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

May 25, 2007 updated by: Dynogen Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1S 4L8
        • Hopital St-Sacrement
    • Alberta
      • Edmonton, Alberta, Canada, T5H 4B9
        • Hys Medical Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St Paul's Hospital
      • West Vancouver, British Columbia, Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • QE II Health Sciences Centre
    • Ontario
      • Guelph, Ontario, Canada
        • Surrey GI Clinic
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster University Medical Centre
      • Kingston, Ontario, Canada, K7L 5G2
        • Hotel Dieu Hospital
      • London, Ontario, Canada, N6A 4V2
        • St. Joseph's Healthcare
      • Ottawa, Ontario, Canada
        • Meadowlands Family Health Centre
      • Sarnia, Ontario, Canada
        • London Road Diagnostic Clinic
      • Sarnia, Ontario, Canada
        • Sarnia Institute of Clinical Research
      • Toronto, Ontario, Canada, M3H 5S4
        • Canadian Phase Onward Inc.
      • Toronto, Ontario, Canada, M3N 2V7
        • Toronto Digestive Disease Associates, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Evaluation of the effect of DDP733 on gastrointestinal transit

Secondary Outcome Measures

Outcome Measure
Evaluation of the effect of DDP733 on patient reported outcomes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dynogen Pharmaceuticals

Investigators

  • Study Chair: William Paterson, MD, Hotel Dieu Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Registration Dates

First Submitted

September 19, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (ESTIMATE)

September 22, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

May 28, 2007

Last Update Submitted That Met QC Criteria

May 25, 2007

Last Verified

March 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DDP733-04-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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