Phase 2 Study of MD-1100 Acetate Administered for 14 Days to Patients Meeting Criteria for Chronic Constipation

Completed · Phase 2

Conditions studied: Constipation

In brief

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 acetate administered daily for 14 days.

Key facts

Study ID

NCT00306748

Run by

Ironwood Pharmaceuticals, Inc.

People needed

40

Starts

2006-03-01

Expected to finish

2006-08-01

Last updated by the study team

2009-03-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical Research Associates — Huntsville, Alabama, United States
• Arkansas Gastroenterology — North Little Rock, Arkansas, United States
• Consultants for Clinical Research of South Florida — Boynton Beach, Florida, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Chung H. Kim, MD — Pittsford, New York, United States
• UC for Functional GI & Motility Disorders — Chapel Hill, North Carolina, United States
• Vital Research — Greensboro, North Carolina, United States
• Sooner Clinical Research — Oklahoma City, Oklahoma, United States
• ClinSearch — Chattanooga, Tennessee, United States
• Memphis Gastroenterology Clinic — Germantown, Tennessee, United States
• Austin Gastroenterology, P.A. — Austin, Texas, United States
• Trinity Clinic - Corsicana — Corsicana, Texas, United States
• East Coast Clinical Research, LLC — Virginia Beach, Virginia, United States
• Vantage Clinical Research — Olympia, Washington, United States

Full record on ClinicalTrials.gov

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