A Study of the Safety and Effectiveness of DDP733 in Treating IBS With Constipation in Females
- Conditions
- Irritable Bowel Syndrome
- Registration Number
- NCT00547469
- Lead Sponsor
- Dynogen Pharmaceuticals
- Brief Summary
This study will evaluate the safety and effectiveness of the investigational drug DDP733 in treating female patients with IBS-c. A placebo control will be utilized.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 360
-
Female from 18 to 65 years of age, inclusive
-
Patient experiences recurrent abdominal pain or discomfort at least 3 days per month for the last 3 months with symptom onset at least 6 months prior to diagnosis. The patient's symptoms must be associated with 1 or more of the following:
- Improvement with defecation
- Onset associated with a change in frequency of stool
- Onset associated with a change in form (appearance) of stool
-
Negative serum and urine pregnancy tests
-
Completion of at least six days of daily diary assessments using a phone-in information system prior to randomization
- Serious underlying diseases, including psychiatric disorders
- Current history of conditions affecting bowel transit
- Recent history of biochemical or structural abnormalities of the gastrointestinal tract, gastrointestinal surgery, or gastrointestinal infection
- Clinically significant abnormal examination findings or laboratory tests
- Inability to stop taking certain medications, or a planned change in medications (including herbal remedies) which could interfere with study assessments
- Use of drugs and or ethanol which may interfere with compliance of study procedures or influence study outcome
- Presence of a medical condition which could interfere with the interpretation of study data
- Significant use of nicotine or caffeine
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Overall Subject Global Assessment (SGA) of relief of IBS symptoms, collected weekly
- Secondary Outcome Measures
Name Time Method Weekly assessments of abdominal discomfort/pain, bowel habit, and satisfaction with bowel habit. Other secondary efficacy variables reflecting IBS symptoms include daily assessments of abdominal discomfort/pain; abdominal bloating, the number and consistency of stools, straining at defecation, and feeling of incomplete evacuation.
Trial Locations
- Locations (69)
Indiana Medical Research, LLC
🇺🇸Elkhart, Indiana, United States
Gastroenterology Associates Clinical Research
🇺🇸Kingsport, Tennessee, United States
Maryland Digestive Disease Research, LLC
🇺🇸Laurel, Maryland, United States
Mount Vernon Clinical Research
🇺🇸Atlanta, Georgia, United States
AppleMed Research Inc.
🇺🇸Miami, Florida, United States
Baylor College of Medicine, Baylor Clinic
🇺🇸Houston, Texas, United States
Heartland Research Associates, LLC
🇺🇸Wichita, Kansas, United States
Gastroenterology Research Consultants of Greater Cincinnati
🇺🇸Cincinnati, Ohio, United States
Clinical Trial Center of Colorado, LLC
🇺🇸Castle Rock, Colorado, United States
Arkansas Gastroenterology
🇺🇸Sherwood, Arkansas, United States
Westlake Medical Research
🇺🇸Westlake Village, California, United States
Clinical Research Associates
🇺🇸Huntsville, Alabama, United States
California Research Foundation
🇺🇸San Diego, California, United States
Discovery Clinical Research
🇺🇸Encinitas, California, United States
Atlanta Gastroenterology Associates, LLC
🇺🇸Marietta, Georgia, United States
Pivotal Research Centers
🇺🇸Peoria, Arizona, United States
Mobile Medical Diagnostic
🇺🇸Mobile, Alabama, United States
Clinical Trials Management of Boca Raton, Inc.
🇺🇸Boca Raton, Florida, United States
Medical Affiliated Research Center, Inc.
🇺🇸Huntsville, Alabama, United States
Metropolitan Gastroenterology Group, PC Chevy Chase Clinical Research
🇺🇸Chevy Chase, Maryland, United States
Rosemark WomenCare Specialists
🇺🇸Idaho Falls, Idaho, United States
LifeLine Research, Inc.
