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

NCT00258193 | Completed Phase 2

• 1 other identifier: Protocol MCP-103-005
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 patients with C-IBS.
• The secondary objectives of this trial are:
• 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.
• 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

Keywords

C-IBS; IBS-C; Constipation-predominant Irritable Bowel Syndrome; Constipation Predominant Irritable Bowel Syndrome; Irritable Bowel Syndrome; IBS; Transit; Scintigraphy; Gastroenterology; Gastrointestinal; GC; MD-1100 Acetate; MD-1100; linaclotide; linaclotide acetate

Outcome Measures

Primary Outcomes (4)

• (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.

Secondary Outcomes (1)

• Secondary transit endpoints will be gastric emptying t1/2, colonic filling at 6 hours, colonic GC at additional time points including 48 hours, and time to first bowel movement after the first dose of medication.

Interventions

MD-1100 Acetate DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ironwood Pharmaceuticals, Inc.: lead

Study Sites (1)

Mayo Clinic Foundation

Rochester, Minnesota, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

linaclotide

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Michael Camilleri, MD

  Mayo Clinic Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 22, 2005
• First Posted: November 24, 2005
• Study Start: January 1, 2006
• Study Completion: September 1, 2006
• Last Updated: October 20, 2006

Record last verified: 2006-10

Locations

US (1)