Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain.
Conditions
Interventions
Product Name: mesalazine
Pharmaceutical Form: Tablet
INN or Proposed INN: Mesalazine
CAS Number: 89-57-6
Other descriptive name: 5-Amino
Sponsors
Cardiff and Vale NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet the following criteria will be eligible for study entry: i. 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) ii. 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 enrolment), or • using acceptable contraception (e.g., oral, intramuscular, or implanted hormonal contraception) at least 3 months prior to enrolment, 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) iii. 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 iv. Patients taking mesalazine, sulfasalazine or other drug containing 5-ASA for 4 weeks or longer v. Patients capable of giving written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The following patients will be excluded from the study: i. Patients with Crohn’s disease. ii. Patients with symptoms of active colitis iii. Modified Baron sigmoidoscopy score of 2 or 3 iv. 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. v. 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). vi. Patients with intolerance to Asacol 400 mg or mesalazine. vii. Women who are pregnant or lactating. viii. Patients with known HIV infection. ix. Patients with hepatic disease x. Patients with renal impairment (creatinine above local reference range), or with positive urine dipstick test to blood or protein xi. Other serious medical or psychiatric illness that in the opinion of the investigator would possibly comprise the study. xii. Patients with problem alcohol excess or drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.; Secondary Objective: 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 terms of: • Safety • Time to relapse • Progression of disease (measured by Mayo scoring system) To assess whether a once daily dose of three 800mg tablets of mesalazine (Asacol®) in the morning is superior to mesalazine (Asacol®) given as 800mg three times daily in terms of: • Medication compliance ; Primary end point(s): Relapse rate over 1 year in the intention to treat population, with the study powered to detect non-inferiority of the once-daily regimen vs. the three times daily regimen. Relapse will be defined as: A. Typical symptoms with grade 2-3 mucosal changes (modified Baron score) or B. If sigmoidoscopy is not possible, then any additional medication (enema, suppository, oral or intravenous steroids, enema or suppository mesalazine, or increased dose of oral mesalazine), confirmed by the investigator to be for the treatment of active ulcerative colitis) The time of relapse will be defined as the earlier of either: a) the sigmoidoscopy showing grade 2-3 mucosal changes or b) the date of commencing treatment for active colitis. | — |
Countries
United Kingdom
Outcome results
None listed