Status:
COMPLETED
Phase 2 Study of MD-1100 Acetate Administered for 14 Days to Patients Meeting Criteria for Chronic Constipation
Lead Sponsor:
Ironwood Pharmaceuticals, Inc.
Conditions:
Constipation
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the safety and gastrointestinal pharmacodynamics (stool frequency, stool consistency, stool ease of passage, stool completeness of evacuation) of MD-1100 acet...
Eligibility Criteria
Inclusion
- Male or non-pregnant, non-breastfeeding female, age 18-70 years old at the time of first dose;
- Sexually active patients of childbearing potential agree to use double-barrier birth control;
- Females of childbearing potential must complete negative pregnancy tests prior to first dose;
- Negative colonoscopy within 10 years or completion of negative flexible sigmoidoscopy if under the age of 50 provided there is no history of rectal bleeding, weight loss, or anemia;
- BMI must be greater than/equal to 18.5 and less than 35.0;
- Successful completion of physical exam, 12-lead ECG, clinical laboratory tests prior to first dose of study medication;
- Vital signs must not have clinically-significant findings within 4 hours of first dose of study medication;
- Patient reports 3 or less spontaneous bowel movements (SBMs) per week and meets 1 or more of the following criteria for constipation for 12 weeks in the previous 12 months: straining at least 25% bowel movements (BMs), lumpy or hard stools at least 25% of BMs, or sensation of incomplete evacuation at least 25% of BMs;
- Patient reports 3 or less SBMs during the 7-day Pre-treatment Period;
- Patient is compliant with IVRS for at least 6 days in the 7-day Pre-treatment Period.
Exclusion
- Use of investigational drug within 30 days;
- Laxative/enema-induced diarrhea within 60 days;
- Patient meets ROME II criteria for functional diarrhea;
- Most bothersome symptom is moderate or severe abdominal pain or abdominal discomfort;
- History of cancer, inflammatory bowel disease, ischemic colitis, bowel resection, colostomy, or fecal impaction;
- Diagnosis of cathartic colon or laxative/enema abuse, pelvic floor dysfunction, evacuation disorder, bulimia, anorexia, or neurological disorders;
- Surgery within 30 days or GI surgery within 6 months of first dose of study medication. Cholecystectomy and/or appendectomy are acceptable if completed more than 60 days prior to first dose of study medication;
- Patient may not use any disallowed medications (prescription and/or over-the-counter treatments for chronic constipation or C-IBS, drugs that target 5-HT4, 5-HT2b, or 5-HT3 receptors, narcotics, anti-cholinergic agents, GI preparations, etc.) during the 7-day Pre-treatment Period or during the study. Stable, continuous (30 days or more) use of dietary fiber is acceptable.
- Any acute or chronic condition that would limit the patient's ability to complete and/or participate in the study.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00306748
Start Date
March 1 2006
End Date
August 1 2006
Last Update
March 24 2009
Active Locations (14)
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1
Clinical Research Associates
Huntsville, Alabama, United States, 35801
2
Arkansas Gastroenterology
North Little Rock, Arkansas, United States, 72117
3
Consultants for Clinical Research of South Florida
Boynton Beach, Florida, United States, 33426
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215