DRUG
Phase 2 Study of MD-1100 Acetate Administered for 14 Days to Patients Meeting Criteria for Chronic Constipation
Status
Completed
Phase
Phase 2
Enrollment
40
Locations
14
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Mar 24, 2006
Study start
Mar 2006
Primary completion
Not reported
Study completion
Aug 2006
Results posted
Not reported
Registry updated
Mar 24, 2009
Outcomes
What the study measures.
Primary outcomes
Safety will be evaluated on an ongoing basis by completing physical examinations, ECGs, clinical laboratory tests, and adverse event reporting.
Secondary outcomes
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.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
14 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.