A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of DDP733 for IBS-c
Phase 2
Completed
- Conditions
- Irritable Bowel Syndrome With ConstipationIrritable Bowel Syndrome
- Registration Number
- NCT00215566
- Lead Sponsor
- Dynogen Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Evaluation of the effect of DDP733 on gastrointestinal transit
- Secondary Outcome Measures
Name Time Method Evaluation of the effect of DDP733 on patient reported outcomes
Trial Locations
- Locations (13)
Hys Medical Centre
🇨🇦Edmonton, Alberta, Canada
St Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
QE II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
Surrey GI Clinic
🇨🇦Guelph, Ontario, Canada
McMaster University Medical Centre
🇨🇦Hamilton, Ontario, Canada
St. Joseph's Healthcare
🇨🇦London, Ontario, Canada
Hotel Dieu Hospital
🇨🇦Kingston, Ontario, Canada
Meadowlands Family Health Centre
🇨🇦Ottawa, Ontario, Canada
London Road Diagnostic Clinic
🇨🇦Sarnia, Ontario, Canada
Sarnia Institute of Clinical Research
🇨🇦Sarnia, Ontario, Canada
Scroll for more (3 remaining)Hys Medical Centre🇨🇦Edmonton, Alberta, Canada