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

Sponsored by:	Dynogen Pharmaceuticals
Information provided by:	Dynogen Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00215566

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 II

MedlinePlus related topics: Constipation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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

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

Locations

Canada
Hopital St-Sacrement
Quebec, Canada, G1S 4L8
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
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5
Canadian Phase Onward Inc.
Toronto, Ontario, Canada, M3H 5S4
St. Joseph's Healthcare
London, Ontario, Canada, N6A 4V2
Toronto Digestive Disease Associates, Inc
Toronto, Ontario, Canada, M3N 2V7
Sarnia Institute of Clinical Research
Sarnia, Ontario, Canada
Surrey GI Clinic
Guelph, Ontario, Canada
London Road Diagnostic Clinic
Sarnia, Ontario, Canada
Meadowlands Family Health Centre
Ottawa, Ontario, Canada
Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L 5G2

Sponsors and Collaborators

Dynogen Pharmaceuticals

Investigators

Study Chair:

William Paterson, MD

Hotel Dieu Hospital

More Information

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

Keywords provided by Dynogen Pharmaceuticals:

IBS
IBS-c

Study placed in the following topic categories:

Signs and Symptoms
Digestive System Diseases
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Colonic Diseases

Irritable Bowel Syndrome
Constipation
Intestinal Diseases
Colonic Diseases, Functional

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 14, 2009