The Colitis Once Daily Asacol Study
- Registration Number
- NCT00708656
- Lead Sponsor
- Cardiff and Vale University Health Board
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 213
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2: tds mesalazine (Asacol®) Mesalazine (Asacol®) 800mg given three times daily 1: once daily mesalazine (Asacol®) Three 800mg tablets of mesalazine (Asacol®) in the morning
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (45)
Royal Hallamshire Hospital
🇬🇧Sheffield, United Kingdom
Luton & Dunstable Hospital
🇬🇧Luton, United Kingdom
Borders General Hospital
🇬🇧Melrose, United Kingdom
University Hospital of North Tees & University Hospital of Hartlepool
🇬🇧Stockton on Tees, United Kingdom
Royal Glamorgan Hospital
🇬🇧Llantrisant, United Kingdom
County Hospital
🇬🇧Louth, United Kingdom
Macclesfield District General Hospital
🇬🇧Macclesfield, United Kingdom
Prince Charles Hospital
🇬🇧Merthyr Tydfil, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
🇬🇧Norwich, United Kingdom
Poole General Hospital
🇬🇧Poole, United Kingdom
Queen Alexandra Hospital
🇬🇧Portsmouth, United Kingdom
Royal Berkshire Hospital
🇬🇧Reading, United Kingdom
Worcester Royal Infirmary
🇬🇧Worcester, United Kingdom
Royal Cornwall Hospital
🇬🇧Truro, United Kingdom
Yeovil District Hospital
🇬🇧Yeovil, United Kingdom
Hull Royal Infirmary
🇬🇧Hull, United Kingdom
Alexandra Hospital
🇬🇧Worcester, United Kingdom
Worthing Hospital
🇬🇧Worthing, United Kingdom
Derriford Hospital
🇬🇧Plymouth, United Kingdom
Rotherham District General Hospital
🇬🇧Rotherham, United Kingdom
Queen Elizabeth II Hospital
🇬🇧Welwyn Garden City, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, United Kingdom
York District Hospital
🇬🇧York, United Kingdom
North Hampshire Hospital
🇬🇧Basingstoke, United Kingdom
Birmingham Heartlands Hospital
🇬🇧Birmingham, United Kingdom
Selly Oak Hospital
🇬🇧Birmingham, United Kingdom
Barnsley District General Hospital
🇬🇧Barnsley, United Kingdom
Bishop Auckland General Hospital
🇬🇧Bishop Auckland, United Kingdom
Blackpool Victoria Hospital
🇬🇧Blackpool, United Kingdom
Bristol Royal Infirmary
🇬🇧Bristol, United Kingdom
Glan Clwyd Hospital
🇬🇧Bodelwyddan, United Kingdom
Pilgrim Hospital
🇬🇧Boston, United Kingdom
Walsgrave Hospital
🇬🇧Coventry, United Kingdom
Princess Royal Hospital
🇬🇧Brighton, United Kingdom
Royal Sussex County Hospital
🇬🇧Brighton, United Kingdom
Llandough Hospital
🇬🇧Cardiff, United Kingdom
University Hospital of Wales
🇬🇧Cardiff, United Kingdom
Cumberland Infirmary
🇬🇧Carlisle, United Kingdom
Derby City General Hospital
🇬🇧Derby, United Kingdom
Dr M Al-Najjar
🇬🇧Doncaster, United Kingdom
Russells Hall Hospital
🇬🇧Dudley, United Kingdom
University Hospital of North Durham
🇬🇧Durham, United Kingdom
Stobhill Hospital
🇬🇧Glasgow, United Kingdom
Gloucester Royal Hospital
🇬🇧Gloucester, United Kingdom
University Hospital of Hartlepool
🇬🇧Hartlepool, United Kingdom