A Trial of Rosiglitazone for Ulcerative Colitis

NCT00065065 | Completed Phase 2 Results DMC

• 2 other identifiers: ROSIER01DK059961
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 13

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled study evaluating rosiglitazone: 4 mg tablets or placebo tablets administered orally twice daily for 12 weeks. The purpose of the study is to evaluate the efficacy and safety of rosiglitazone in the treatment of mild to moderately active ulcerative colitis. Disease activity will be measured using a standard disease activity index. Calculation of the index requires patients to undergo flexible sigmoidoscopy at the start of the study and at week 12.

Conditions

Ulcerative Colitis; Inflammatory Bowel Disease

Keywords

Rosiglitazone; Ulcerative; Colitis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Improvement of Signs and Symptoms of UC at 12 Weeks

  Mayo score decrease \>=2 points adjusted for age and smoking status.

  12 weeks

Secondary Outcomes (2)

• Number of Participants With Clinical Remission at 12 Weeks

  12 weeks

• Number of Participants With Endoscopic Remission at 12 Weeks

  12 weeks

Study Arms (2)

Rosiglitazone

EXPERIMENTAL

4 mg of rosiglitazone taken twice daily for 12 weeks.

Drug: Rosiglitazone

placebo

PLACEBO COMPARATOR

Identical in appearance to study drug taken twice daily for 12 weeks.

Drug: Placebo

Interventions

Rosiglitazone DRUG

4mg orally twice daily for 12 weeks

Also known as: Avandia

Rosiglitazone

Placebo DRUG

pill that looks identical to rosiglitazone

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must sign and date the informed consent form
• At least 18 years of age
• Documented diagnosis (endoscopic, surgical or x-ray) of ulcerative colitis (UC)
• Mild to moderate ulcerative colitis indicated by Disease Activity Index score of greater than or equal to 4 and less than or equal to 10
• Unless the patient is intolerant of oral 5-ASA therapy, patient must be treated with a minimum of 2 gm daily of an oral 5-ASA agent for a minimum of 4 weeks during the current exacerbation of ulcerative colitis or immediately prior to study entry
• If treated with oral corticosteroids, dose must not exceed 20 mg per day of Prednisone or equivalent
• If treated with corticosteroids, dose must be stable for 4 weeks prior to study entry and remain on same dose throughout
• If treated with 6-mercaptopurine or azathioprine, must have been on medication for 4 months and a stable dose for 2 months prior to study entry
• If a female of childbearing age, the participant must have a negative serum pregnancy test and have been using a medically approved form of contraceptive birth control for 3 months prior to enrollment. Participants, both male and female, must also be willing to use medically approved contraceptive birth control (at least one barrier method) throughout the study
• If treated with rectal therapy, dose must be stable for 2 weeks prior to study entry and remain on same dose throughout

You may not qualify if:

• Severe ulcerative colitis indicated by Disease Activity Index score of greater than 10
• Class III or IV congestive heart failure by NYHA classification system
• Allergy to thiazolidinediones
• Presence of any medical condition with an expected survival of less than 1 year
• Participants receiving therapy with cyclosporin, anti-TNF therapy, or methotrexate within the last 2 months of screening
• Positive stool culture for enteric pathogens (salmonella, shigella, and campylobacter), positive C.difficile toxin, or positive stool ova and parasite exam
• Positive proteinuria by urine dipstick
• History of chronic liver disease or baseline liver chemistries greater than the upper limit of normal
• Diabetes mellitus requiring hypoglycemic agents
• Participation in study of experimental therapy within 2 months of first screening visit
• Has any of the following laboratory abnormalities: WBC \< 3,000 per uL, Neutrophil \< 1,000 cell/cu.mm, Platelets \<75,000 per uL, INR \> 1.2
• Participant is female and is pregnant or currently breastfeeding

Sponsors & Collaborators

• James Lewis: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• GlaxoSmithKline: collaborator

Study Sites (13)

Atlanta Gastroenterology Associates

Atlanta, Georgia, 30342, United States

Location

University of Chicago Hospitals

Chicago, Illinois, 60637, United States

Location

Metropolitan Gastroenterology Group Practice/Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815, United States

Location

Maryland Digestive Diseases Research

Laurel, Maryland, 20707, United States

Location

Capitol Gastroenterology Consultants

Silver Spring, Maryland, 20901, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Minnesota Gastroenterology

Plymouth, Minnesota, 55446, United States

Location

Atlantic Gastroenterology Associates

Egg Harbor, New Jersey, 08234, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Avamar Center for Endoscopy

Warren, Ohio, 44484, United States

Location

University of Pennsylvania - Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• Lewis JD, Lichtenstein GR, Deren JJ, Sands BE, Hanauer SB, Katz JA, Lashner B, Present DH, Chuai S, Ellenberg JH, Nessel L, Wu GD; Rosiglitazone for Ulcerative Colitis Study Group. Rosiglitazone for active ulcerative colitis: a randomized placebo-controlled trial. Gastroenterology. 2008 Mar;134(3):688-95. doi: 10.1053/j.gastro.2007.12.012. Epub 2007 Dec 7.

  PMID: 18325386 RESULT

• Lewis JD, Chuai S, Nessel L, Lichtenstein GR, Aberra FN, Ellenberg JH. Use of the noninvasive components of the Mayo score to assess clinical response in ulcerative colitis. Inflamm Bowel Dis. 2008 Dec;14(12):1660-6. doi: 10.1002/ibd.20520.

  PMID: 18623174 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases; Ulcer; Colitis

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: James D. Lewis, MD, MSCE
• Organization: University of Pennsylvania

lewisjd@mail.med.upenn.edu

215-573-5137

Study Officials

• James D Lewis, MD, MSCE

  University of Pennsylvania

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine and Epidemiology

Study Record Dates

• First Submitted: July 16, 2003
• First Posted: July 18, 2003
• Study Start: September 1, 2002
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: January 16, 2018
• Results First Posted: December 2, 2014

Record last verified: 2017-12

Locations

US (13)