Phase 2 Study of MD-1100 Acetate on Gastrointestinal Transit in Patients With C-IBS

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

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 patients with C-IBS.

• The secondary objectives of this trial are:

1. To compare the dose ranging pharmacodynamic effects of placebo, and 100 and 1000 ug MD-1100 Acetate once daily on time to first bowel movement after first drug intake.

2. To describe and summarize the effects of placebo, and 100 and 1000 ug MD-1100 Acetate once daily on stool frequency, stool consistency, ease of passage and sensation of incomplete evacuation during the Treatment Period relative to Baseline.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ironwood Pharmaceuticals, Inc.
• Treatments: Linaclotide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.