Trial | NCT00215566  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    90
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 Started
Sep 30
2005
Last Update
May 28
2007
Estimate

Drug DDP733

Criteria 

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
No Results Posted