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A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of DDP733 for IBS-c

This study has been completed.
Sponsor:
Information provided by:
Dynogen Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00215566
First received: September 19, 2005
Last updated: May 25, 2007
Last verified: March 2006
History of Changes

September 19, 2005
May 25, 2007
September 2005
Not Provided
Evaluation of the effect of DDP733 on gastrointestinal transit
Same as current
Complete list of historical versions of study NCT00215566 on ClinicalTrials.gov Archive Site
Evaluation of the effect of DDP733 on patient reported outcomes
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of DDP733 for IBS-c
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Multiple Doses and Dose Levels of DDP733 in Patients With Irritable Bowel Syndrome With Constipation

This study will evaluate the safety, tolerability and pharmacodynamics of the investigational drug DDP733 in treating subjects with IBS-c. A placebo control will be utilized.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Irritable Bowel Syndrome With Constipation
  • 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.
 
Completed
90
Not Provided
Not Provided

Inclusion Criteria:

  • Subjects must have a history of IBS-c for at least 3 months prior to randomization as assessed using ROME criteria
  • Must have had endoscopic/radiologic bowel evaluation within the past 10 years
  • Must comply with completing a daily diary and be able to comply with GI transit measurements, including swallowing capsules containing small x-ray visible markers
  • Female subjects cannot be pregnant, post-partum for less than 1 year or breastfeeding

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00215566
DDP733-04-007
Not Provided
Not Provided
Dynogen Pharmaceuticals
Not Provided
Study Chair: William Paterson, MD Hotel Dieu Hospital
Dynogen Pharmaceuticals
March 2006

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