A Study of the Safety and Effectiveness of DDP733 in Treating IBS With Constipation in Females
NCT ID: NCT00547469
Last Updated: 2008-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
360 participants
INTERVENTIONAL
2007-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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DDP733
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
FEMALE
No
Sponsors
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Dynogen Pharmaceuticals
INDUSTRY
Principal Investigators
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Dynogen Study Director, MD
Role: STUDY_DIRECTOR
Dynogen Pharmaceuticals, Inc
Locations
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Alliance Clinical Trials
Birmingham, Alabama, United States
Clinical Research Associates
Huntsville, Alabama, United States
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States
Mobile Medical Diagnostic
Mobile, Alabama, United States
Pivotal Research Centers
Peoria, Arizona, United States
Genova Clinical Research
Tucson, Arizona, United States
Arkansas Gastroenterology
Sherwood, Arkansas, United States
Impact Clinical Trials
Beverly Hills, California, United States
Discovery Clinical Research
Encinitas, California, United States
Family Medical Center
Foothill Ranch, California, United States
Digestive and Liver Disease Specialist, A Medical Group, Inc.
Garden Grove, California, United States
Prime Care Clinical Research, Inc.
Mission Vejo, California, United States
California Research Foundation
San Diego, California, United States
Medical Center for clinical research
San Diego, California, United States
Westlake Medical Research
Westlake Village, California, United States
Clinical Trial Center of Colorado, LLC
Castle Rock, Colorado, United States
Clinical Trials Management of Boca Raton, Inc.
Boca Raton, Florida, United States
Jupiter Research
Jupiter, Florida, United States
AppleMed Research Inc.
Miami, Florida, United States
Accord Clinical Research, LLC
Port Orange, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
Mount Vernon Clinical Research
Atlanta, Georgia, United States
Atlanta Gastroenterology Associates, LLC
Marietta, Georgia, United States
North Georgia Clinical Research
Woodstock, Georgia, United States
Rosemark WomenCare Specialists
Idaho Falls, Idaho, United States
Accelovance
Peoria, Illinois, United States
Rockford Gastroenterology Associates, Ltd.
Rockford, Illinois, United States
Indiana Medical Research, LLC
Elkhart, Indiana, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
Metropolitan Gastroenterology Group, PC Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Maryland Digestive Disease Research, LLC
Laurel, Maryland, United States
Boston Clinical Trials, INC.
Boston, Massachusetts, United States
Women's Health Care Specialists, PC
Paw Paw, Michigan, United States
CRC of Jackson, LLC at Jackson Medical Clinic
Jackson, Mississippi, United States
Gastrointestinal Associates, P.A.
Jackson, Mississippi, United States
Center for Digestive and Liver Diseases, Inc.
Mexico, Missouri, United States
Lovelace Scientific Resources
Henderson, Nevada, United States
LifeLine Research, Inc.
Brooklyn, New York, United States
UNC Center for Functional GI and Motility Disorders
Chapel Hill, North Carolina, United States
Peters Medical Research dba Bethany Medical Center
High Point, North Carolina, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
Piedmont Medical Research Associates
Winston-Salem, North Carolina, United States
Hightop Medical Research Center
Cincinnati, Ohio, United States
Gastroenterology Research Consultants of Greater Cincinnati
Cincinnati, Ohio, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, United States
Gastrointestinal and Liver Diseases Consultants
Dayton, Ohio, United States
Clinical Trials Research Services, LLC
Pittsburgh, Pennsylvania, United States
Southeastern Clinical Research
Chattanooga, Tennessee, United States
Jackson Clinic, PA
Jackson, Tennessee, United States
Regional Research Institute
Jackson, Tennessee, United States
Gastroenterology Associates Clinical Research
Kingsport, Tennessee, United States
Baylor College of Medicine, Baylor Clinic
Houston, Texas, United States
DCOL Center for Research
Longview, Texas, United States
Advanced Research Institute
Ogden, Utah, United States
Virginia Mason Meidical Center
Seattle, Washington, United States
Rowan Research
Spokane, Washington, United States
Spokane Internal Medicine
Spokane, Washington, United States
Wisconsin Center for Advanced Research Division of GI Associates, LLC
Milwaukee, Wisconsin, United States
Aurora Health Center
Waukesha, Wisconsin, United States
McMaster University Dept of Gastrointerology St. Joseph's Healthcare
Hamilton, Ontario, Canada
St. Joseph's Hospital
London, Ontario, Canada
Meadowlands Family Health Center
Ottawa, Ontario, Canada
London Road Diagnostic Clinic
Sarnia, Ontario, Canada
Sarnia Institute of Clinical Research
Sarnia, Ontario, Canada
Canadian Phase Onward Inc.
Toronto, Ontario, Canada
Toronto Digestive Disease Associates, Inc.
Toronto, Ontario, Canada
Countries
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Facility Contacts
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Other Identifiers
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DDP733-07-010
Identifier Type: -
Identifier Source: org_study_id
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