCT03097861)
Timeframe: during the 1-week treatment period

,,
Interventionscore on a scale (Mean)
BaselineWeek 1
Lubiprostone Capsule2.401.19
Lubiprostone Sprinkle2.311.45
Placebo2.391.76

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

An adverse event (AE) is any untoward medical occurrence (including clinically significant changes in laboratory values or other clinical tests) experienced by a participant administered a pharmaceutical product regardless of causal relationship with the treatment. A TEAE is an episode which occur after the administration of the first dose of study medication and within 7 days after final dose. (NCT03097861)
Timeframe: From first dose of study medication to follow-up (up to 15 days)

InterventionParticipants (Count of Participants)
Placebo21
Lubiprostone Sprinkle40
Lubiprostone Capsule73

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