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| Sponsor: | University of Pennsylvania |
|---|---|
| Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Shire Development LLC |
| Information provided by: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00652145 |
Purpose
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 |
|---|---|---|
|
Ulcerative Colitis |
Drug: mesalamine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Test Treat Strategy to Prevent Ulcerative Colitis Relapse |
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Increase dose of mesalamine by 2.4 gm per day
|
Drug: mesalamine
Increase dose by 2.4gm per day over baseline dose
Other Name: Lialda
|
|
No Intervention: 2
Maintain current mesalamine dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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, Florida | |
| Gastroenterology Group of Naples | Recruiting |
| Naples, Florida, United States, 34102 | |
| Contact: Rose Furgal 239-649-1336 rfurgalresearch@embarqmail.com | |
| Principal Investigator: Raymond Phillips, MD | |
| Shafran Gastroenterology Center | Recruiting |
| Winter Park, Florida, United States, 32789 | |
| Contact: Renee DePanicis, RN 407-629-8121 rmdm74@yahoo.com | |
| Contact: Peggy Galvis, RN 407-629-8121 paggal7@aol.com | |
| Principal Investigator: Ira Shafran, MD | |
| United States, Georgia | |
| Atlanta Gastroenterology Associates | Recruiting |
| Atlanta, Georgia, United States, 30342 | |
| Contact: Erica Brown 404-257-9000 ext 2141 erica.brown@atlantagastro.com | |
| Principal Investigator: Doug Wolf, MD | |
| United States, Maryland | |
| University of Maryland Medical Center | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Ketan Patil 410-706-3387 kpatil@medicine.umaryland.edu | |
| Principal Investigator: Raymond Cross, MD | |
| Chevy Chase Clinical Research | Recruiting |
| Chevy Chase, Maryland, United States, 20815 | |
| Contact: Marissa Mallick 301-652-5520 Marissa.mallek@capitaldigestivecare.com | |
| Principal Investigator: Robert Hardi, MD | |
| United States, Minnesota | |
| Minnesota Gastroenterology, P.A. | Recruiting |
| Plymouth, Minnesota, United States, 55446 | |
| Contact: Britt Oraskovich, CRC 612-870-5896 boraskovich@mngastro.com | |
| Principal Investigator: Robert P McCabe, MD | |
| United States, New Jersey | |
| South Jersey Gastroenterology | Recruiting |
| Marlton, New Jersey, United States, 08053 | |
| Contact: Jamie Jay Rothstein, RN 856-552-3618 jjrsjgiresearch@aol.com | |
| Principal Investigator: Stephen Liakos, DO | |
| United States, Pennsylvania | |
| University of Pennsylvania - Presbyterian Medical Center | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Erin Gilroy 215-746-4218 egilroy@mail.med.upenn.edu | |
| Principal Investigator: James D Lewis, MD, MSCE | |
| Principal Investigator: | James D Lewis, MD, MSCE | University of Pennsylvania |
More Information
| Responsible Party: | James D. Lewis, MD, MSCE, University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00652145 History of Changes |
| Other Study ID Numbers: | K24 DK78228, K24DK078228 |
| Study First Received: | April 1, 2008 |
| Last Updated: | December 2, 2011 |
| Health Authority: | United States: Federal Government |
|
ulcerative colitis inflammatory bowel disease |
|
Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Intestinal Diseases Inflammatory Bowel Diseases Pathologic Processes Mesalamine |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Central Nervous System Agents |