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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.