hydroxyindoleacetic acid has been researched along with Diarrhea in 53 studies
(5-hydroxyindol-3-yl)acetic acid : A member of the class of indole-3-acetic acids that is indole-3-acetic acid substituted by a hydroxy group at C-5.
Diarrhea: An increased liquidity or decreased consistency of FECES, such as running stool. Fecal consistency is related to the ratio of water-holding capacity of insoluble solids to total water, rather than the amount of water present. Diarrhea is not hyperdefecation or increased fecal weight.
| Excerpt | Relevance | Reference |
|---|---|---|
| " The purpose of this study was to evaluate the effect of a tryptophan-lowering diet (TRP) on abdominal and mental symptoms in patients with irritable bowel syndrome with predominant diarrhea (IBS-D)." | 8.12 | A Reduced Tryptophan Diet in Patients with Diarrhoea-Predominant Irritable Bowel Syndrome Improves Their Abdominal Symptoms and Their Quality of Life through Reduction of Serotonin Levels and Its Urinary Metabolites. ( Blonska, A; Chojnacki, C; Chojnacki, J; Medrek-Socha, M; Poplawski, T; Zajdel, R, 2022) |
| "To study differences in the visceral sensitivity of the colonic mucosa between patients with diarrhea-predominant irritable bowel syndrome (IBS-D) and those with ulcerative colitis (UC) in remission and to relate these differences with changes in the 5-hydroxytryptophan (5-HT) signaling pathway." | 7.83 | Comparison of 5-hydroxytryptophan signaling pathway characteristics in diarrhea-predominant irritable bowel syndrome and ulcerative colitis. ( Chi, HG; Huang, SG; Lv, RX; Ye, H; Yu, FY; Zhang, HY; Zheng, XB; Zou, Y, 2016) |
| " TELECAST, a phase 3 companion study, assessed the safety and efficacy of telotristat ethyl in patients with CS (diarrhea, flushing, abdominal pain, nausea or elevated urinary 5-hydroxyindoleacetic acid (u5-HIAA)) with <4 BMs/day on SSAs (or ≥1 symptom or ≥4 BMs/day if not on SSAs) during a 12-week double-blind treatment period followed by a 36-week open-label extension (OLE)." | 5.27 | Telotristat ethyl in carcinoid syndrome: safety and efficacy in the TELECAST phase 3 trial. ( Anthony, LB; Benavent, M; Fleming, D; Fleming, R; Garcia-Carbonero, R; Gross, DJ; Hörsch, D; Jiang, W; Kassler-Taub, K; Kulke, MH; Kunz, PL; Lapuerta, P; Pavel, M; Perros, P; Srirajaskanthan, R; Warner, RRP; Wason, S; Weickert, MO, 2018) |
| " The number and intensity of flushing episodes and bowel movements, urinary 5-hydroxyindoleacetic acid (5HIAA) levels, and plasma serotonin levels were recorded." | 5.09 | Treatment of carcinoid syndrome: a prospective crossover evaluation of lanreotide versus octreotide in terms of efficacy, patient acceptability, and tolerance. ( Blumberg, J; Bommelaer, G; Bouché, O; Catus, F; Ducreux, M; O'Toole, D; Ruszniewski, P; Wemeau, JL, 2000) |
| " The purpose of this study was to evaluate the effect of a tryptophan-lowering diet (TRP) on abdominal and mental symptoms in patients with irritable bowel syndrome with predominant diarrhea (IBS-D)." | 4.12 | A Reduced Tryptophan Diet in Patients with Diarrhoea-Predominant Irritable Bowel Syndrome Improves Their Abdominal Symptoms and Their Quality of Life through Reduction of Serotonin Levels and Its Urinary Metabolites. ( Blonska, A; Chojnacki, C; Chojnacki, J; Medrek-Socha, M; Poplawski, T; Zajdel, R, 2022) |
| "The authors conducted a retrospective chart review of patients with carcinoid tumors and elevated serotonin levels (as measured by 24-hour urine 5-hydroxyindoleacetic acid [5-HIAA]) at Dana-Farber/Brigham and Women's Cancer Center who initiated treatment with serotonergic antidepressants after a carcinoid diagnosis from 2003 to 2016." | 3.85 | Retrospective review of serotonergic medication tolerability in patients with neuroendocrine tumors with biochemically proven carcinoid syndrome. ( Brais, LK; Braun, IM; Chan, JA; Dutton, T; Kulke, MH; Meyer, FL; Minden, SL; Shi, DD; Yuppa, DP, 2017) |
| "To study differences in the visceral sensitivity of the colonic mucosa between patients with diarrhea-predominant irritable bowel syndrome (IBS-D) and those with ulcerative colitis (UC) in remission and to relate these differences with changes in the 5-hydroxytryptophan (5-HT) signaling pathway." | 3.83 | Comparison of 5-hydroxytryptophan signaling pathway characteristics in diarrhea-predominant irritable bowel syndrome and ulcerative colitis. ( Chi, HG; Huang, SG; Lv, RX; Ye, H; Yu, FY; Zhang, HY; Zheng, XB; Zou, Y, 2016) |
| " We have studied 73 patients with metastatic carcinoid tumors with regard to stool frequency and plasma concentration of motilin and neuropeptide K (NPK) and diurnal urinary excretion of 5-hydroxyindoleacetic acid (5-HIAA)." | 3.67 | Motilin in plasma and tumor tissues from patients with the carcinoid syndrome. Possible involvement in the increased frequency of bowel movements. ( Norheim, I; Oberg, K; Theodorsson-Norheim, E, 1987) |
