The Colitis Once Daily Asacol Study

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the safety and effectiveness of dosing mesalazine 800 mg tablets (Asacol®) at 2.4 g once daily versus divided doses three times daily in the maintenance of remission of ulcerative colitis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cardiff and Vale University Health Board
• Collaborator: Procter and Gamble
• Treatments: Mesalamine

Criteria

Inclusion Criteria:

Patients who meet the following criteria will be eligible for study entry:

• Male and female patients aged over 18 with ulcerative colitis confirmed by histology who are in remission (no symptoms of active disease, and modified Baron sigmoidoscopic score of 0 or 1)

• If female, must be (as documented in patient notes):

• postmenopausal (at least 1 year without spontaneous menses), or

• surgically sterile (tubal ligation or hysterectomy at least 6 months prior to enrollment), or

• using acceptable contraception (e.g., oral, intramuscular, or implanted hormonal contraception) at least 3 months prior to enrollment, or

• have a sexual partner with non-reversed vasectomy (with confirmed azoospermia), or

• be using 1 barrier method (e.g., condom, diaphragm, spermicide, or intra-uterine device)

• Patients whose ulcerative colitis has been in clinical remission for 4 weeks or longer, and who have had a symptomatic relapse within the past two years

• Patients taking mesalazine, sulfasalazine or other drug containing 5-ASA for 4 weeks or longer

• Patients capable of giving written informed consent

Exclusion Criteria:

The following patients will be excluded from the study:

• Patients with Crohn's disease

• Patients with symptoms of active colitis

• Modified Baron sigmoidoscopy score of 2 or 3

• Patients who have used oral, enema, intravenous or suppository preparations of corticosteroids, oral or intravenous ciclosporin, mesalazine enemas or suppositories within the past four weeks

• Patients taking azathioprine or 6-mercaptopurine who have altered the dose or started treatment within the past three months, (these drugs permitted in stable dose during the study)

• Patients with intolerance to Asacol 400 mg or mesalazine

• Women who are pregnant or lactating

• Patients with known HIV infection

• Patients with hepatic disease

• Patients with renal impairment (creatinine above local reference range), or with positive urine dipstick test to blood or protein

• Other serious medical or psychiatric illness that in the opinion of the investigator would possibly comprise the study

• Patients with problem alcohol excess or drug abuse