Phase 2 Study of MD-1100 Acetate Administered for 14 Days to Patients Meeting Criteria for Chroni… (NCT00306748) | Clinical Trial Compass
CompletedPhase 2
Phase 2 Study of MD-1100 Acetate Administered for 14 Days to Patients Meeting Criteria for Chronic Constipation
United States40 participantsStarted 2006-03
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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 abdomin…
What they're measuring
1
Safety will be evaluated on an ongoing basis by completing physical examinations, ECGs, clinical laboratory tests, and adverse event reporting.