A Study of the Safety and Effectiveness of DDP733 in Treating IBS With Constipation in Females
Status: | Recruiting |
---|---|
Conditions: | Constipation, Irritable Bowel Syndrome (IBS) |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 4/2/2016 |
Start Date: | October 2007 |
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Effectiveness of DDP733 in Female Patients With Irritable Bowel Syndrome With Constipation
This study will evaluate the safety and effectiveness of the investigational drug DDP733 in
treating female patients with IBS-c. A placebo control will be utilized.
treating female patients with IBS-c. A placebo control will be utilized.
Inclusion Criteria:
- Female from 18 to 65 years of age, inclusive
- Patient experiences recurrent abdominal pain or discomfort at least 3 days per month
for the last 3 months with symptom onset at least 6 months prior to diagnosis. The
patient's symptoms must be associated with 1 or more of the following:
- Improvement with defecation
- Onset associated with a change in frequency of stool
- Onset associated with a change in form (appearance) of stool
- Negative serum and urine pregnancy tests
- Completion of at least six days of daily diary assessments using a phone-in
information system prior to randomization
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
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About Us Accord Clinical Research is a privately owned research facility, founded in Port Orange,...
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135 W. Ravine Road
Kingsport, Tennessee 37660
Kingsport, Tennessee 37660
423-230-3154
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University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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