the colitis once daily asacol study

Conditions: Ulcerative Colitis

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.

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).

Eligibility 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

Keywords: ibd colitis uc