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CODA: The Colitis Once Daily Asacol Study

Sponsor
Cardiff and Vale University Health Board (Other)
Overall Status
Completed
CT.gov ID
NCT00708656
Collaborator
Procter and Gamble (Industry)
213
Enrollment
45
Locations
2
Arms
47
Duration (Months)
4.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: mesalazine (Asacol®)
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
213 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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.
Study Start Date :
Oct 1, 2006
Actual Primary Completion Date :
Jul 1, 2010
Actual Study Completion Date :
Sep 1, 2010

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    1. To assess equivalence in terms of safety [12 months]

    2. To assess equivalence in terms of time to relapse [12 months]

    3. To assess equivalence in terms of progression of disease (measured by Mayo score) [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Barnsley District General Hospital Barnsley United Kingdom
    2 North Hampshire Hospital Basingstoke United Kingdom
    3 Birmingham Heartlands Hospital Birmingham United Kingdom
    4 Selly Oak Hospital Birmingham United Kingdom
    5 Bishop Auckland General Hospital Bishop Auckland United Kingdom
    6 Blackpool Victoria Hospital Blackpool United Kingdom
    7 Glan Clwyd Hospital Bodelwyddan United Kingdom
    8 Pilgrim Hospital Boston United Kingdom
    9 Princess Royal Hospital Brighton United Kingdom
    10 Royal Sussex County Hospital Brighton United Kingdom
    11 Bristol Royal Infirmary Bristol United Kingdom
    12 Llandough Hospital Cardiff United Kingdom
    13 University Hospital of Wales Cardiff United Kingdom
    14 Cumberland Infirmary Carlisle United Kingdom
    15 Walsgrave Hospital Coventry United Kingdom
    16 Derby City General Hospital Derby United Kingdom
    17 Dr M Al-Najjar Doncaster United Kingdom
    18 Russells Hall Hospital Dudley United Kingdom
    19 University Hospital of North Durham Durham United Kingdom
    20 Stobhill Hospital Glasgow United Kingdom
    21 Gloucester Royal Hospital Gloucester United Kingdom
    22 University Hospital of Hartlepool Hartlepool United Kingdom
    23 Hull Royal Infirmary Hull United Kingdom
    24 Royal Glamorgan Hospital Llantrisant United Kingdom
    25 County Hospital Louth United Kingdom
    26 Luton & Dunstable Hospital Luton United Kingdom
    27 Macclesfield District General Hospital Macclesfield United Kingdom
    28 Borders General Hospital Melrose United Kingdom
    29 Prince Charles Hospital Merthyr Tydfil United Kingdom
    30 Norfolk and Norwich University Hospitals NHS Foundation Trust Norwich United Kingdom
    31 Derriford Hospital Plymouth United Kingdom
    32 Poole General Hospital Poole United Kingdom
    33 Queen Alexandra Hospital Portsmouth United Kingdom
    34 Royal Berkshire Hospital Reading United Kingdom
    35 Rotherham District General Hospital Rotherham United Kingdom
    36 Royal Hallamshire Hospital Sheffield United Kingdom
    37 University Hospital of North Tees & University Hospital of Hartlepool Stockton on Tees United Kingdom
    38 Royal Cornwall Hospital Truro United Kingdom
    39 Queen Elizabeth II Hospital Welwyn Garden City United Kingdom
    40 New Cross Hospital Wolverhampton United Kingdom
    41 Alexandra Hospital Worcester United Kingdom
    42 Worcester Royal Infirmary Worcester United Kingdom
    43 Worthing Hospital Worthing United Kingdom
    44 Yeovil District Hospital Yeovil United Kingdom
    45 York District Hospital York United Kingdom

    Sponsors and Collaborators

    • Cardiff and Vale University Health Board
    • Procter and Gamble

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cardiff and Vale University Health Board
    ClinicalTrials.gov Identifier:
    NCT00708656
    Other Study ID Numbers:
    • HAW0105
    • ISRCTN:35600632
    • EudraCT Number:2005-002784-91
    First Posted:
    Jul 2, 2008
    Last Update Posted:
    Jan 30, 2020
    Last Verified:
    Sep 1, 2010
    Keywords provided by Cardiff and Vale University Health Board
    IBD
    Colitis
    UC
    Additional relevant MeSH terms:
    Colitis
    Colitis, Ulcerative
    Ulcer
    Mesalamine

    Study Results

    No Results Posted as of Jan 30, 2020