Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258193
Status:
COMPLETED
Last Update Posted:
2006-10-20
First Post:
2005-11-22
Brief Title:
Phase 2 Study of MD-1100 Acetate on Gastrointestinal Transit in Patients With C-IBS
Sponsor:
Ironwood Pharmaceuticals Inc
Organization:
Ironwood Pharmaceuticals Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2006-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Detailed Description:
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 265 at 24 hours or 30 at 24 hours and 39 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 n36 patients will be randomized to one of three different treatment groups placebo n12 100 ug MD-1100 n12 or 1000 ug MD-1100 n12 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
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 265 at 24 hours or 30 at 24 hours and 39 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 n36 patients will be randomized to one of three different treatment groups placebo n12 100 ug MD-1100 n12 or 1000 ug MD-1100 n12 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None