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

NCT00258193 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2006-10-20

No results posted yet for this study

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.

Conditions

  • Irritable Bowel Syndrome

Interventions

DRUG

MD-1100 Acetate

Sponsors & Collaborators

  • Ironwood Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Camilleri, MD · Mayo Clinic Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Completion
2006-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00258193 on ClinicalTrials.gov