NCT00258193

A Phase 2 Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study of the Pharmacodynamic Effects of Orally Administered 100ug and 1000ug QD MD-1100 Acetate on Gastrointestinal Transit in Patients With Constipation Predominant Irritable Bowel Syndrome (C-IBS)

Completed Phase 2 Last updated 19 October 2006

What this trial tests

Phase 2 trial testing MD-1100 Acetate in Irritable Bowel Syndrome in 36 participants. Completed in 1 September 2006.

Timeline

1 January 2006

1 September 2006

Quick facts

Lead sponsor	Ironwood Pharmaceuticals, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	36
Start date	1 January 2006
Estimated completion	1 September 2006
Sites	1 location across United States

Drugs / interventions tested

• MD-1100 Acetate — full drug profile →

Conditions studied

• Irritable Bowel Syndrome — all drugs for Irritable Bowel Syndrome →

Sponsor

Ironwood Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 18 to 65, any sex, with Irritable Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• (Safety) AEs to be collected beginning with patient's first administration of study medication through final study visit
• Clinical chemistry, hematology, and urinalyses to be performed before and after the Treatment Period
• Cardiac safety will be monitored by ECG recordings
• (Efficacy) Primary endpoints for analysis of efficacy are the colonic geometric center (GC) at 24 hours and ascending colon t1/2 values.

Sponsor's own description

* 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Review article: Linaclotide for the management of irritable bowel syndrome with constipation.
   Layer P, Stanghellini V. · · 2014 · cited 54× · PMID 24433216 · DOI 10.1111/apt.12604