- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00652145
Dose Escalation and Remission (DEAR) (DEAR)
Test Treat Strategy to Prevent Ulcerative Colitis Relapse
Study Overview
Detailed Description
Among patients with quiescent ulcerative colitis (UC), lower fecal concentrations of calprotectin are associated with lower rates of relapse. We performed an open-label, randomized controlled trial to investigate whether increasing doses of mesalamine reduce concentrations of fecal calprotectin (FC) in patients with quiescent UC.
We screened 119 patients with UC in remission on the basis of Simple Clinical Colitis Activity Index scores, FC >50 µg/g, and intake of no more than 3 g/day mesalamine. Participants taking mesalamine formulations other than multimatrix mesalamine were switched to multimatrix mesalamine (2.4 g/day) for 6 weeks; 52 participants were then randomly assigned (1:1) to a group that continued its current dose of mesalamine (controls, n = 26) or a group that increased its dose by 2.4 g/day for 6 weeks (n = 26). The primary outcome was continued remission with FC <50 µg/g. Secondary outcomes were continued remission with FC <100 µg/g or <200 µg/g (among patients with pre-randomization values above these levels).
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Florida
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Naples, Florida, United States, 34102
- Gastroenterology Group Of Naples
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Winter Park, Florida, United States, 32789
- Shafran Gastroenterology Center
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Georgia
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Atlanta, Georgia, United States, 30342
- Atlanta Gastroenterology Associates
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland Medical Center
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Chevy Chase, Maryland, United States, 20815
- Chevy Chase Clinical Research
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Minnesota
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Plymouth, Minnesota, United States, 55446
- Minnesota Gastroenterology, P.A.
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New Jersey
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Marlton, New Jersey, United States, 08053
- South Jersey Gastroenterology
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania - Presbyterian Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Understand and sign the informed consent form.
- Have documented ulcerative colitis on the basis of usual diagnostic criteria including clinical symptoms and findings from endoscopy, radiology studies, and histology.
- Have a Simple Clinical Colitis Activity Index (SCCAI)55 score below 3 with no category value greater than 1 (Table 5).
- Three or fewer bowel movements per 24 hours at the time of enrollment.
- No visible blood in their bowel movements in the three days prior to enrollment.
- Have either been on a stable dose of mesalamine medication (oral, rectal or a combination of oral and rectal, including sulfasalazine) or on no mesalamine medications for at least 4 weeks prior to enrollment.
- Have been on either a stable dose of azathioprine, 6-mercaptopurine, or methotrexate or on none of these medications for at least 8 weeks prior to enrollment.
- Have experienced at least one flare of ulcerative colitis in the 2 years prior to enrollment. A flare is defined as an increase in stool frequency, bleeding, urgency and/or abdominal discomfort sufficient to warrant a change in medication dose or addition of a new medication.
- Most recently measured serum creatinine level in the preceding year less than 1.5 mg/dL.
Exclusion Criteria:
- Age less than 18
- Inability to speak and read English
- Presence of an ostomy or prior total or subtotal colectomy
- Current corticosteroid use or use within the two weeks prior to enrollment
- Remission for less than 4 weeks prior to enrollment
- Previous intolerance to mesalamine at doses greater than the current dose.
- Use of rectally administered mesalamine or steroids within the 2 weeks prior to enrollment.
- Currently taking more than 3.0 gm/day of mesalamine (oral or rectal). If on oral and rectal mesalamine, the combined dose is more than 3.0 gm/day.
- Use of anti-TNFα therapies within the 8 weeks prior to enrollment and/or intent to use anti-TNFα therapies as maintenance therapy in the coming 12 weeks.
- Pregnant or breast feeding women.
- Use of an experimental therapy for ulcerative colitis in the 8 weeks prior to enrollment.
- Any condition that the investigator feels will make completion of the study unlikely.
- Use of cyclosporine in the two weeks prior to enrollment.
- Moderate or severe abdominal tenderness on examination at time of enrollment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Increase mesalamine dose by 2.4g/day
Increase dose of mesalamine by 2.4 gm per day
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Increase dose by 2.4gm per day over baseline dose
Other Names:
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NO_INTERVENTION: Maintain mesalmine dose
Maintain current mesalamine dose at 2.4 g/day
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fecal Calprotectin Level <50µg/g
Time Frame: 6 weeks after randomization
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6 weeks after randomization
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fecal Calprotectin Level <100 µg/g
Time Frame: at 6 weeks after randomization
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at 6 weeks after randomization
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Fecal Calprotectin <200 µg/g
Time Frame: at 6 weeks after randomization
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at 6 weeks after randomization
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Gastrointestinal Diseases
- Gastroenteritis
- Colonic Diseases
- Intestinal Diseases
- Inflammatory Bowel Diseases
- Ulcer
- Colitis
- Colitis, Ulcerative
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Mesalamine
Other Study ID Numbers
- K24DK078228 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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