Phase 3 N=156 Lubiprostone for Treatment of Chronic Idiopathic Constipation
Chronic Idiopathic Constipation
Primary: Spontaneous Bowel Movement (SBM) Frequency at Week 1 — 3.1; 4.4 SBMs/week — p=0.007
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=411 Safety and Tolerability Extension Trial for Patients With Chronic Idiopathic Constipation
Chronic Idiopathic Constipation
Primary: Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 241; 14 Patients
Phase 3 N=951 The Plecanatide Chronic Idiopathic Constipation (CIC) Study
Chronic Idiopathic Constipation
Primary: Overall Responder 9/12 Weeks — 18.6; 16.8; 19.0; 10.7 % of Overall Responder 9/12 weeks
Phase 3 N=204 Lubiprostone for the Treatment of Chronic Idiopathic Constipation
Constipation
Primary: Spontaneous Bowel Movement (SBM) Frequency at Week 1 — 3.6; 5.0 SBMs/week — p=0.003
Phase 3 N=211 Lubiprostone for Chronic Idiopathic Constipation Treatment
Constipation
Primary: Spontaneous Bowel Movement (SBM) Frequency at Week 1 of Administration — 6.7; 5.2 number of SBM per week — p=0.020
N/A N=40 The Effect of CSP01 on Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation
Constipation · Chronic Idiopathic Constipation · Irritable Bowel Syndrome With Constipation
Primary: Change From Baseline in Colonic Transit Time (CTT) — -727; -15; 366 minutes
Phase 3 N=1,223 Trial of Linaclotide in Patients With Chronic Idiopathic Constipation
Chronic Idiopathic Constipation
Primary: Percentage of 12-Week CSBM Overall Responders — 4.7; 13.4; 95.3; 86.6 percentage of participants — p=< 0.0001
Phase 2 N=190 Study of Elobixibat (A3309) in Patients With Chronic Idiopathic Constipation
Constipation · Chronic Constipation
Primary: Change From Baseline in Frequency of Spontaneous Bowel Movements — 2.5; 4.0; 5.4; 1.7 Number of SBMs — p=<0.2
Phase 3 N=2,370 Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)
Chronic Idiopathic Constipation
Primary: Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) — 123; 620 Participants
Phase 3 N=1,337 12-Week Study of Plecanatide for CIC (The National CIC3 Study)
Chronic Idiopathic Constipation
Primary: Number of Durable Overall CSBM Responders, Mean Replacement Approach — 57; 88; 88 Participants
Phase 3 N=1,346 12-Week Study of Plecanatide for CIC (The CIC3 Study)
Chronic Idiopathic Constipation
Primary: Number of Durable Overall CSBM Responders , Mean Replacement Approach — 46; 95; 86 Participants
Phase 3 N=164 Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation
Chronic Idiopathic Constipation
Primary: Number of Spontaneous Bowel Movements (SBMs) Within 1 Week — 4.6; 4.0 number of SBMs — p=0.1290
Phase 4 N=19 Effects of Lubiprostone on Gastric Function in Patients With Chronic Idiopathic Constipation
Chronic Idiopathic Constipation
Primary: Gastric Emptying — 0.27; 0.384; 0.04; 0.051 percent meal retention — p=0.003
Phase 3 N=633 Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation
Chronic Constipation
Primary: Complete Spontaneous Bowel Movement (CSBM) Overall Responder — 13; 34; 43; 202 participants — p=0.0012
Phase 2 N=84 SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation
Chronic Idiopathic Constipation
Primary: Number of Participants With Adverse Events — 3; 6; 2; 6 Participants
Phase 3 N=643 Trial of Linaclotide in Patients With Chronic Constipation
Chronic Constipation
Primary: Complete Spontaneous Bowel Movement (CSBM) Overall Responder — 46; 42; 7 participants — p=<0.0001
Phase 4 N=364 Evaluation of Long-term Prucalopride Treatment With Chronic Constipation in Subjects Aged ≥ 18 Years
Constipation
Primary: The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week Over the 24 Week Treatment Period — 20.7; 25.1 percentage of…
Phase 3 N=1,725 An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
Irritable Bowel Syndrome With Constipation · Chronic Constipation
Primary: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) — 65; 389; 454 Participants
Phase 3 N=1,554 An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
Chronic Constipation · Irritable Bowel Syndrome With Constipation
Primary: Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) — 399; 748 Participants
Phase 2 N=124 An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation
Chronic Idiopathic Constipation
Primary: Proportion of Overall Responders — 7; 10; 12; 7 Participants
N/A N=349 Efficacy and Safety of Vibrant Capsule vs. Placebo for the Treatment of Chronic Idiopathic Constipation
Chronic Idiopathic Constipation
Primary: CSBM1 & CSBM2 Success Rate — 64; 33; 37; 17 Participants — p=0.0011
Phase 3 N=40 Lubiprostone and Mucus Secretion in Patients With Chronic Constipation
Constipation
Primary: Change of Mucus and Mucin Secretion in Patients With Chronic Constipation and in Controls. — 260; 133; 229; 161 mg/hour
Phase 2 N=36 Effect of Ileal Bile Acid Transporter Inhibitor in Functional Constipation
Functional Constipation
Primary: Colonic Transit at 24 Hours — 2.68; 3.12; 1.93 units on a scale — p=0.059
Phase 3 N=434 A Safety and Efficacy Evaluation of BLI801 Laxative in Adults Experiencing Non-Idiopathic Constipation
Constipation
Primary: % of Subjects With Treatment Response — 42; 34; 30; 20 Participants — p=0.034
Phase 4 N=59 Efficacy and Safety of Vibrant Capsule vs. Vibrant Placebo for the Treatment of Chronic Idiopathic Constipation (CIC)
Chronic Idiopathic Constipation
Primary: CSBM1 Success Rate — 9; 8 Participants
Phase 4 N=13 Study to Investigate Prucalopride vs. Polyethylene Glycol 3350 on Colon Activity
Chronic Constipation
Primary: The Number of High-Amplitude Propagating Contractions (HAPC) — 8.7; 2.9 Number of HAPC with amplitude ≥100mmHg — p=0.012
Phase 2 N=36 Cheno Effect on Transit in Health and IBS-C
Constipation-predominant Irritable Bowel Syndrome
Primary: Colonic Geometric Center at 24 Hours (GC24) — 3.1; 3.5; 2.2 units on a scale
Phase 2 N=428 The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)
Irritable Bowel Syndrome Characterized by Constipation
Primary: Change From Baseline in Weekly CSBMs Frequency Over the 12-Week Treatment Period (mITT Population) — 1.28; 2.12; 2.74; 2.44 CSBMs per week
N/A N=52 Effects of Lubiprostone on Gastrointestinal Transit & pH in Irritable Bowel Syndrome (IBS) With Constipation
Irritable Bowel Syndrome · Constipation
Primary: Change in Gastric Emptying Time, Small Bowel Transit Time, Colon Transit Time and Whole Gut Transit Time From Baseline — 5.49; 6.52; -0.16; 0.2 hours
Phase 3 N=487 Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating
Chronic Constipation · Constipation
Primary: 9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder — 13; 24; 158; 129 participants — p=0.0264