Overview

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.