Dose Escalation and Remission (DEAR) (DEAR)
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ClinicalTrials.gov Identifier: NCT00652145 |
Recruitment Status :
Completed
First Posted : April 3, 2008
Results First Posted : May 5, 2015
Last Update Posted : May 5, 2015
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Condition or disease | Intervention/treatment | Phase |
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Ulcerative Colitis | Drug: mesalamine | Phase 4 |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 119 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Test Treat Strategy to Prevent Ulcerative Colitis Relapse |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | January 2013 |
Actual Study Completion Date : | January 2013 |

Arm | Intervention/treatment |
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Experimental: Increase mesalamine dose by 2.4g/day
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
Other Name: Lialda |
No Intervention: Maintain mesalmine dose
Maintain current mesalamine dose at 2.4 g/day
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- Fecal Calprotectin Level <50µg/g [ Time Frame: 6 weeks after randomization ]
- Fecal Calprotectin Level <100 µg/g [ Time Frame: at 6 weeks after randomization ]
- Fecal Calprotectin <200 µg/g [ Time Frame: at 6 weeks after randomization ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00652145
United States, Florida | |
Gastroenterology Group of Naples | |
Naples, Florida, United States, 34102 | |
Shafran Gastroenterology Center | |
Winter Park, Florida, United States, 32789 | |
United States, Georgia | |
Atlanta Gastroenterology Associates | |
Atlanta, Georgia, United States, 30342 | |
United States, Maryland | |
University of Maryland Medical Center | |
Baltimore, Maryland, United States, 21201 | |
Chevy Chase Clinical Research | |
Chevy Chase, Maryland, United States, 20815 | |
United States, Minnesota | |
Minnesota Gastroenterology, P.A. | |
Plymouth, Minnesota, United States, 55446 | |
United States, New Jersey | |
South Jersey Gastroenterology | |
Marlton, New Jersey, United States, 08053 | |
United States, Pennsylvania | |
University of Pennsylvania - Presbyterian Medical Center | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | James D Lewis, MD, MSCE | University of Pennsylvania |
Responsible Party: | James Lewis, Professor of Medicine and Epidemiology, University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00652145 |
Other Study ID Numbers: |
K24DK078228 ( U.S. NIH Grant/Contract ) K24DK078228 ( U.S. NIH Grant/Contract ) |
First Posted: | April 3, 2008 Key Record Dates |
Results First Posted: | May 5, 2015 |
Last Update Posted: | May 5, 2015 |
Last Verified: | May 2015 |
ulcerative colitis inflammatory bowel disease |
Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases |
Mesalamine Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents |