Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of DDP733 for IBS-c
Lead Sponsor:
Dynogen Pharmaceuticals
Conditions:
Irritable Bowel Syndrome With Constipation
Irritable Bowel Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00215566
Start Date
September 1 2005
Last Update
May 28 2007
Active Locations (15)
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1
Hys Medical Centre
Edmonton, Alberta, Canada, T5H 4B9
2
St Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
3
West Vancouver, British Columbia, Canada
4
QE II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 2Y9