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Sponsors and Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Shire Pharmaceutical Development |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00652145 |
The proposed study will test whether increasing Lialda dose can reduce fecal calprotectin (FCP) levels, a marker of intestinal inflammation that is highly predictive of the risk of relapse among patients with quiescent ulcerative colitis. Sixty patients with FCP levels <50mcg/gm stool will be observed for 48 weeks. All patients will have FCP concentration measured using a commercially available assay at enrollment, 6 weeks and 12 weeks. All patients with persistently elevated FCP will receive one or both of the following interventions: change in the mesalamine formulation to Lialda and/or increase in the dose of Lialda. Reduction in FCP levels below 50mcg/gm stool 6 weeks after randomization will be the primary outcome. The proportion of patients achieving this outcome will be compared between groups using Fisher's exact test. All randomized patients as well as those who were excluded from the randomized trial because of a low FCP concentration at baseline will be followed to week 48 to determine the rate of clinical relapse.
Condition | Intervention | Phase |
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Ulcerative Colitis |
Drug: mesalamine |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Test Treat Strategy to Prevent Ulcerative Colitis Relapse |
Estimated Enrollment: | 60 |
Study Start Date: | September 2008 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Increase dose of mesalamine by 2.4 gm per day
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Drug: mesalamine
Increase dose by 2.4gm per day over baseline dose
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2: No Intervention
Maintain current mesalamine dose
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lisa C Nessel, MSS, MLSP | 215-573-6003 | nessel@mail.med.upenn.edu |
Contact: James D Lewis, MD, MSCE | 215-573-5137 | lewisjd@mail.med.upenn.edu |
United States, Georgia | |
Atlanta Gastroenterology Associates | Recruiting |
Atlanta, Georgia, United States, 30342 | |
Contact: Nina McGrew, BSN, RN 404-236-2371 nina.mcgrew@atlantagastro.com | |
Principal Investigator: Doug Wolf, MD | |
United States, Maryland | |
University of Maryland Medical Center | Recruiting |
Baltimore, Maryland, United States, 21201 | |
Contact: Lee Ann Pazulski 410-706-4310 lpazulsk@medicine.umaryland.edu | |
Principal Investigator: Raymond Cross, MD | |
United States, Pennsylvania | |
University of Pennsylvania - Presbyterian Medical Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Ron Berkowsky, BA 215-662-8937 ronald.berkowsky@uphs.upenn.edu | |
Principal Investigator: James D Lewis, MD, MSCE |
Principal Investigator: | James D Lewis, MD, MSCE | University of Pennsylvania |
Responsible Party: | University of Pennsylvania ( James D. Lewis, MD, MSCE ) |
Study ID Numbers: | DK78228 |
Study First Received: | April 1, 2008 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00652145 |
Health Authority: | United States: Federal Government |
ulcerative colitis inflammatory bowel disease |
Digestive System Diseases Mesalamine Gastrointestinal Diseases Ulcer Colonic Diseases |
Inflammatory Bowel Diseases Colitis, Ulcerative Gastroenteritis Intestinal Diseases Colitis |
Anti-Inflammatory Agents Pathologic Processes Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs |
Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents Pharmacologic Actions |