| "Flushing was a prominent symptom in 46% and diarrhoea or altered bowel habit in 37%." | 2.39 | The clinical and laboratory correlates of an increased urinary 5-hydroxyindoleacetic acid. ( FitzGerald, RJ; Tormey, WP, 1995) |
| "After one month of treatment, flushing episodes (median (range)) decreased significantly (3 (0." | 1.29 | Treatment of the carcinoid syndrome with the longacting somatostatin analogue lanreotide: a prospective study in 39 patients. ( Bernades, P; Blumberg, J; Chayvialle, JA; Cloarec, D; Ducreux, M; Dupas, JL; Genestin, E; Gouerou, H; Jian, R; Michel, H; Raymond, JM; Rougier, P; Ruszniewski, P, 1996) |
| "A case of pellagra is described that occurred in a patient with an eating disorder and who presented with marked photosensitivity and diarrhoea." | 1.28 | Pellagra in a patient with an eating disorder. ( Judd, LE; Poskitt, BL, 1991) |
| "Thirty patients with symptoms of the carcinoid syndrome and other symptoms not controlled by pharmacological agents were analysed with respect to the value of various treatment measures used." | 1.26 | Use of arterial devascularization and cytotoxic drugs in 30 patients with the carcinoid syndrome. ( Johnson, PJ; Melia, WM; Nunnerley, HB; Williams, R, 1982) |
| "The diagnosis of carcinoid syndrome is made with a good history and confirmed with a 24 hour urine collection for 5 Hydroxy indole acetic acid (5 Hiaa)." | 1.26 | Carcinoid apudoma arising in a glomus jugulare tumor: review of endocrine activity in glomus jugulare tumors. ( Benke, RH; Farrior, JB; Hyams, VJ, 1980) |
| "Treatment with cyproheptadine caused a documented response in the patient's debilitating diarrhoea and also produced symptomatic improvement in her muscular power." | 1.25 | Carcinoid myopathy and treatment with cyproheptadine (Periactin). ( Berry, EM; Maunder, C; Wilson, M, 1974) |
| "Four patients with a malignant carcinoid tumour of the small bowel (three had the carcinoid syndrome) developed gangrene of the small intestine." | 1.25 | Malignant carcinoid tumour with gangrene of the small intestine. ( Marshall, AK; Murray-Lyon, IM; Rake, MO; Williams, R, 1973) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 28 (52.83) | 18.7374 |
| 1990's | 7 (13.21) | 18.2507 |
| 2000's | 10 (18.87) | 29.6817 |
| 2010's | 6 (11.32) | 24.3611 |
| 2020's | 2 (3.77) | 2.80 |
| Authors | Studies |
|---|---|
| Chojnacki, C | 4 |
| Medrek-Socha, M | 2 |
| Blonska, A | 2 |
| Zajdel, R | 2 |
| Chojnacki, J | 4 |
| Poplawski, T | 2 |
| Zandee, WT | 1 |
| Brabander, T | 1 |
| Blažević, A | 1 |
| Minczeles, NS | 1 |
| Feelders, RA | 1 |
| de Herder, WW | 1 |
| Hofland, J | 1 |
| Pavel, M | 2 |
| Gross, DJ | 1 |
| Benavent, M | 1 |
| Perros, P | 1 |
| Srirajaskanthan, R | 1 |
| Warner, RRP | 1 |
| Kulke, MH | 4 |
| Anthony, LB | 2 |
| Kunz, PL | 2 |
| Hörsch, D | 2 |
| Weickert, MO | 1 |
| Lapuerta, P | 3 |
| Jiang, W | 1 |
| Kassler-Taub, K | 1 |
| Wason, S | 1 |
| Fleming, R | 1 |
| Fleming, D | 3 |
| Garcia-Carbonero, R | 1 |
| Błońska, A | 1 |
| Kaczka, A | 1 |
| Stępień, A | 1 |
| Gąsiorowska, A | 1 |
| O'Dorisio, T | 1 |
| Phan, A | 1 |
| Bergsland, E | 2 |
| Law, L | 1 |
| Banks, P | 2 |
| Freiman, J | 1 |
| Frazier, K | 1 |
| Jackson, J | 1 |
| Yao, JC | 1 |
| Kvols, L | 1 |
| Zambrowicz, B | 2 |
| Sands, A | 1 |
| Yu, FY | 1 |
| Huang, SG | 1 |
| Zhang, HY | 1 |
| Ye, H | 1 |
| Chi, HG | 1 |
| Zou, Y | 1 |
| Lv, RX | 1 |
| Zheng, XB | 1 |
| Caplin, ME | 1 |
| Öberg, K | 3 |
| Welin, S | 1 |
| Warner, RR | 1 |
| Lombard-Bohas, C | 1 |
| Grande, E | 1 |
| Valle, JW | 1 |
| Jackson, S | 1 |
| Sands, AT | 1 |
| Shi, DD | 1 |
| Yuppa, DP | 1 |
| Dutton, T | 1 |
| Brais, LK | 1 |
| Minden, SL | 1 |
| Braun, IM | 1 |
| Chan, JA | 1 |
| Meyer, FL | 1 |
| Houghton, LA | 2 |
| Atkinson, W | 2 |
| Whitaker, RP | 1 |
| Whorwell, PJ | 2 |
| Rimmer, MJ | 1 |
| Yazar, A | 1 |
| Büyükafpar, K | 1 |
| Polat, G | 1 |
| Pata, C | 1 |
| Kanýk, A | 1 |
| Tiftik, EN | 1 |
| Bağdatoğlu, O | 1 |
| Lockhart, S | 1 |
| Keevil, B | 1 |
| Kemperman, RF | 1 |
| Muskiet, FD | 1 |
| Boutier, AI | 1 |
| Kema, IP | 1 |
| Muskiet, FA | 1 |
| Moskwa, A | 1 |
| Wiśiewska-Jarosińska, M | 1 |
| Stec-Michalska, K | 1 |
| Szadkowski, K | 1 |
| Smigielski, J | 1 |
| Zuo, XL | 1 |
| Li, YQ | 1 |
| Yang, XZ | 1 |
| Guo, M | 1 |
| Guo, YT | 1 |
| Lu, XF | 1 |
| Li, JM | 1 |
| Desmond, PV | 1 |
| Preshaw, RM | 1 |
| Leavitt, D | 1 |
| Hoag, G | 1 |
| Feldman, JM | 1 |
| Melia, WM | 1 |
| Nunnerley, HB | 1 |
| Johnson, PJ | 1 |
| Williams, R | 2 |
| Quatrini, M | 1 |
| Basilisco, G | 1 |
| Conte, D | 1 |
| Bozzani, A | 1 |
| Bardella, MT | 1 |
| Bianchi, PA | 1 |
| Giannini, AJ | 1 |
| Castellani, S | 1 |
| Dvoredsky, AE | 1 |
| Farrior, JB | 2 |
| Hyams, VJ | 1 |
| Benke, RH | 1 |
