The Colitis Once Daily Asacol Study
CODA
A Randomized, Single-Blind Study to Assess Efficacy and Safety of Dosing Mesalazine 800 mg Tablets (Asacol®) at 2.4 g Once Daily Versus Divided Doses 3 Times Daily for 12 Months in Maintenance of Remission of Ulcerative Colitis.
3 other identifiers
interventional
213
1 country
45
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2006
Typical duration for phase_3
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 8, 2008
CompletedFirst Posted
Study publicly available on registry
July 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedJanuary 30, 2020
September 1, 2010
3.8 years
April 8, 2008
January 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (2)
1: once daily
EXPERIMENTALThree 800mg tablets of mesalazine (Asacol®) in the morning
2: tds
ACTIVE COMPARATORMesalazine (Asacol®) 800mg given three times daily
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cardiff and Vale University Health Boardlead
- Procter and Gamblecollaborator
Study Sites (45)
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
Related Publications (1)
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.
PMID: 28274254DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr A B Hawthorne
Cardiff and Vale University Health Board
- PRINCIPAL INVESTIGATOR
Professor C Probert
Bristol Royal Infirmary
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2008
First Posted
July 2, 2008
Study Start
October 1, 2006
Primary Completion
July 1, 2010
Study Completion
September 1, 2010
Last Updated
January 30, 2020
Record last verified: 2010-09