Prevention of Recurrence of Diverticulitis - NCT00545103-27612 (Clinical Trial 109288)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy109288.aspx
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| City: |
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Raleigh |
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State:
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NC |
| Zip Code: |
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27612 |
| Conditions: |
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Diverticulitis |
| Purpose: |
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The purpose of this study is to determine whether SPD476 is effective in reducing recurrence
of diverticulitis.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
1. Males and females =>18yrs of age.
2. If female of childbearing potential (FOCP), has demonstrated a negative beta HCG
(human chorionic gonadotropin) serum pregnancy test, and agrees to comply with any
applicable contraceptive requirements of the protocol
3. An episode of acute diverticulitis that resolved without colonic resection.
4. Confirmation of diverticulosis via endoscopic evaluation of the sigmoid colon with at
least three diverticula noted
Exclusion Criteria:
1. Previous colorectal surgery, including surgical intervention for diverticular disease
(with the exception of haemorrhoidectomy, colonic removal of polyps, and
appendectomy)
2. Active peptic ulcer disease
3. History of or current presence of inflammatory bowel disease (IBD)
4. Subjects with active irritable bowel syndrome (IBS) requiring ongoing medication
5. Allergy or hypersensitivity to aspirin or related compounds
6. Allergy to radiologic contrast agents
7. Use of another Investigational product within 30 days of Baseline
8. Use of antibiotic therapy within 4 weeks of Baseline
9. Within 14 days of Baseline, use of prebiotic, probiotic or 5-ASA medications, as well
as drugs active at the 5HT-receptor or anti-spasmodic agents
10. Use of systemic or rectal steroids within 6 weeks of Baseline. Use of inhaled or
nasal steroids is acceptable
11. Use of anti-inflammatory drugs, (NSIADs, COX-2 inhibitors) including aspirin (except
for cardiac prophylaxis) and ibuprofen, on a regular and ongoing basis
12. History of alcohol or other substance abuse within the previous year
13. Active or recent history of endometriosis or dysmenorrhoea within 6 months prior to
Baseline
14. Females who are lactating |
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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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February 16, 2010 |
Modifications to
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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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