| Dharmsathaphorn, K | 1 |
| Sherwin, RS | 1 |
| Cataland, S | 1 |
| Jaffe, B | 1 |
| Dobbins, J | 1 |
| Tormey, WP | 1 |
| FitzGerald, RJ | 1 |
| Saslow, SB | 1 |
| Camilleri, M | 1 |
| Thomforde, GM | 1 |
| Van Dyke, CT | 1 |
| Pitot, HC | 1 |
| Rubin, J | 3 |
| Virally-Monod, ML | 1 |
| Guillausseau, PJ | 1 |
| Assayag, M | 1 |
| Tielmans, D | 1 |
| Ajzenberg, C | 1 |
| Vasseur-Mallus, S | 1 |
| Imberty, C | 1 |
| Warnet, A | 1 |
| Ruszniewski, P | 2 |
| Ducreux, M | 2 |
| Chayvialle, JA | 2 |
| Blumberg, J | 2 |
| Cloarec, D | 1 |
| Michel, H | 1 |
| Raymond, JM | 1 |
| Dupas, JL | 1 |
| Gouerou, H | 1 |
| Jian, R | 1 |
| Genestin, E | 1 |
| Bernades, P | 1 |
| Rougier, P | 1 |
| Bearcroft, CP | 1 |
| Perrett, D | 1 |
| Farthing, MJ | 1 |
| Ajani, J | 1 |
| Schirmer, W | 1 |
| Venook, AP | 1 |
| Bukowski, R | 1 |
| Pommier, R | 1 |
| Saltz, L | 1 |
| Dandona, P | 1 |
| Anthony, L | 1 |
| O'Toole, D | 1 |
| Bommelaer, G | 1 |
| Wemeau, JL | 1 |
| Bouché, O | 1 |
| Catus, F | 1 |
| Helander, A | 1 |
| Some, M | 1 |
| Ricci, S | 1 |
| Antonuzzo, A | 1 |
| Galli, L | 1 |
| Ferdeghini, M | 1 |
| Bodei, L | 1 |
| Orlandini, C | 1 |
| Conte, PF | 1 |
| Judd, LE | 1 |
| Poskitt, BL | 1 |
| Kvols, LK | 1 |
| Moertel, CG | 3 |
| O'Connell, MJ | 1 |
| Schutt, AJ | 1 |
| Hahn, RG | 1 |
| Norheim, I | 2 |
| Theodorsson-Norheim, E | 2 |
| Lindgren, PG | 1 |
| Lundqvist, G | 1 |
| Magnusson, A | 1 |
| Wide, L | 1 |
| Wilander, E | 1 |
| King, MD | 1 |
| Young, DG | 1 |
| Hann, IM | 1 |
| Patrick, WJ | 1 |
| Orr, KB | 1 |
| Berry, EM | 1 |
| Maunder, C | 1 |
| Wilson, M | 1 |
| Gillett, DJ | 1 |
| Smith, RC | 1 |
| von Studnitz, W | 1 |
| Patchefsky, AS | 1 |
| Solit, R | 1 |
| Phillips, LD | 1 |
| Craddock, M | 1 |
| Harrer, MV | 1 |
| Cohn, HE | 1 |
| Kowlessar, OD | 1 |
| Dreux, C | 1 |
| Bousquet, B | 1 |
| Halter, D | 1 |
| Qizilbash, AH | 1 |
| Trebilcock, RG | 1 |
| Patterson, MC | 1 |
| Lamont, KG | 1 |
| Steinfeld, CM | 1 |
| Woolner, LB | 1 |
| Davis, Z | 1 |
| McIlrath, DC | 1 |
| Murray-Lyon, IM | 1 |
| Rake, MO | 1 |
| Marshall, AK | 1 |
| Smith, AG | 1 |
| Greaves, MW | 1 |
| Díaz Recasens, J | 1 |
| Ruíz Palomo, F | 1 |
| Pérez Corral, F | 1 |
| Rapado, A | 1 |
| Grahame-Smith, DG | 1 |
| Satterlee, WG | 1 |
| Serpick, A | 1 |
| Bianchine, JR | 1 |
| Bhana, D | 1 |
| Hillier, K | 1 |
| Karim, SM | 1 |
| Benda, L | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Phase 3, Randomized, Placebo-controlled, Multicenter, Double-blind Study to Evaluate the Safety and Efficacy of Telotristat Etiprate (LX1606) in Patients With Carcinoid Syndrome[NCT02063659] | Phase 3 | 76 participants (Actual) | Interventional | 2014-03-11 | Completed | ||
| A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Ascending, Multidose Study To Determine Safety and Tolerability of Orally Administered LX1606 in Subjects With Symptomatic Carcinoid Syndrome Refractory to Stable-Dose Octreotide Long-A[NCT00853047] | Phase 2 | 23 participants (Actual) | Interventional | 2009-03-31 | Completed | ||
| A Study on the Relationship Between Biodiversity of Intestinal Microbiota in Patients and Different Sedative-hypnotics Undergoing Mechanical Ventilation[NCT03401736] | 0 participants (Actual) | Interventional | 2018-03-01 | Withdrawn (stopped due to Can't get enough participant) | |||
| Safety of Lanreotide 120 mg ATG in Combination With Metformin in Patients With Progressive Advanced Well-differentiated Gastro-intestinal (GI) or Lung Carcinoids: A Pilot, One-arm, Open-label, Prospective Study: the MetNET-2 Trial[NCT02823691] | Early Phase 1 | 20 participants (Actual) | Interventional | 2016-04-30 | Active, not recruiting | ||
| UPCC 04219 Phase 2 Study of Capecitabine-Temozolomide(CapTem) With Yttrium-90 Radioembolization in the Treatment of Patients With Unresectable Metastatic Grade 2 Neuroendocrine Tumors[NCT04339036] | Phase 2 | 50 participants (Anticipated) | Interventional | 2021-10-07 | Recruiting | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
Participants recorded abdominal pain in a daily diary. Participants evaluated the level of any abdominal pain using an 11-point numeric rating scale, where: 0=no pain to 10=worst pain ever experienced. The average daily abdominal pain was averaged over the 12-week period. A negative change from Baseline indicates improvement. (NCT02063659)
Timeframe: Baseline and 12 Weeks
| Intervention | score on a scale (Mean) |
|---|---|
| Placebo | -0.063 |
| 250 mg Telotristat Etiprate | -0.234 |
| 500 mg Telotristat Etiprate | 0.025 |
Participants assessed stool form/consistency of a BM using the Bristol Stool Form Scale where: 1=hard lumps to 7=watery liquid. The daily scores were averaged over the 12-week period. A negative change indicates improvement. (NCT02063659)
Timeframe: Baseline and 12 Weeks
| Intervention | score on a scale (Mean) |
|---|---|
| Placebo | 0.006 |
| 250 mg Telotristat Etiprate | -0.196 |
| 500 mg Telotristat Etiprate | -0.597 |
Participants recorded the number of bowel movements per day in a daily diary. The total number of BMs per day were averaged over the 12-week period. A negative change from Baseline indicates improvement. (NCT02063659)
Timeframe: Baseline and 12 weeks
| Intervention | counts/day (Mean) |
|---|---|
| Placebo | 0.050 |
| 250 mg Telotristat Etiprate | -0.452 |
| 500 mg Telotristat Etiprate | -0.595 |
Participants recorded the number of bowel movements per day in a daily diary. The total number of BMs per day were averaged over the 12-week period. A negative change from Baseline indicates improvement. (NCT02063659)
Timeframe: Baseline and 12 Weeks
| Intervention | counts/day (Mean) |
|---|---|
| 250 mg Telotristat Etiprate | -0.906 |
| 500 mg Telotristat Etiprate | -0.98 |
Participants recorded the number daily flushing episodes per day in a daily diary. The total number of flushing episodes per day were averaged over the 12-week period. A negative change from Baseline indicates improvement. (NCT02063659)
Timeframe: Baseline and 12 Weeks
| Intervention | counts/day (Mean) |
|---|---|
| Placebo | -0.333 |
| 250 mg Telotristat Etiprate | -0.061 |
| 500 mg Telotristat Etiprate | 0.114 |
The frequency (the number of times) the participant used rescue with SSA to control symptoms was recorded in a daily diary. The daily number of rescue treatments with SSA was averaged over the 12- week period. A negative change from Baseline (less use of SSA) indicates improvement. (NCT02063659)
Timeframe: Baseline and 12 weeks
| Intervention | counts/day (Mean) |
|---|---|
| Placebo | -0.013 |
| 250 mg Telotristat Etiprate | -0.065 |
| 500 mg Telotristat Etiprate | 0.006 |
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1. (NCT02063659)
Timeframe: First dose of study drug to within 30 days of last dose of study drug in the Double-Blind Treatment Period (Up to 17.1 Weeks)
| Intervention | Participants (Count of Participants) |
|---|---|
| Placebo | 21 |
| 250 mg Telotristat Etiprate | 25 |
| 500 mg Telotristat Etiprate | 22 |
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1. (NCT02063659)
Timeframe: First dose of study drug to within 30 days of last dose of study drug in the Open-Label Extension Period (Up to 52.6 Weeks)
| Intervention | Participants (Count of Participants) |
|---|---|
| Telotristat Etiprate Open-Label Extension | 61 |
u5-HIAA is a standard test used in clinical practice to assess neuroendocrine tumor (NET) activity and is collected as a 24-hour urine specimen. A negative change from Baseline indicates improvement. (NCT02063659)
Timeframe: Baseline and 12 Weeks
| Intervention | percentage change of mg/24 hours (Mean) |
|---|---|
| Placebo | 97.721 |
| 250 mg Telotristat Etiprate | -33.164 |
| 500 mg Telotristat Etiprate | -76.466 |
Blood samples were collected for assessment of Chromogranin A level. A negative change from Baseline indicates improvement. (NCT00853047)
Timeframe: Baseline to Week 4
| Intervention | ng/mL (Mean) |
|---|---|
| Placebo Core Phase | -3251.2 |
| Telotristat Etiprate 150 mg Core Phase | -190.5 |
| Telotristat Etiprate 250 mg Core Phase | -12.3 |
| Telotristat Etiprate 350 mg Core Phase | 52.5 |
| Telotristat Etiprate 500 mg Core Phase | 26011.4 |
Participants recorded details (location and frequency of injection) of subcutaneous injections of rescue, short-acting octreotide, if taken, in the daily diary. A negative change from Baseline indicates improvement. (NCT00853047)
Timeframe: Baseline to Week 4
| Intervention | injections per day (Mean) |
|---|---|
| Placebo Core Phase | -0.38 |
| Telotristat Etiprate 150 mg Core Phase | -0.03 |
| Telotristat Etiprate 250 mg Core Phase | 0.03 |
| Telotristat Etiprate 350 mg Core Phase | 0.00 |
| Telotristat Etiprate 500 mg Core Phase | -0.29 |
Participants recorded the number of BMs per day in a daily diary. The total number of BMs per day were averaged over the 4-week period. A negative change from Baseline indicates improvement. (NCT00853047)
Timeframe: Baseline to Week 4
| Intervention | bowel movements/day (Mean) |
|---|---|
| Placebo Core Phase | 0.82 |
| Telotristat Etiprate 150 mg Core Phase | -1.37 |
| Telotristat Etiprate 250 mg Core Phase | -2.17 |
| Telotristat Etiprate 350 mg Core Phase | -0.20 |
| Telotristat Etiprate 500 mg Core Phase | -0.71 |
Participants recorded the number of daily flushing episodes per day in a daily diary. The total number of flushing episodes per day were averaged over the 4-week period. A negative change from Baseline indicates improvement. (NCT00853047)
Timeframe: Baseline to Week 4
| Intervention | cutaneous flushing episodes (Mean) |
|---|---|
| Placebo Core Phase | -0.43 |
