A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of DDP733 for IBS-c
This study has been completed.
Sponsor:
Dynogen Pharmaceuticals
Information provided by:
Dynogen Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00215566
First received: September 19, 2005
Last updated: May 25, 2007
Last verified: March 2006
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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:
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, 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 | |
| McMaster University Medical Centre | |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| St. Joseph's Healthcare | |
| Hamilton, Ontario, Canada, L8N 4A6 | |
| 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 | |
| Toronto Digestive Disease Associates, Inc | |
| Toronto, Ontario, Canada, M3N 2V7 | |
| Canadian Phase Onward Inc. | |
| Toronto, Ontario, Canada, M3H 5S4 | |
| 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 Signs and Symptoms, Digestive Signs and Symptoms Colonic Diseases, Functional |
Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013