| March 20, 2006 |
| March 22, 2009 |
| March 2006 |
| |
| Safety will be evaluated on an ongoing basis by completing physical examinations, ECGs, clinical laboratory tests, and adverse event reporting. |
| Same as current |
| Complete list of historical versions of study NCT00306748 on ClinicalTrials.gov Archive Site |
- Stool Frequency will be reported daily
- Stool Consistency (Bristol Stool Form Scale) will be reported daily
- Stool Ease of Passage will be reported daily
- Stool Completeness of Evacuation will be reported daily
- Patient Assessment of Abdominal Discomfort will be reported weekly
- Patient Assessment of Constipation will be reported weekly
- Patient Assessment of Overall Relief will be reported weekly
- Part 1 of the Irritable Bowel Symptom Severity Scale (IBSSS) will be reported once pre-dose and once post-dose.
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- Patients will report a number of outcomes during the study:
- Stool Frequency will be reported daily.
- Stool Consistency (Bristol Stool Form Scale) will be reported daily.
- Stool Ease of Passage will be reported daily.
- Stool Completeness of Evacuation will be reported daily.
- Patient Assessment of Abdominal Discomfort will be reported weekly.
- Patient Assessment of Constipation will be reported weekly.
- Patient Assessment of Overall Relief will be reported weekly.
- Part 1 of the Irritable Bowel Symptom Severity Scale (IBSSS) will be reported once pre-dose and once post-dose.
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| |
| Phase 2 Study of MD-1100 Acetate Administered for 14 Days to Patients Meeting Criteria for Chronic Constipation |
| A Randomized, Multicenter, Double-Blind, Parallel-Design, Phase 2 Trial of Oral MD-1100 Acetate Administered for 14 Days Once Daily at 100 ug, 300 ug, 1000 ug, or Placebo to Patients With Chronic Constipation |
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 II |
| Interventional |
| Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Constipation |
| Drug: MD-1100 Acetate |
| |
| |
| |
| Completed |
| 40 |
| August 2006 |
|
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.
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| Both |
| 18 Years to 70 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00306748 |
|
| MCP-103-004 |
| Ironwood Pharmaceuticals, Inc. |
|
| Study Director: |
Jeffrey M. Johnston, MD, FACP |
Microbia, Inc. |
|
|
| Ironwood Pharmaceuticals, Inc. |
| March 2009 |