Clinical Trial Search

Primary: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With…

Primary: Weekly Response for Abdominal Pain Intensity AND Stool Consistency Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks). — 35.7; 34.7…

Primary: Repeat Treatment Responders — 32.6; 25.0 percentage of patients — p=0.0232

Primary: Change in Mean Daily Abdominal Pain — 5.2; 5.3; 3.9; 3.8 score on a scale — p=0.78

Primary: Changes in GIS Scores Between Baseline and After a 12 Week Intervention With Mesalamine or Placebo — 2.72; 2.22 units on a scale — p=.001

Primary: The Number of Months That Subjects Are Monthly Responders in Both IBS-related Abdominal Pain AND Stool Consistency During the Entire Three Months. — 18; 27; 28; 9…

Primary: Change in the Bowel Movements (Stool Frequency) Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. — .46; .21 bowel movements/day

Primary: Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores — 22.7…

Primary: Change From Baseline in Abdominal Pain at Its Worst on a NRS Through the Treatment Period — -2.01; -1.93; -1.58; -1.95 units on a scale — p=0.7467

Primary: Within and Between Group Comparisons of Disease Severity as Determined by Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS) — 282; 309; 221; 236 units on a scale

Primary: Response of Overall IBS Symptom Relief - 50% Rule — 79; 61; 61; 78 Participants

Primary: Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6). — 31.2…

Primary: Number of Subjects Reporting "Adequate Relief" From IBS Symptoms for the Previous Week. Adequate Relief Was a "True/False" Item. — 13 Participants

Primary: Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores at Week 4…

Primary: Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6). — 32.2…

Primary: Abdominal Pain, as Determined by Daily Pain Diaries (Patterned After Item 3 From the Brief Pain Inventory; Cleeland and Ryan, 1994). — -1.5 Units on a scale — p=<0.001

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

Primary: Colonic Compliance at Pressure at Half-Maximum Volume (Pr 1/2) — 17.57; 16.2; 18.76 mL/mm Hg

Primary: 24-hour Worst Abdominal Pain Scores (WAP) at Day 29 Compared to Baseline (Averaged Over the Week Prior to Each Respective Time Point) — -1.64; -2.30; -2.00; -1.69 Score…

Primary: Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores — 28.9…

Primary: Number of Irritable Bowel Syndrome (IBS) With Predominantly Diarrhea (IBS-D) Participants Who Were Abdominal Pain Intensity (API) Weekly Responders at Week 12 — 27; 27…

Primary: Change From Baseline in Average Bristol Stool Form Scale (BSFS) Score Over 4 Weeks of Treatment Period — 5.89; 5.34; -1.25; -1.09 score on a scale

Primary: Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores — 23.9…

Primary: Summary and Analysis of Overall Stool Consistency Response Rate - mITT Population — 42; 18; 33; 33 Participants — p=0.036

Primary: Abdominal Pain Intensity Responder — 55; 49 Participants — p=0.5352

Primary: Complete Spontaneous Bowel Movement (CSBM) Frequency Change From Baseline — 1.01; 1.50; 1.54; 1.57 number of bowel movements/week

Primary: Change in the Irritable Bowel Symptom Severity Scale — 181; 301 units on a scale

Primary: Number of Overall Responders - ITT Population — 63; 106; 103 Participants

Primary: Montgomery-Asberg Depression Rating Scale (MADRS) — 31.59; 15.67; 11.4 units on a scale — p=<.05

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