| Telotristat Etiprate 150 mg Core Phase | -0.60 |
| Telotristat Etiprate 250 mg Core Phase | -0.30 |
| Telotristat Etiprate 350 mg Core Phase | -0.10 |
| Telotristat Etiprate 500 mg Core Phase | -0.03 |
Participants recorded the sensation of urgency to defecate (Yes or No) in a daily diary. A negative change from Baseline indicates improvement. (NCT00853047)
Timeframe: Baseline to Week 4
| Intervention | percentage of days (Mean) |
|---|---|
| Placebo Core Phase | -2.72 |
| Telotristat Etiprate 150 mg Core Phase | -34.43 |
| Telotristat Etiprate 250 mg Core Phase | -32.13 |
| Telotristat Etiprate 350 mg Core Phase | 0.00 |
| Telotristat Etiprate 500 mg Core Phase | -8.49 |
Participants recorded the severity of abdominal pain or discomfort in a daily diary assessed using a 4-point scale (0-none, 1-mild, 2-moderate, 3-severe). A negative change from Baseline indicates improvement. (NCT00853047)
Timeframe: Baseline to Week 4
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo Core Phase | 0.04 |
| Telotristat Etiprate 150 mg Core Phase | 0.03 |
| Telotristat Etiprate 250 mg Core Phase | -0.53 |
| Telotristat Etiprate 350 mg Core Phase | 0.03 |
| Telotristat Etiprate 500 mg Core Phase | 0.16 |
u5-HIAA is a standard test used in clinical practice to assess the neuroendocrine tumor (NET) activity and is collected as a 24-hour urine specimen. A negative change from Baseline indicates improvement. (NCT00853047)
Timeframe: Baseline to Week 4
| Intervention | mg/24 hours (Mean) |
|---|---|
| Placebo Core Phase | -20.73 |
| Telotristat Etiprate 150 mg Core Phase | -27.55 |
| Telotristat Etiprate 250 mg Core Phase | -0.67 |
| Telotristat Etiprate 350 mg Core Phase | 13.60 |
| Telotristat Etiprate 500 mg Core Phase | -35.49 |
Participants recorded stool form in a daily diary using a 6-point scale (0-none,1-hard, 2-firm, 3-soft, 4-loose, 5-watery). A negative change from Baseline indicates improvement. (NCT00853047)
Timeframe: Baseline to Week 4
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo Core Phase | -0.07 |
| Telotristat Etiprate 150 mg Core Phase | -0.50 |
| Telotristat Etiprate 250 mg Core Phase | 0.00 |
| Telotristat Etiprate 350 mg Core Phase | 0.00 |
| Telotristat Etiprate 500 mg Core Phase | -0.17 |
"Complete Response to treatment was defined as one of the following: 1. Less than 4 bowel movements per day; or 2. A decrease in daily bowel movements that is ≥ 50% from baseline; or 3. A positive response to the global assessment question (In the past 7 days, have you had adequate relief of your carcinoid syndrome bowel complaints such as diarrhea, urgent need to have a bowel movement, abdominal pain or discomfort?) for each of the last 2 weeks of the Treatment Period." (NCT00853047)
Timeframe: Baseline to Week 4
| Intervention | Participants (Count of Participants) |
|---|---|
| Placebo Core Phase | 0 |
| Telotristat Etiprate 150 mg Core Phase | 1 |
| Telotristat Etiprate 250 mg Core Phase | 2 |
| Telotristat Etiprate 350 mg Core Phase | 1 |
| Telotristat Etiprate 500 mg Core Phase | 2 |
"Participants were asked to answer the following question: In the past 7 days, have you had adequate relief of your carcinoid syndrome bowel complaints such as diarrhea, urgent need to have a bowel movement, abdominal pain, or discomfort?. The number of participants who answered Yes are reported." (NCT00853047)
Timeframe: Week 4
| Intervention | Participants (Count of Participants) |
|---|---|
| Placebo Core Phase | 0 |
| Telotristat Etiprate 150 mg Core Phase | 1 |
| Telotristat Etiprate 250 mg Core Phase | 2 |
| Telotristat Etiprate 350 mg Core Phase | 1 |
| Telotristat Etiprate 500 mg Core Phase | 3 |
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after receiving treatment. (NCT00853047)
Timeframe: Up to 180 weeks in the open-label extension phase
| Intervention | Participants (Count of Participants) |
|---|---|
| Telotristat Etiprate Open-Label Extension Phase | 18 |
Time to the first subcutaneous injections of rescue, short-acting octreotide was determined from the participant's daily diary. (NCT00853047)
Timeframe: Baseline to Week 4
| Intervention | days (Median) |
|---|---|
| Placebo Core Phase | 1.00 |
| Telotristat Etiprate 500 mg Core Phase | 1.00 |
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1. (NCT00853047)
Timeframe: Up to 4 Weeks Core Phase
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Any TEAE | Related TEAEs | |
| Placebo Core Phase | 4 | 3 |
| Telotristat Etiprate 150 mg Core Phase | 3 | 3 |
| Telotristat Etiprate 250 mg Core Phase | 3 | 0 |
| Telotristat Etiprate 350 mg Core Phase | 2 | 2 |
| Telotristat Etiprate 500 mg Core Phase | 9 | 6 |
3 reviews available for hydroxyindoleacetic acid and Diarrhea
| Article | Year |
|---|---|
The clinical and laboratory correlates of an increased urinary 5-hydroxyindoleacetic acid.
