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A Study of the Safety and Effectiveness of DDP733 in Treating IBS With Constipation in Females

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2008 by Dynogen Pharmaceuticals.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Dynogen Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00547469
First received: October 19, 2007
Last updated: April 7, 2008
Last verified: April 2008
  Purpose
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.

Condition Intervention Phase
Irritable Bowel Syndrome
Drug: DDP733
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Effectiveness of DDP733 in Female Patients With Irritable Bowel Syndrome With Constipation

Resource links provided by NLM:


Further study details as provided by Dynogen Pharmaceuticals:

Primary Outcome Measures:
  • Overall Subject Global Assessment (SGA) of relief of IBS symptoms, collected weekly

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 360
Study Start Date: October 2007
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547469

  Hide Study Locations
Locations
United States, Alabama
Alliance Clinical Trials
Birmingham, Alabama, United States, 35215
Clinical Research Associates
Huntsville, Alabama, United States, 35801
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States, 35801
Mobile Medical Diagnostic
Mobile, Alabama, United States, 36617
United States, Arizona
Pivotal Research Centers
Peoria, Arizona, United States, 85381
Genova Clinical Research
Tucson, Arizona, United States, 85741
United States, Arkansas
Arkansas Gastroenterology
Sherwood, Arkansas, United States, 72120
United States, California
Impact Clinical Trials
Beverly Hills, California, United States, 90211
Discovery Clinical Research
Encinitas, California, United States, 92024
Family Medical Center
Foothill Ranch, California, United States, 92610
Digestive and Liver Disease Specialist, A Medical Group, Inc.
Garden Grove, California, United States, 92840
Prime Care Clinical Research, Inc.
Mission Vejo, California, United States, 92691
California Research Foundation
San Diego, California, United States, 92103
Medical Center for clinical research
San Diego, California, United States, 92108
Westlake Medical Research
Westlake Village, California, United States, 91361
United States, Colorado
Clinical Trial Center of Colorado, LLC
Castle Rock, Colorado, United States, 80108
United States, Florida
Clinical Trials Management of Boca Raton, Inc.
Boca Raton, Florida, United States, 33486
Jupiter Research
Jupiter, Florida, United States, 33458
AppleMed Research Inc.
Miami, Florida, United States, 33155
Accord Clinical Research, LLC
Port Orange, Florida, United States, 32129
Stedman Clinical Trials
Tampa, Florida, United States, 33613
United States, Georgia
Mount Vernon Clinical Research
Atlanta, Georgia, United States, 30328
Atlanta Gastroenterology Associates, LLC
Marietta, Georgia, United States, 30067
North Georgia Clinical Research
Woodstock, Georgia, United States, 30189
United States, Idaho
Rosemark WomenCare Specialists
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Accelovance
Peoria, Illinois, United States, 61602
Rockford Gastroenterology Associates, Ltd.
Rockford, Illinois, United States, 61107
United States, Indiana
Indiana Medical Research, LLC
Elkhart, Indiana, United States, 46514
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States, 47714
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67203
United States, Louisiana
Louisiana Research Center, LLC
Shreveport, Louisiana, United States, 71103
United States, Maryland
Metropolitan Gastroenterology Group, PC Chevy Chase Clinical Research
Chevy Chase, Maryland, United States, 20815
Maryland Digestive Disease Research, LLC
Laurel, Maryland, United States, 20707
United States, Massachusetts
Boston Clinical Trials, INC.
Boston, Massachusetts, United States, 02135
United States, Michigan
Women's Health Care Specialists, PC
Paw Paw, Michigan, United States, 49079
United States, Mississippi
CRC of Jackson, LLC at Jackson Medical Clinic
Jackson, Mississippi, United States, 39202
Gastrointestinal Associates, P.A.
Jackson, Mississippi, United States, 39202
United States, Missouri
Center for Digestive and Liver Diseases, Inc.
Mexico City, Missouri, United States, 65265
United States, Nevada
Lovelace Scientific Resources
Henderson, Nevada, United States, 89014
United States, New York
LifeLine Research, Inc.
Brooklyn, New York, United States, 11214
United States, North Carolina
UNC Center for Functional GI and Motility Disorders
Chapel Hill, North Carolina, United States, 27514
Peters Medical Research dba Bethany Medical Center
High Point, North Carolina, United States, 27262
Wake Research Associates, LLC
Raleigh, North Carolina, United States, 27612
Piedmont Medical Research Associates
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Hightop Medical Research Center
Cincinnati, Ohio, United States, 45224
Gastroenterology Research Consultants of Greater Cincinnati
Cincinnati, Ohio, United States, 45242
Rapid Medical Research, Inc.
Cleveland, Ohio, United States, 44122
Gastrointestinal and Liver Diseases Consultants
Dayton, Ohio, United States, 45440
United States, Pennsylvania
Clinical Trials Research Services, LLC
Pittsburgh, Pennsylvania, United States, 15206
United States, Tennessee
Southeastern Clinical Research
Chattanooga, Tennessee, United States, 37403
Jackson Clinic, PA
Jackson, Tennessee, United States, 38301
Regional Research Institute
Jackson, Tennessee, United States, 38305
Gastroenterology Associates Clinical Research
Kingsport, Tennessee, United States, 37660
United States, Texas
Baylor College of Medicine, Baylor Clinic
Houston, Texas, United States, 77030
DCOL Center for Research
Longview, Texas, United States, 75605
United States, Utah
Advanced Research Institute
Ogden, Utah, United States, 84405
United States, Washington
Virginia Mason Meidical Center
Seattle, Washington, United States, 98101
Rowan Research
Spokane, Washington, United States, 99207
Spokane Internal Medicine
Spokane, Washington, United States, 99216
United States, Wisconsin
Wisconsin Center for Advanced Research Division of GI Associates, LLC
Milwaukee, Wisconsin, United States, 53215
Aurora Health Center
Waukesha, Wisconsin, United States, 53186
Canada, Ontario
McMaster University Dept of Gastrointerology St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N4A6
St. Joseph's Hospital
London, Ontario, Canada, N6A 4V2
Meadowlands Family Health Center
Ottawa, Ontario, Canada, K2C 3R2
London Road Diagnostic Clinic
Sarnia, Ontario, Canada, N7T4X3
Sarnia Institute of Clinical Research
Sarnia, Ontario, Canada, N7T4X3
Canadian Phase Onward Inc.
Toronto, Ontario, Canada, M3H 5S4
Toronto Digestive Disease Associates, Inc.
Toronto, Ontario, Canada, M3N2V7
Sponsors and Collaborators
Dynogen Pharmaceuticals
Investigators
Study Director: Dynogen Study Director, MD Dynogen Pharmaceuticals, Inc
  More Information

ClinicalTrials.gov Identifier: NCT00547469     History of Changes
Other Study ID Numbers: DDP733-07-010 
Study First Received: October 19, 2007
Last Updated: April 7, 2008
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Dynogen Pharmaceuticals:
Irritable Bowel Syndrome
IBS-c
IBS constipation
women with IBS
women with constipation

Additional relevant MeSH terms:
Syndrome
Constipation
Irritable Bowel Syndrome
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on December 08, 2016