🇺🇸Brooklyn, New York, United States
Gastrointestinal and Liver Diseases Consultants
🇺🇸Dayton, Ohio, United States
Wake Research Associates, LLC
🇺🇸Raleigh, North Carolina, United States
McMaster University Dept of Gastrointerology St. Joseph's Healthcare
🇨🇦Hamilton, Ontario, Canada
Gastrointestinal Associates, P.A.
🇺🇸Jackson, Mississippi, United States
Rapid Medical Research, Inc.
🇺🇸Cleveland, Ohio, United States
Piedmont Medical Research Associates
🇺🇸Winston-Salem, North Carolina, United States
UNC Center for Functional GI and Motility Disorders
🇺🇸Chapel Hill, North Carolina, United States
Boston Clinical Trials, INC.
🇺🇸Boston, Massachusetts, United States
Hightop Medical Research Center
🇺🇸Cincinnati, Ohio, United States
DCOL Center for Research
🇺🇸Longview, Texas, United States
Canadian Phase Onward Inc.
🇨🇦Toronto, Ontario, Canada
St. Joseph's Hospital
🇨🇦London, Ontario, Canada
Virginia Mason Meidical Center
🇺🇸Seattle, Washington, United States
Peters Medical Research dba Bethany Medical Center
🇺🇸High Point, North Carolina, United States
Jackson Clinic, PA
🇺🇸Jackson, Tennessee, United States
Aurora Health Center
🇺🇸Waukesha, Wisconsin, United States
Meadowlands Family Health Center
🇨🇦Ottawa, Ontario, Canada
Toronto Digestive Disease Associates, Inc.
🇨🇦Toronto, Ontario, Canada
Medical Center for clinical research
🇺🇸San Diego, California, United States
Accelovance
🇺🇸Peoria, Illinois, United States
Rockford Gastroenterology Associates, Ltd.
🇺🇸Rockford, Illinois, United States
Family Medical Center
🇺🇸Foothill Ranch, California, United States
Jupiter Research
🇺🇸Jupiter, Florida, United States
Accord Clinical Research, LLC
🇺🇸Port Orange, Florida, United States
Center for Digestive and Liver Diseases, Inc.
🇺🇸Mexico City, Missouri, United States
North Georgia Clinical Research
🇺🇸Woodstock, Georgia, United States
Women's Health Care Specialists, PC
🇺🇸Paw Paw, Michigan, United States
Wisconsin Center for Advanced Research Division of GI Associates, LLC
🇺🇸Milwaukee, Wisconsin, United States
Spokane Internal Medicine
🇺🇸Spokane, Washington, United States
Rowan Research
🇺🇸Spokane, Washington, United States
Alliance Clinical Trials
🇺🇸Birmingham, Alabama, United States
Digestive and Liver Disease Specialist, A Medical Group, Inc.
🇺🇸Garden Grove, California, United States
MediSphere Medical Research Center, LLC
🇺🇸Evansville, Indiana, United States
Prime Care Clinical Research, Inc.
🇺🇸Mission Vejo, California, United States
Advanced Research Institute
🇺🇸Ogden, Utah, United States
Clinical Trials Research Services, LLC
🇺🇸Pittsburgh, Pennsylvania, United States
Sarnia Institute of Clinical Research
🇨🇦Sarnia, Ontario, Canada
CRC of Jackson, LLC at Jackson Medical Clinic
🇺🇸Jackson, Mississippi, United States
Louisiana Research Center, LLC
🇺🇸Shreveport, Louisiana, United States
Genova Clinical Research
🇺🇸Tucson, Arizona, United States
Southeastern Clinical Research
🇺🇸Chattanooga, Tennessee, United States
Lovelace Scientific Resources
🇺🇸Henderson, Nevada, United States
Regional Research Institute
🇺🇸Jackson, Tennessee, United States
Impact Clinical Trials
🇺🇸Beverly Hills, California, United States
Stedman Clinical Trials
🇺🇸Tampa, Florida, United States
London Road Diagnostic Clinic
🇨🇦Sarnia, Ontario, Canada
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States