A Study of the Safety and Effectiveness of DDP733 in Treating IBS With Constipation in Females - NCT00547469-27103 (Clinical Trial 188340)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy188340.aspx
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| City: |
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Winston-Salem |
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State:
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NC |
| Zip Code: |
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27103 |
| Conditions: |
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Irritable Bowel Syndrome |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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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| Study is available at: |
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Piedmont Medical Research Associates
Winston-Salem, NC 27103
United States
Primary Contact:
Margery Newsome
Email: mnewsome@piedmontmedical.com
Phone: 336-768-8062 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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