The Colitis Once Daily Asacol Study (CODA)

January 28, 2020 updated by: Cardiff and Vale University Health Board

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

213

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Barnsley, United Kingdom
        • Barnsley District General Hospital
      • Basingstoke, United Kingdom
        • North Hampshire Hospital
      • Birmingham, United Kingdom
        • Birmingham Heartlands Hospital
      • Birmingham, United Kingdom
        • Selly Oak Hospital
      • Bishop Auckland, United Kingdom
        • Bishop Auckland General Hospital
      • Blackpool, United Kingdom
        • Blackpool Victoria Hospital
      • Bodelwyddan, United Kingdom
        • Glan Clwyd Hospital
      • Boston, United Kingdom
        • Pilgrim Hospital
      • Brighton, United Kingdom
        • Royal Sussex County Hospital
      • Brighton, United Kingdom
        • Princess Royal Hospital
      • Bristol, United Kingdom
        • Bristol Royal Infirmary
      • Cardiff, United Kingdom
        • University Hospital of Wales
      • Cardiff, United Kingdom
        • LLandough Hospital
      • Carlisle, United Kingdom
        • Cumberland Infirmary
      • Coventry, United Kingdom
        • Walsgrave Hospital
      • Derby, United Kingdom
        • Derby City General Hospital
      • Doncaster, United Kingdom
        • Dr M Al-Najjar
      • Dudley, United Kingdom
        • Russells Hall Hospital
      • Durham, United Kingdom
        • University Hospital of North Durham
      • Glasgow, United Kingdom
        • Stobhill Hospital
      • Gloucester, United Kingdom
        • Gloucester Royal Hospital
      • Hartlepool, United Kingdom
        • University Hospital of Hartlepool
      • Hull, United Kingdom
        • Hull Royal Infirmary
      • Llantrisant, United Kingdom
        • Royal Glamorgan Hospital
      • Louth, United Kingdom
        • County Hospital
      • Luton, United Kingdom
        • Luton & Dunstable Hospital
      • Macclesfield, United Kingdom
        • Macclesfield District General Hospital
      • Melrose, United Kingdom
        • Borders General Hospital
      • Merthyr Tydfil, United Kingdom
        • Prince Charles Hospital
      • Norwich, United Kingdom
        • Norfolk and Norwich University Hospitals NHS Foundation Trust
      • Plymouth, United Kingdom
        • Derriford Hospital
      • Poole, United Kingdom
        • Poole General Hospital
      • Portsmouth, United Kingdom
        • Queen Alexandra Hospital
      • Reading, United Kingdom
        • Royal Berkshire Hospital
      • Rotherham, United Kingdom
        • Rotherham District General Hospital
      • Sheffield, United Kingdom
        • Royal Hallamshire Hospital
      • Stockton on Tees, United Kingdom
        • University Hospital of North Tees & University Hospital of Hartlepool
      • Truro, United Kingdom
        • Royal Cornwall Hospital
      • Welwyn Garden City, United Kingdom
        • Queen Elizabeth II Hospital
      • Wolverhampton, United Kingdom
        • New Cross Hospital
      • Worcester, United Kingdom
        • Alexandra Hospital
      • Worcester, United Kingdom
        • Worcester Royal Infirmary
      • Worthing, United Kingdom
        • Worthing Hospital
      • Yeovil, United Kingdom
        • Yeovil District Hospital
      • York, United Kingdom
        • York District Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1: once daily
Three 800mg tablets of mesalazine (Asacol®) in the morning
Drug: mesalazine (Asacol®)
800 mg tablets
Other Names:
  • Mesalazine
  • Asacol
Active Comparator: 2: tds
Mesalazine (Asacol®) 800mg given three times daily
Drug: mesalazine (Asacol®)
800 mg tablets
Other Names:
  • Mesalazine
  • Asacol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: At relapse or 12 month follow up
At relapse or 12 month follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess equivalence in terms of safety
Time Frame: 12 months
12 months
To assess equivalence in terms of time to relapse
Time Frame: 12 months
12 months
To assess equivalence in terms of progression of disease (measured by Mayo score)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiff and Vale University Health Board

Collaborators

Procter and Gamble

Investigators

  • Principal Investigator: Dr A B Hawthorne, Cardiff and Vale University Health Board
  • Principal Investigator: Professor C Probert, Bristol Royal Infirmary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

April 8, 2008

First Submitted That Met QC Criteria

July 1, 2008

First Posted (Estimate)

July 2, 2008

Study Record Updates

Last Update Posted (Actual)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 28, 2020

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAW0105
  • ISRCTN:35600632
  • EudraCT Number:2005-002784-91

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ulcerative Colitis

Clinical Trials on mesalazine (Asacol®)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe