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Dose Escalation and Remission (DEAR)
This study is currently recruiting participants.
Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), October 2009
First Received: April 1, 2008   Last Updated: October 5, 2009   History of Changes
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator: Shire Pharmaceutical Development
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 IV

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: Test Treat Strategy to Prevent Ulcerative Colitis Relapse

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Concentration of fecal Calprotection [ 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 ]

Estimated Enrollment: 60
Study Start Date: September 2008
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Increase dose of mesalamine by 2.4 gm per day
Drug: mesalamine
Increase dose by 2.4gm per day over baseline dose
2: No Intervention
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

Contacts
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

Locations
United States, Georgia
Atlanta Gastroenterology Associates Recruiting
Atlanta, Georgia, United States, 30342
Contact: Nina McGrew, BSN, RN     404-236-2371     nina.mcgrew@atlantagastro.com    
Principal Investigator: Doug Wolf, MD            
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Lee Ann Pazulski     410-706-4310     lpazulsk@medicine.umaryland.edu    
Principal Investigator: Raymond Cross, MD            
Chevy Chase Clinical Research Recruiting
Chevy Chase, Maryland, United States, 20815
Contact: Florence Canda     301-652-5520     florence.canda@metrogastro.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     jamieSJGIReseach@hotmail.com    
Principal Investigator: Stephen Liakos, DO            
United States, Pennsylvania
University of Pennsylvania - Presbyterian Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Ron Berkowsky, BA     215-662-8937     ronald.berkowsky@uphs.upenn.edu    
Principal Investigator: James D Lewis, MD, MSCE            
United States, Rhode Island
Gastroenterology Associates Inc Recruiting
Providence, Rhode Island, United States, 02904
Contact: Adina Schreiber     401-274-4800 ext 213     adinaschreiber@hotmail.com    
Principal Investigator: Samire Shah, MD            
Sponsors and Collaborators
Shire Pharmaceutical Development
Investigators
Principal Investigator: James D Lewis, MD, MSCE University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania ( James D. Lewis, MD, MSCE )
Study ID Numbers: DK78228
Study First Received: April 1, 2008
Last Updated: October 5, 2009
ClinicalTrials.gov Identifier: NCT00652145     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
ulcerative colitis
inflammatory bowel disease

Additional relevant MeSH terms:
Mesalamine
Anti-Inflammatory Agents
Gastrointestinal Diseases
Ulcer
Physiological Effects of Drugs
Colonic Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases
Pharmacologic Actions
Digestive System Diseases
Pathologic Processes
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Gastroenteritis
Central Nervous System Agents
Colitis

ClinicalTrials.gov processed this record on November 20, 2009