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

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

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 acetate administered daily for 14 days.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ironwood Pharmaceuticals, Inc.
• Treatments: Linaclotide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.