Phase 2 Study of MD-1100 Acetate on Gastrointestinal Transit in Patients With C-IBS
- 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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)|
- (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 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.
|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.
|United States, Minnesota|
|Mayo Clinic Foundation|
|Rochester, Minnesota, United States|
|Principal Investigator:||Michael Camilleri, MD||Mayo Clinic Foundation|