Ulcerative Colitis
Conditions
Keywords
IBD, Colitis, UC
Brief 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.
Detailed description
Study design * Multicentre, randomized, single-blind, comparator-controlled, parallel-armed study * One year follow-up, or until relapse (whichever shorter) * 40-60 UK centres Subject population * Ulcerative colitis in remission (sigmoidoscopy score of 0 or 1 with no symptoms of active disease, with no treatment for active colitis) for at least 4 weeks, and for no more than 2 years * Taking mesalazine or sulfasalazine prior to study entry * Patients excluded if they have Crohn's disease, symptoms of active colitis, have used corticosteroids, ciclosporin or oral/enema mesalazine in the past 4 weeks, are intolerant to mesalazine or Asacol, are pregnant or lactating, or have known HIV, hepatic disease, renal impairment or other serious medical or psychiatric illness * Sample size 250 * Gender: male or female * Ethnicity: no restriction * Age: over 18 Test Product Once daily group: Asacol® 2.4g daily given as three 800mg tablets orally qAM Three times daily group: Asacol® 2.4g daily given as one 800mg tablet orally three times daily Criteria for Evaluation: Primary Outcome Variable: Relapse rate over 1 year in the intention to treat population, with the study powered to detect non-inferiority of the once-daily regimen. Secondary Outcome Variables: assessment of superiority of the once-daily regimen, if non-inferiority is demonstrated; safety analysis; per protocol analysis of relapse rate; time course of relapse; medication compliance; changes in modified Baron sigmoidoscopy scores between trial entry and relapse/12 month; impact of various factors on relapse rate (time from last relapse at study entry, concomitant azathioprine or 6-mercaptopurine therapy; disease extent; disease duration; smoking status; age at diagnosis; previous dose of mesalazine; baseline calprotectin; baseline CRP level).
Interventions
DRUGmesalazine (Asacol®)
800 mg tablets
Sponsors
Procter and Gamble
Cardiff and Vale University Health Board
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess whether a once daily dose of three 800mg tablets of mesalazine (Asacol®) in the morning is equivalent to mesalazine (Asacol®) given as 800mg three times daily in preventing relapse over a 12 month period. | At relapse or 12 month follow up |
Secondary
| Measure | Time frame |
|---|---|
| To assess equivalence in terms of safety | 12 months |
| To assess equivalence in terms of time to relapse | 12 months |
| To assess equivalence in terms of progression of disease (measured by Mayo score) | 12 months |
Countries
United Kingdom
Outcome results
None listed