Status:
COMPLETED
Phase 2 Study of MD-1100 Acetate on Gastrointestinal Transit in Patients With C-IBS
Lead Sponsor:
Ironwood Pharmaceuticals, Inc.
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
* The primary objective of this trial is to compare the dose-ranging pharmacodynamic effects of orally administered placebo, and 100 and 1000 ug qd of MD-1100 Acetate on gastrointestinal transit in pa...
Detailed Description
Using a double-blind, randomized, placebo-controlled, parallel group study design, the effects of placebo and two different doses of orally administered MD-1100 Acetate on gastric emptying, small bowe...
Eligibility Criteria
Inclusion
- Patient agrees to use a medically accepted, double-barrier form of contraception (e.g., IUD and condom) during participation;
- No evidence of pelvic floor dysfunction and the completion of a negative digital rectal exam prior to the first dose of study medication;
- Absence of an evacuation disorder as defined per protocol;
- Patients must meet ROME II Criteria for C-IBS;
- The patient's Baseline Colonic Transit Test must show a geometric center (GC) ≤ 2.65 at 24 hours, or ≤ 3.0 at 24 hours and ≤ 3.9 at 48 hours.
Exclusion
- History of clinically-significant manifestations of any major system organ class;
- History of inflammatory bowel disease or gastric ulcers;
- Significant GI surgery within 6 months;
- Clinically-significant prolonged diarrhea within 60 days;
- Special dietary habit and/or an intense physical workout program within 4 weeks;
- Certain drug hypersensitivities
- History of alcoholism or drug addiction within 12 months;
- Receipt of an investigational drug during the study or within 30 days;
- Use of any prescription medication or OTC, non-prescription medications disallowed by the protocol within 7 days.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00258193
Start Date
January 1 2006
End Date
September 1 2006
Last Update
October 20 2006
Active Locations (1)
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1
Mayo Clinic Foundation
Rochester, Minnesota, United States