Study Results
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Basic Information
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COMPLETED
PHASE3
213 participants
INTERVENTIONAL
2006-10-31
2010-09-30
Brief Summary
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Detailed Description
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* 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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1: once daily
Three 800mg tablets of mesalazine (Asacol®) in the morning
mesalazine (Asacol®)
800 mg tablets
2: tds
Mesalazine (Asacol®) 800mg given three times daily
mesalazine (Asacol®)
800 mg tablets
Interventions
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mesalazine (Asacol®)
800 mg tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Procter and Gamble
INDUSTRY
Cardiff and Vale University Health Board
OTHER_GOV
Responsible Party
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Principal Investigators
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Dr A B Hawthorne
Role: PRINCIPAL_INVESTIGATOR
Cardiff and Vale University Health Board
Professor C Probert
Role: PRINCIPAL_INVESTIGATOR
Bristol Royal Infirmary
Locations
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Barnsley District General Hospital
Barnsley, , United Kingdom
North Hampshire Hospital
Basingstoke, , United Kingdom
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
Selly Oak Hospital
Birmingham, , United Kingdom
Bishop Auckland General Hospital
Bishop Auckland, , United Kingdom
Blackpool Victoria Hospital
Blackpool, , United Kingdom
Glan Clwyd Hospital
Bodelwyddan, , United Kingdom
Pilgrim Hospital
Boston, , United Kingdom
Princess Royal Hospital
Brighton, , United Kingdom
Royal Sussex County Hospital
Brighton, , United Kingdom
Bristol Royal Infirmary
Bristol, , United Kingdom
Llandough Hospital
Cardiff, , United Kingdom
University Hospital of Wales
Cardiff, , United Kingdom
Cumberland Infirmary
Carlisle, , United Kingdom
Walsgrave Hospital
Coventry, , 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
Hull Royal Infirmary
Hull, , United Kingdom
Royal Glamorgan Hospital
Llantrisant, , United Kingdom
County Hospital
Louth, , United Kingdom
Luton & Dunstable Hospital
Luton, , United Kingdom
Macclesfield District General Hospital
Macclesfield, , United Kingdom
Borders General Hospital
Melrose, , United Kingdom
Prince Charles Hospital
Merthyr Tydfil, , United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Poole General Hospital
Poole, , United Kingdom
Queen Alexandra Hospital
Portsmouth, , United Kingdom
Royal Berkshire Hospital
Reading, , United Kingdom
Rotherham District General Hospital
Rotherham, , United Kingdom
Royal Hallamshire Hospital
Sheffield, , United Kingdom
University Hospital of North Tees & University Hospital of Hartlepool
Stockton-on-Tees, , United Kingdom
Royal Cornwall Hospital
Truro, , United Kingdom
Queen Elizabeth II Hospital
Welwyn Garden City, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Alexandra Hospital
Worcester, , United Kingdom
Worcester Royal Infirmary
Worcester, , United Kingdom
Worthing Hospital
Worthing, , United Kingdom
Yeovil District Hospital
Yeovil, , United Kingdom
York District Hospital
York, , United Kingdom
Countries
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References
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Gillespie D, Farewell D, Barrett-Lee P, Casbard A, Hawthorne AB, Hurt C, Murray N, Probert C, Stenson R, Hood K. The use of randomisation-based efficacy estimators in non-inferiority trials. Trials. 2017 Mar 9;18(1):117. doi: 10.1186/s13063-017-1837-3.
Other Identifiers
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ISRCTN:35600632
Identifier Type: -
Identifier Source: secondary_id
EudraCT Number:2005-002784-91
Identifier Type: -
Identifier Source: secondary_id
HAW0105
Identifier Type: -
Identifier Source: org_study_id
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