8 Weeks Treatment With DDP225 in Patients With Diarrhea Predominant IBS
NCT ID: NCT00230581
Last Updated: 2007-10-15
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
88 participants
INTERVENTIONAL
2005-09-30
2007-08-31
Brief Summary
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Detailed Description
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The total duration of study participation for an individual patient is approximately 10 weeks (74 days) from the initial screening visit to final study evaluations. The total duration of dosing with study medication (either DDP225 or placebo) is 8 weeks.
Patients who satisfy all of the inclusion criteria and none of the exclusion criteria are eligible to enter the Treatment Period and will be randomly assigned to one of four treatment groups.
After a patient is randomized and enters the Treatment Period, she will take the appropriate study medication once a day for 56 days and return to the clinic at two week intervals for a total of four visits during the Treatment Period. During the Treatment Period, patients will maintain a daily diary and complete questionnaires. One week after completing the 56-day Treatment Period, patients return to the clinic for final safety evaluations which include a physical examination, electrocardiogram, and clinical laboratory testing.
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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DDP225
Eligibility Criteria
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Inclusion Criteria
2. History of IBS-d for at least 6 months prior to the initial screening visit.
3. Endoscopic/radiologic bowel evaluation to rule out cancer, obstruction, or other structural disease.
4. The patient must have completed at least six days of assessments in the patient diary in the one week period prior to the second screening visit.
5. Negative serum and urine pregnancy tests and post-partum for at least one year or not breast feeding at the initial screening visit and throughout the study. For patients able to bear children, an acceptable method of birth control must be used throughout the study. Patients unable to bear children must have documentation of such in the case report form (i.e., tubal ligation, hysterectomy, or post-menopausal \[defined as a minimum of one year since the last menstrual period\]).
6. Able to provide voluntary, written informed consent with comprehension of all aspects of the protocol.
Exclusion Criteria
2. Clinically significant abnormal examination findings or laboratory tests
3. Inability to stop taking certain medications, or a planned change in medication (including herbal remedies) which could interfere with study assessments
4. Use of drugs and or ethanol which may interfere with compliance of study procedures or influence study outcome
5. Presence of a medical condition which could interfere with the interpretation of study data
6. Significant use of nicotine or caffeine
18 Years
65 Years
FEMALE
No
Sponsors
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Dynogen Pharmaceuticals
INDUSTRY
Principal Investigators
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William Patterson, MD
Role: STUDY_CHAIR
Hotel Dieu Hospital
Locations
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Radiant Research
Scottsdale, Arizona, United States
Radiant Research
St Louis, Missouri, United States
Long Island Gastrointestinal Research
Great Neck, New York, United States
Radiant Research
Mogadore, Ohio, United States
Radiant Research
Greer, South Carolina, United States
QE II Health Sciences Centre
Halifax, Nova Scotia, 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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DDP225-04-006
Identifier Type: -
Identifier Source: org_study_id