Clinical Trial Search

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: 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: A Change in Length of Spread of Antegrade Contractions After Placebo.

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

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

Primary: Subjects Who Experienced Relief of IBS Pain and Discomfort at Week 4 — 23; 18; 20 Participants

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

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: Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks — 20; 49; 375; 356 Participants — p=0.0004

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

Primary: Overall Responder Rate — 13.8; 7.8 percentage of participants — p=0.029

Primary: Overall Responder Status — 12.1; 5.7 percentage of participants — p=0.023

Primary: Colonic Compliance — 18.96; 16.86; 15.99; 15.75 mm Hg

Primary: Change From Baseline in Colonic Transit Time (CTT) — -727; -15; 366 minutes

Primary: Severity of Constipation in Each Arm at Week 1 After Completion of Therapy — 61.2; 28.6 units on a scale

Primary: Colonic Transit, Colonic Geometric Center at 24 Hours — 2.39; 2.37; 2.02; 1.76 units on a scale

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

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

Primary: Colonic Transit Geometric Center at 24 Hours — 3.12; 3.05; 2.77 units on a scale

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

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

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: Lactulose Mannitol Excretion — 512.5; 394.5; 456.8; 411 micrograms per ml

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: Overall Change From Baseline in Abdominal Score (Abdominal Bloating, Abdominal Discomfort, and Abdominal Pain) Throughout the Treatment Period — -1.182; -1.898 score on…

Primary: Clinical Global Impressions - Improvement Scale (CGI-I; Patient Version) — 68.1; 64.6; 46.7; 64.0 percentage of treatment responders

Primary: Count of Participants Who Self-reported "Adequate Relief" — 12; 15 Participants — p=0.59