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Sponsored by: |
Ironwood Pharmaceuticals, Inc. |
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Information provided by: | Ironwood Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00258193 |
The secondary objectives of this trial are:
Condition | Intervention | Phase |
---|---|---|
Irritable Bowel Syndrome |
Drug: MD-1100 Acetate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | 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) |
Estimated Enrollment: | 36 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | September 2006 |
Using a double-blind, randomized, placebo-controlled, parallel group study design, the effects of placebo and two different doses of orally administered MD-1100 Acetate on gastric emptying, small bowel transit and total colonic transit will be compared and evaluated in patients with C-IBS.
After eligibility is confirmed, the patient will return for baseline measurement of colonic transit to ensure that the transit profile is not greater than the mean transit profile of healthy controls in order to avoid a ceiling effect. A patient must have a geometric center of ≤2.65 at 24 hours, or ≤3.0 at 24 hours and ≤3.9 at 48 hours in order to be randomized to a 5-day Treatment Period of study medication. Eligible patients will receive oral study medication for 5 days during which colonic transit will be measured.
Approximately 36 (n=36) patients will be randomized to one of three different treatment groups: placebo (n=12), 100 ug MD-1100 (n=12), or 1000 ug MD-1100 (n=12). All dosing of study medication will be supervised at the Mayo Clinic.
Patients will complete a daily Stool Diary to record bowel habits for 5 consecutive days during the Pretreatment Period and then for the 5 consecutive days of the Treatment PeriodPhysical examinations, vital signs, electrocardiograms, and clinical laboratory tests will be performed throughout the study and adverse events will be recorded for safety evaluation.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Minnesota | |
Mayo Clinic Foundation | |
Rochester, Minnesota, United States |
Principal Investigator: | Michael Camilleri, MD | Mayo Clinic Foundation |
Study ID Numbers: | Protocol MCP-103-005 |
Study First Received: | November 22, 2005 |
Last Updated: | October 19, 2006 |
ClinicalTrials.gov Identifier: | NCT00258193 |
Health Authority: | United States: Food and Drug Administration |
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 |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Irritable Bowel Syndrome |
Constipation Intestinal Diseases Colonic Diseases, Functional |
Pathologic Processes Disease Syndrome |