The Colitis Once Daily Asacol Study

Ulcerative Colitis Clinical Trial

— CODA  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00708656
• Other study ID #: HAW0105
• Secondary ID: ISRCTN:35600632E
• Status: Completed
• Phase: Phase 3
• Start date: October 2006
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• Source: Cardiff and Vale University Health Board
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: September 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• mesalazine (Asacol®)
800 mg tablets

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (2)

Lead Sponsor	Collaborator
Cardiff and Vale University Health Board	Procter and Gamble

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To assess equivalence in terms of safety		12 months
Secondary	To assess equivalence in terms of time to relapse		12 months
Secondary	To assess equivalence in terms of progression of disease (measured by Mayo score)		12 months