Phase 2 N=97 A Dose Determination Study of Chinese Herbal Medicine for Functional Constipation
Constipation
Primary: Responder for Complete Spontaneous Bowel Movement (CSBM) — 10; 14; 17; 22 participants — p=<0.05
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Phase 2 N=120 An Effectiveness and Safety Study of Chinese Herbal Medicine for Functional Constipation
Functional Gastrointestinal Disorders · Constipation
Primary: Responder of Complete Spontaneous Bowel Movement (CSBM) — 26; 5; 34; 55 participants — p=<0.05
Phase 3 N=123 A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation
Functional Constipation (FC) · Chronic Idiopathic Constipation (CIC)
Primary: Change From Baseline in 12-week Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) Observed by the Primary Caregiver During the Double-blind Study Intervention…
Phase 2 N=19 A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Who Are Treated With Linaclotide
Functional Constipation
Primary: Change From Baseline in Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Study Intervention Period — 3.181; 2.503; 0.246; 3.371 SBMs/Week
Phase 3 N=224 B. Lactis HN019 for Functional Constipation
Constipation
Primary: Whole Gut Transit Time
N/A N=27 Effects of Exercise Training on Pelvic Floor Symptoms and Function in Adults With Constipation
Constipation
Primary: Severity of Constipation Symptoms — 0.96; 0.97; 0.63; 0.67 score on a scale
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 2 N=173 A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 6-17 Years Who Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation (FC)
Functional Constipation in Children Ages 6-17 Years
Primary: Change From Baseline (CFB) in 4-week Overall Spontaneous Bowel Movement (SBM) Frequency Rate During the Treatment Period — 2.000; 1.412; 1.814; 2.364 SBMs/week — p=0.3097
N/A N=72 Physiotherapeutic Intervention in Children With Chronic Functional Constipation
Chronic Constipation
Primary: Frequency of Defecation. — 3.9; 5.1 days/week — p=<0.05
N/A N=94 Lcr35 for Children With Functional Constipation
Constipation
Primary: Number of Participants With Treatment Success (≥3 Spontaneous Defecations Per Week With no Fecal Soiling — 24; 28 Participants — p=0.399
Phase 3 N=606 Lubiprostone in Children With Functional Constipation
Constipation - Functional
Primary: Number of Participants Classified as Overall Responders at Week 12 — 76; 28 Participants — p=0.1609
Phase 4 N=153 The Effect of Probiotics on Constipation, and Intestinal Microflora in Children With Functional Constipation
Functional Constipation
Primary: Change of Clostridium Butyricum Miyairi Expression After Probiotics Supplementation in Constipated Children. — 0.00486; 0.0000148; 0.00000189 number of bacteria per mg…
Phase 3 N=215 Prucalopride in Pediatric Subjects With Functional Constipation
Functional Constipation
Primary: Percent of Responders in the Last Four Weeks of the Double-Blind Treatment Period — 17.0; 17.8 percentage of subjects — p=0.9002
Phase 2 N=192 Dose-ranging Efficacy of Polydextrose Supplement on Colonic Transit Time and Symptoms in Adults With Functional Constipation
Functional Constipation
Primary: Change in Colonic Transit Time From Baseline to Day 15 — -1.7; 4.0; 2.5; 2.6 Hours
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
N/A N=120 Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence
Fecal Incontinence
Primary: Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Episodes Per Week — 0.73 proportion of subjects — p=<0.0001
Phase 3 N=675 Efficacy and Safety of Acupuncture for Functional Constipation
Constipation
Primary: Change of the SBMs From Baseline at Week 4 — 2.7; 2.7; 2.2; 2.4 times per week — p=0.352
N/A N=12 Proof of Concept: "Bottom's Up" Seat to Treat Constipation
Constipation Aggravated · Pelvic Floor; Incompetency
Primary: Adverse Events — 0 Participants
Phase 3 N=438 Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC)
Functional Constipation · Irritable Bowel Syndrome With Constipation
Primary: Functional Constipation (FC) Participants: Change From Baseline in 12-week SBM (Spontaneous Bowel Movement) Frequency Rate (SBMs/Week) During the Study Intervention…
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 2 N=35 Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation
Functional Constipation
Primary: Change From Baseline in 4-week Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Study Intervention Period of Each Cohort — 1.379; 0.621…
Phase 3 N=87 Evaluation of the Safety of Lubiprostone in Pediatric Participants Aged ≥ 6 Years to < 18 Years With Functional Constipation
Constipation - Functional
Primary: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) — 47 Participants
N/A N=84 Effect of Preoperative Fiber on Postoperative Bowel Function
Constipation · Prolapse, Vaginal
Primary: Time to First Bowel Movement After Surgery — 66.5; 68.3 hours
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
N/A N=158 Clinical Improvement and in Quality of Life-Functional Dyspepsia-
Psychogenic Dyspepsia
Primary: Change From Baseline in DYSPEPSIA RELATED HEALTH SCALE (DRHS) — 73.72; 65.31; 71.85; 64.89 units on a scale
N/A N=102 Maintenance Treatment for Children With Constipation
Constipation
Primary: Treatment Recovery — 33; 19 participants — p=0.024
N/A N=22 Effect of Inulin-type Fructans on Constipated Children.
Constipation
Primary: Stool Consistency — 2.57; 1.63 units on a scale
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 3 N=381 Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C
Irritable Bowel Syndrome With Constipation · Functional Constipation
Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs). — 37; 15; 4; 31 Participants
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