A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of DDP733 for IBS-c
NCT ID: NCT00215566
Last Updated: 2007-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2005-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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DDP733
Eligibility Criteria
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Inclusion 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Dynogen Pharmaceuticals
INDUSTRY
Principal Investigators
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William Paterson, MD
Role: STUDY_CHAIR
Hotel Dieu Hospital
Locations
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Hys Medical Centre
Edmonton, Alberta, Canada
St Paul's Hospital
Vancouver, British Columbia, Canada
West Vancouver, British Columbia, Canada
QE II Health Sciences Centre
Halifax, Nova Scotia, Canada
Surrey GI Clinic
Guelph, Ontario, Canada
McMaster University Medical Centre
Hamilton, Ontario, Canada
St. Joseph's Healthcare
Hamilton, Ontario, Canada
Hotel Dieu Hospital
Kingston, Ontario, Canada
St. Joseph's Healthcare
London, Ontario, Canada
Meadowlands Family Health Centre
Ottawa, Ontario, Canada
London Road Diagnostic Clinic
Sarnia, Ontario, Canada
Sarnia Institute of Clinical Research
Sarnia, Ontario, Canada
Canadian Phase Onward Inc.
Toronto, Ontario, Canada
Toronto Digestive Disease Associates, Inc
Toronto, Ontario, Canada
Hopital St-Sacrement
Québec, Quebec, Canada
Countries
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Other Identifiers
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DDP733-04-007
Identifier Type: -
Identifier Source: org_study_id