Topics: Adolescent; Adrenal Gland Neoplasms; Adult; Aged; Aged, 80 and over; Carcinoid Tumor; Diagnostic Ima | 1995 |
Functioning primary carcinoid tumor of the ovary. A light- and electron-microscopic study with review of the literature.
Topics: Aged; Ankle; Appendix; Carcinoid Tumor; Diarrhea; Edema; Female; Hepatomegaly; Humans; Hydroxyindole | 1974 |
Progress report: the carcinoid syndrome.
Topics: 5-Hydroxytryptophan; Antineoplastic Agents; Bradykinin; Diarrhea; Heart Valve Diseases; Humans; Hydr | 1970 |
6 trials available for hydroxyindoleacetic acid and Diarrhea
| Article | Year |
|---|---|
Telotristat ethyl in carcinoid syndrome: safety and efficacy in the TELECAST phase 3 trial.
Topics: Adult; Aged; Aged, 80 and over; Diarrhea; Double-Blind Method; Female; Humans; Hydroxyindoleacetic A | 2018 |
Telotristat etiprate, a novel serotonin synthesis inhibitor, in patients with carcinoid syndrome and diarrhea not adequately controlled by octreotide.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents, Hormonal; Diarrhea; Female; Gastrointestinal | 2014 |
Telotristat Ethyl, a Tryptophan Hydroxylase Inhibitor for the Treatment of Carcinoid Syndrome.
Topics: Aged; Antineoplastic Agents, Hormonal; Defecation; Diarrhea; Double-Blind Method; Female; gamma-Glut | 2017 |
Octreotide acetate long-acting formulation versus open-label subcutaneous octreotide acetate in malignant carcinoid syndrome.
Topics: Carcinoid Tumor; Delayed-Action Preparations; Diarrhea; Dose-Response Relationship, Drug; Double-Bli | 1999 |
Treatment of carcinoid syndrome: a prospective crossover evaluation of lanreotide versus octreotide in terms of efficacy, patient acceptability, and tolerance.
Topics: Antineoplastic Agents; Biomarkers, Tumor; Carcinoid Tumor; Cross-Over Studies; Diarrhea; Female; Flu | 2000 |
Octreotide acetate long-acting release in patients with metastatic neuroendocrine tumors pretreated with lanreotide.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents, Hormonal; Biomarkers, Tumor; Carcinoid Tumor; | 2000 |
44 other studies available for hydroxyindoleacetic acid and Diarrhea
| Article | Year |
|---|---|
A Reduced Tryptophan Diet in Patients with Diarrhoea-Predominant Irritable Bowel Syndrome Improves Their Abdominal Symptoms and Their Quality of Life through Reduction of Serotonin Levels and Its Urinary Metabolites.
Topics: Diarrhea; Diet; Humans; Hydroxyindoleacetic Acid; Irritable Bowel Syndrome; Quality of Life; Seroton | 2022 |
A Reduced Tryptophan Diet in Patients with Diarrhoea-Predominant Irritable Bowel Syndrome Improves Their Abdominal Symptoms and Their Quality of Life through Reduction of Serotonin Levels and Its Urinary Metabolites.
Topics: Diarrhea; Diet; Humans; Hydroxyindoleacetic Acid; Irritable Bowel Syndrome; Quality of Life; Seroton | 2022 |
A Reduced Tryptophan Diet in Patients with Diarrhoea-Predominant Irritable Bowel Syndrome Improves Their Abdominal Symptoms and Their Quality of Life through Reduction of Serotonin Levels and Its Urinary Metabolites.
Topics: Diarrhea; Diet; Humans; Hydroxyindoleacetic Acid; Irritable Bowel Syndrome; Quality of Life; Seroton | 2022 |
A Reduced Tryptophan Diet in Patients with Diarrhoea-Predominant Irritable Bowel Syndrome Improves Their Abdominal Symptoms and Their Quality of Life through Reduction of Serotonin Levels and Its Urinary Metabolites.
