Status:
COMPLETED
Dose Escalation and Remission (DEAR)
Lead Sponsor:
James Lewis
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Shire
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 patie...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT00652145
Start Date
September 1 2008
End Date
January 1 2013
Last Update
May 5 2015
Active Locations (8)
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1
Gastroenterology Group of Naples
Naples, Florida, United States, 34102
2
Shafran Gastroenterology Center
Winter Park, Florida, United States, 32789
3
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30342
4
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201