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

The recruitment status of this study is unknown because the information has not been verified recently.
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

October 19, 2007
April 7, 2008
October 2007
Not Provided
Overall Subject Global Assessment (SGA) of relief of IBS symptoms, collected weekly
Same as current
Complete list of historical versions of study NCT00547469 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
A Study of the Safety and Effectiveness of DDP733 in Treating IBS With Constipation in Females
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Effectiveness of DDP733 in Female Patients With Irritable Bowel Syndrome With Constipation

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Irritable Bowel Syndrome
Drug: DDP733
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
360
Not Provided
Not Provided

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
Female
18 Years to 65 Years
No
United States,   Canada
 
NCT00547469
DDP733-07-010
Yes
Not Provided
Dynogen Pharmaceuticals
Not Provided
Study Director: Dynogen Study Director, MD Dynogen Pharmaceuticals, Inc
Dynogen Pharmaceuticals
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP