View Clinical Trial (Medical Research Study)
Two Doses Mesalazine Granules Versus Placebo for the Prevention of Recurrence of Diverticulitis - NCT01038739-32168(Clinical Trial 616812)
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| City: |
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New Smyrna Beach |
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State:
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FL |
| Zip Code: |
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32168 |
| Conditions: |
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Diverticulitis |
| Purpose: |
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The purpose of the study is to determine which dose of mesalazine granules compared to
placebo is more effective in the prevention of recurrence of disease.
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| Study summary: |
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The primary purpose of the study is to demonstrate the superiority of mesalazine granules
compared to placebo in terms of the two primary efficacy variables 'proportion of
recurrence-free patients within 48 weeks' and 'proportion of recurrence-free patients within
96 weeks'. |
| Criteria: |
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Inclusion Criteria:
- Diagnosis of left-sided uncomplicated diverticular disease confirmed by computed
tomography
- Presence of at least one diverticulum of the left colon
- Most recent attack of left-sided uncomplicated diverticulitis responding to
antibiotics and/or dietary modification within the last 6 months
- C-reactive protein (CRP) > upper limit of normal (ULN) or leucocytosis at the start
of the most recent attack
Exclusion Criteria:
- Complicated diverticular disease
- Right-sided diverticulitis
- Previous colonic surgery
- Presence of symptomatic organic disease of the gastrointestinal tract
- Active colorectal cancer or a history of colorectal cancer
- Hemorrhagic diathesis
- Active peptic ulcer disease, local intestinal infection
- Asthma if careful medical monitoring is not ensured
- Abnormal hepatic function or liver cirrhosis
- Abnormal renal function |
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| Study is available at: |
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United Medical Research
New Smyrna Beach, FL 32168
United States
Primary Contact:
Ralf Mohrbacher, MSc
Email: mohrbacher@drfalkpharma.de
Phone: +49-761-1514 |
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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 23, 2011 |
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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