NCT00215566CompletedPhase 2
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
Dynogen Pharmaceuticals24 sites in 1 country90 target enrollmentStarted: September 1, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 24
- Primary Endpoint
- Evaluation of the effect of DDP733 on gastrointestinal transit
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Evaluation of the effect of DDP733 on gastrointestinal transit
Secondary Outcomes
- Evaluation of the effect of DDP733 on patient reported outcomes
Investigators
Study Sites (24)
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