A Study of the Safety and Effectiveness of DDP733 in Treating IBS With Constipation in Females - NCT00547469-33155 (Clinical Trial 188314)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy188314.aspx
|
** Please review additional "Nearby Studies" on right ----->
|
|
 |
 |
|
| City: |
|
Miami |
|
State:
|
|
FL |
| Zip Code: |
|
33155 |
| Conditions: |
|
Irritable Bowel Syndrome |
| Purpose: |
|
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.
|
| Study summary: |
|
|
| Criteria: |
|
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 |
|
|
|
| Study is available at: |
|
AppleMed Research Inc.
Miami, FL 33155
United States
Primary Contact:
Carlos Manzano
Email: c26applemed@aol.com
Phone: 305-667-8434 |
|
|
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.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 15, 2010 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|