Topics: Diarrhea; Diet; Humans; Hydroxyindoleacetic Acid; Irritable Bowel Syndrome; Quality of Life; Seroton | 2022 |
Peptide Receptor Radionuclide Therapy With 177Lu-DOTATATE for Symptomatic Control of Refractory Carcinoid Syndrome.
Topics: Aged; Aged, 80 and over; Cohort Studies; Diarrhea; Drug Resistance, Neoplasm; Female; Humans; Hydrox | 2021 |
Evaluation of serotonin and dopamine secretion and metabolism in patients with irritable bowel syndrome.
Topics: Adult; Case-Control Studies; Constipation; Diarrhea; Dopamine; Female; Humans; Hydroxyindoleacetic A | 2018 |
Comparison of 5-hydroxytryptophan signaling pathway characteristics in diarrhea-predominant irritable bowel syndrome and ulcerative colitis.
Topics: 5-Hydroxytryptophan; Abdominal Pain; Adult; Colitis, Ulcerative; Colon; Defecation; Diarrhea; Female | 2016 |
Retrospective review of serotonergic medication tolerability in patients with neuroendocrine tumors with biochemically proven carcinoid syndrome.
Topics: Anxiety; Carcinoid Tumor; Depression; Diarrhea; Female; Flushing; Humans; Hydroxyindoleacetic Acid; | 2017 |
Increased platelet depleted plasma 5-hydroxytryptamine concentration following meal ingestion in symptomatic female subjects with diarrhoea predominant irritable bowel syndrome.
Topics: Adult; Blood Platelets; Colonic Diseases, Functional; Diarrhea; Enzyme-Linked Immunosorbent Assay; F | 2003 |
The urinary 5-hydroxyindole acetic acid and plasma nitric oxide levels in irritable bowel syndrome: a preliminary study.
Topics: Adult; Analysis of Variance; Chi-Square Distribution; Constipation; Diarrhea; Female; Humans; Hydrox | 2005 |
Altered 5-hydroxytryptamine signaling in patients with constipation- and diarrhea-predominant irritable bowel syndrome.
Topics: Adult; Case-Control Studies; Chromatography, High Pressure Liquid; Constipation; Diarrhea; Fasting; | 2006 |
Brief report: normal intestinal permeability at elevated platelet serotonin levels in a subgroup of children with pervasive developmental disorders in Curaçao (The Netherlands antilles).
Topics: Blood Platelets; Child; Child Development Disorders, Pervasive; Diarrhea; Female; Humans; Hydroxyind | 2008 |
[Serum serotonin concentration and urine 5-hydroxyindole acetic acid excretion in patients with irritable bowel syndrome].
Topics: Adult; Constipation; Diarrhea; Down-Regulation; Fasting; Female; Humans; Hydroxyindoleacetic Acid; I | 2007 |
Plasma and gastric mucosal 5-hydroxytryptamine concentrations following cold water intake in patients with diarrhea-predominant irritable bowel syndrome.
Topics: Adult; Area Under Curve; Blood Platelets; Cold Temperature; Diarrhea; Drinking; Fasting; Female; Gas | 2007 |
The dietary supplement 5-hydroxytryptophan and urinary 5-hydroxyindole acetic acid.
Topics: 5-Hydroxytryptophan; Antidepressive Agents, Second-Generation; Diarrhea; Female; Humans; Hydroxyindo | 2008 |
Metabolic acidosis in patients with the carcinoid syndrome: treatment with parachlorophenylalanine.
Topics: Acidosis; Diarrhea; Female; Fenclonine; Humans; Hydroxyindoleacetic Acid; Male; Malignant Carcinoid | 1982 |
Use of arterial devascularization and cytotoxic drugs in 30 patients with the carcinoid syndrome.
Topics: Adult; Aged; Carcinoid Tumor; Cyclophosphamide; Diarrhea; Doxorubicin; Embolization, Therapeutic; Fe | 1982 |
Effects of somatostatin infusion in four patients with malignant carcinoid syndrome.
Topics: Aged; Diarrhea; Female; Gastrins; Humans; Hydroxyindoleacetic Acid; Insulin; Male; Malignant Carcino | 1983 |
Anxiety states: relationship to atmospheric cations and serotonin.
Topics: Adult; Air Ionization; Anxiety Disorders; Cations; Diarrhea; Headache; Humans; Hydroxyindoleacetic A | 1983 |
Carcinoid apudoma arising in a glomus jugulare tumor: review of endocrine activity in glomus jugulare tumors.
Topics: Adolescent; Adult; Apudoma; Carcinoid Tumor; Diarrhea; Ear Neoplasms; Female; Glomus Jugulare Tumor; | 1980 |
Somatostatin inhibits diarrhea in the carcinoid syndrome.
Topics: Carcinoid Tumor; Creatinine; Diarrhea; Fasting; Feces; Female; Humans; Hydroxyindoleacetic Acid; Mal | 1980 |
Relation between fat malabsorption and transit abnormalities in human carcinoid diarrhea.
Topics: Aged; Aged, 80 and over; Celiac Disease; Colon; Diarrhea; Dietary Fats; Female; Gastric Emptying; Ga | 1996 |
Variable efficacy of octreotide in diabetic diarrhea.
Topics: Adult; Blood Pressure; Diabetes Mellitus, Type 2; Diarrhea; Heart Rate; Hormones; Humans; Hydroxyind | 1996 |
Treatment of the carcinoid syndrome with the longacting somatostatin analogue lanreotide: a prospective study in 39 patients.
Topics: Biomarkers, Tumor; Diarrhea; Female; Flushing; Humans; Hydroxyindoleacetic Acid; Male; Malignant Car | 1996 |
Postprandial plasma 5-hydroxytryptamine in diarrhoea predominant irritable bowel syndrome: a pilot study.
