A Phase 2 interventional study of Asimadoline and Placebo in Irritable Bowel Syndrome, sponsored by Tioga Pharmaceuticals. Completed at 112 sites in United States. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2011-10-18.
Sponsored by Tioga Pharmaceuticals · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the safety and efficacy of different doses of asimadoline in the treatment of patients with irritable bowel syndrome.
A randomized, dose-ranging, double-blind, placebo-controlled study designed to evaluate the efficacy and tolerability of three dose levels of asimadoline in subjects with IBS.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 596 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Tioga Pharmaceuticals is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Placebo
Drug: Asimadoline
Drug: Asimadoline
Drug: Asimadoline
Asimadoline was provided in coated tablets of three dosages (0.15 mg, 0.5 mg, and 1.0 mg). All asimadoline tablets used in this trial were synthesized from the same batch of drug substance (Batch EF418492). Asimadoline was administered orally, BID for 12 weeks
Also known as: EMD 61753, EMR 63320
Placebo was provided in coated tablets identical in appearance to asimadoline tablets.
Relief of IBS Pain - total months
The primary efficacy endpoint of the study was the total number of months with adequate relief of IBS pain or discomfort.
Time frame: 12 weeks
Relief of IBS Pain - percent of patients
Proportion of subjects with adequate relief of IBS pain or discomfort
Time frame: 12 weeks
Relief of IBS Symptoms
Adequate relief of IBS symptoms
Time frame: 12 weeks
Lower GI function - change from baseline
Change from baseline in assessments of lower gastrointestinal (GI) function (i.e., stool frequency, stool consistency, urgency, bloating, and straining)
Time frame: 12 weeks
Abdominal Pain Score - change from baseline
Change from baseline in abdominal pain score
Time frame: 12 weeks
Abdominal Discomfort Score - change from baseline
Change from baseline in abdominal discomfort score
Time frame: 12 weeks
Showing the first 100 of 112 sites.
This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
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Tioga Pharmaceuticals