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

This study has been completed.
Sponsor:
Information provided by:
Dynogen Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00215566
First received: September 19, 2005
Last updated: May 25, 2007
Last verified: March 2006
  Purpose

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.


Condition Intervention Phase
Irritable Bowel Syndrome With Constipation
Irritable Bowel Syndrome
Drug: DDP733
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Dynogen Pharmaceuticals:

Primary Outcome Measures:
  • Evaluation of the effect of DDP733 on gastrointestinal transit

Secondary Outcome Measures:
  • Evaluation of the effect of DDP733 on patient reported outcomes

Estimated Enrollment: 90
Study Start Date: September 2005
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00215566

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

No publications provided

ClinicalTrials.gov Identifier: NCT00215566     History of Changes
Other Study ID Numbers: DDP733-04-007
Study First Received: September 19, 2005
Last Updated: May 25, 2007
Health Authority: Canada: Health Canada

Keywords provided by Dynogen Pharmaceuticals:
IBS
IBS-c

Additional relevant MeSH terms:
Constipation
Irritable Bowel Syndrome
Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 29, 2014