Topics: Adolescent; Adult; Area Under Curve; Chromatography, High Pressure Liquid; Colonic Diseases, Functio | 1998 |
Dietary serotonin and alcohol combined may provoke adverse physiological symptoms due to 5-hydroxytryptophol.
Topics: Adult; Alcohol Drinking; Diarrhea; Diet; Drug Synergism; Ethanol; Fatigue; Female; Headache; Humans; | 2000 |
Pellagra in a patient with an eating disorder.
Topics: Adult; Anorexia Nervosa; Diarrhea; Female; Humans; Hydroxyindoleacetic Acid; Pellagra; Photosensitiv | 1991 |
Treatment of the malignant carcinoid syndrome. Evaluation of a long-acting somatostatin analogue.
Topics: Adult; Aged; Antineoplastic Agents; Diarrhea; Female; Flushing; Humans; Hydroxyindoleacetic Acid; In | 1986 |
Malignant carcinoid tumors. An analysis of 103 patients with regard to tumor localization, hormone production, and survival.
Topics: Adult; Aged; Bronchial Neoplasms; Diarrhea; Female; Flushing; Gastrointestinal Neoplasms; Heart Arre | 1987 |
Motilin in plasma and tumor tissues from patients with the carcinoid syndrome. Possible involvement in the increased frequency of bowel movements.
Topics: Carcinoid Tumor; Chromatography, High Pressure Liquid; Diarrhea; Female; Gastrointestinal Motility; | 1987 |
[A prolonged-action somatostatin analog and carcinoid syndrome].
Topics: Adult; Aged; Aged, 80 and over; Delayed-Action Preparations; Diarrhea; Female; Flushing; Humans; Hyd | 1989 |
Carcinoid syndrome: an unusual cause of diarrhoea.
Topics: Antineoplastic Combined Chemotherapy Protocols; Child; Diarrhea; Female; Humans; Hydroxyindoleacetic | 1985 |
The carcinoid syndrome: An example due to an ileal polyp.
Topics: Autopsy; Carcinoid Tumor; Cyanosis; Cyproheptadine; Diarrhea; Female; Humans; Hydroxyindoleacetic Ac | 1970 |
Carcinoid myopathy and treatment with cyproheptadine (Periactin).
Topics: Acid Phosphatase; Cyproheptadine; Diarrhea; Feces; Female; Fenclonine; Humans; Hydroxyindoleacetic A | 1974 |
Treatment of the carcinoid syndrome by hemihepatectomy and radical excision of the primary lesion.
Topics: Aged; Cyproheptadine; Diarrhea; Fenclonine; Heart Valve Diseases; Hepatectomy; Humans; Hydroxyindole | 1974 |
[Proceedings: Tryptophan hydroxylase inhibition as therapy for carcinoid tumors].
Topics: Carcinoid Heart Disease; Carcinoid Tumor; Constipation; Diarrhea; Eosinophilia; Fenclonine; Humans; | 1972 |
Serotonin now: clinical implications of inhibiting its synthesis with para-chlorophenylalanine.
Topics: Adult; Aged; Animals; Behavior; Brain Chemistry; Catechols; Cattle; Depression; Diarrhea; Dogs; Enzy | 1970 |
Hydroxyindole-producing tumors of the pancreas. Carcinoid-islet cell tumor and oat cell carcinoma.
Topics: Adenoma, Islet Cell; Angiography; Biopsy; Carcinoma, Bronchogenic; Carcinoma, Small Cell; Cyanosis; | 1972 |
[Detection and biochemical exploration of carcinoid tumors].
Topics: 5-Hydroxytryptophan; Carcinoid Tumor; Chromatography, Ion Exchange; Diarrhea; Heart Diseases; Humans | 1974 |
Diarrhea and medullary carcinoma of the thyroid.
Topics: Aged; Carcinoma; Celiac Disease; Diarrhea; Humans; Hydroxyindoleacetic Acid; Male; Neoplasm Metastas | 1973 |
The malignant carcinoid syndrome.
Topics: Adult; Aged; Appendiceal Neoplasms; Diarrhea; Erythema; Female; Humans; Hydroxyindoleacetic Acid; In | 1973 |
Malignant carcinoid tumour with gangrene of the small intestine.
Topics: Adult; Aged; Biopsy; Carcinoid Tumor; Diarrhea; Female; Gangrene; Humans; Hydroxyindoleacetic Acid; | 1973 |
Blood prostaglandin activity associated with noradrenaline-provoked flush in the carcinoid syndrome.
Topics: Aged; Alkaline Phosphatase; Blister; Body Weight; Carcinoid Tumor; Chromatography, Thin Layer; Diarr | 1974 |
[Carcinoid syndrome. II. Clinical manifestations, diagnosis, prognosis and treatment].
Topics: Antineoplastic Agents; Diarrhea; Epinephrine; Heart Valve Diseases; Humans; Hydroxyindoleacetic Acid | 1974 |
The carcinoid syndrome: chronic treatment with para-chlorophenylalanine.
Topics: Amino Acids; Chlorine; Diarrhea; Dopamine; Heart Valve Diseases; Hepatomegaly; Humans; Hydroxyindole | 1970 |
Vasoactive substances in Kaposi's sarcoma.
Topics: Animals; Arm; Chromatography, Thin Layer; Diarrhea; Guinea Pigs; Histamine; Humans; Hydroxyindoleace | 1971 |
[A neural-endocrine enteropathy].
Topics: Appendiceal Neoplasms; Biopsy; Carcinoid Tumor; Chronic Disease; Diarrhea; Endocrine System Diseases | 1967 |