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The Colitis Once Daily Asacol Study (CODA)

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ClinicalTrials.gov Identifier: NCT00708656
Recruitment Status : Completed
First Posted : July 2, 2008
Last Update Posted : September 17, 2010
Sponsor:
Collaborator:
Procter and Gamble
Information provided by:
Cardiff and Vale University Health Board

Tracking Information
First Submitted Date  ICMJE April 8, 2008
First Posted Date  ICMJE July 2, 2008
Last Update Posted Date September 17, 2010
Study Start Date  ICMJE October 2006
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00708656 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2008)
  • To assess equivalence in terms of safety [ Time Frame: 12 months ]
  • To assess equivalence in terms of time to relapse [ Time Frame: 12 months ]
  • To assess equivalence in terms of progression of disease (measured by Mayo score) [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Colitis Once Daily Asacol Study
Official Title  ICMJE 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.
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE Drug: mesalazine (Asacol®)
800 mg tablets
Other Names:
  • Mesalazine
  • Asacol
Study Arms  ICMJE
  • Experimental: 1: once daily
    Three 800mg tablets of mesalazine (Asacol®) in the morning
    Intervention: Drug: mesalazine (Asacol®)
  • Active Comparator: 2: tds
    Mesalazine (Asacol®) 800mg given three times daily
    Intervention: Drug: mesalazine (Asacol®)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 16, 2010)
213
Original Estimated Enrollment  ICMJE
 (submitted: July 1, 2008)
250
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00708656
Other Study ID Numbers  ICMJE HAW0105
ISRCTN:35600632
EudraCT Number:2005-002784-91
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr AB Hawthorne, Cardiff and Vale NHS Trust
Study Sponsor  ICMJE Cardiff and Vale University Health Board
Collaborators  ICMJE Procter and Gamble
Investigators  ICMJE
Principal Investigator: Dr A B Hawthorne Cardiff and Vale University Health Board
Principal Investigator: Professor C Probert Bristol Royal Infirmary
PRS Account Cardiff and Vale University Health Board
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP