Dose Escalation and Remission (DEAR)

This study has been completed.
Sponsor:
Collaborators:
Shire
Information provided by (Responsible Party):
James Lewis, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00652145
First received: April 1, 2008
Last updated: June 27, 2013
Last verified: June 2013
  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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Concentration of fecal Calprotectin [ Time Frame: 6 weeks after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical relapse of ulcerative colitis as measured by the Simple Clinical Colitis Activity Index (SCCAI) [ Time Frame: up to 48 weeks of followup ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: September 2008
Study Completion Date: January 2013
Primary Completion Date: January 2013 (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
Criteria

Inclusion Criteria:

  1. Understand and sign the informed consent form.
  2. Have documented ulcerative colitis on the basis of usual diagnostic criteria including clinical symptoms and findings from endoscopy, radiology studies, and histology.
  3. Have a Simple Clinical Colitis Activity Index (SCCAI)55 score below 3 with no category value greater than 1 (Table 5).
  4. Three or fewer bowel movements per 24 hours at the time of enrollment.
  5. No visible blood in their bowel movements in the three days prior to enrollment.
  6. 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.
  7. 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.
  8. 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.
  9. Most recently measured serum creatinine level in the preceding year less than 1.5 mg/dL.

Exclusion Criteria:

  1. Age less than 18
  2. Inability to speak and read English
  3. Presence of an ostomy or prior total or subtotal colectomy
  4. Current corticosteroid use or use within the two weeks prior to enrollment
  5. Remission for less than 4 weeks prior to enrollment
  6. Previous intolerance to mesalamine at doses greater than the current dose.
  7. Use of rectally administered mesalamine or steroids within the 2 weeks prior to enrollment.
  8. 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.
  9. 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.
  10. Pregnant or breast feeding women.
  11. Use of an experimental therapy for ulcerative colitis in the 8 weeks prior to enrollment.
  12. Any condition that the investigator feels will make completion of the study unlikely.
  13. Use of cyclosporine in the two weeks prior to enrollment.
  14. Moderate or severe abdominal tenderness on examination at time of enrollment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00652145

Locations
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
Sponsors and Collaborators
James Lewis
Shire
Investigators
Principal Investigator: James D Lewis, MD, MSCE University of Pennsylvania
  More Information

No publications provided

Responsible Party: James Lewis, Professor of Medicine and Epidemiology, 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: June 27, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Pennsylvania:
ulcerative colitis
inflammatory bowel disease

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on April 22, 2014