The Colitis Once Daily Asacol Study (CODA)

This study has been completed.
Sponsor:
Collaborator:
Procter and Gamble
Information provided by:
Cardiff and Vale University Health Board
ClinicalTrials.gov Identifier:
NCT00708656
First received: April 8, 2008
Last updated: September 16, 2010
Last verified: September 2010
  Purpose

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 Intervention Phase
Ulcerative Colitis
Drug: mesalazine (Asacol®)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:


Further study details as provided by Cardiff and Vale University Health Board:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess equivalence in terms of safety [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To assess equivalence in terms of time to relapse [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To assess equivalence in terms of progression of disease (measured by Mayo score) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 213
Study Start Date: October 2006
Study Completion Date: September 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708656

Locations
United Kingdom
Barnsley District General Hospital
Barnsley, United Kingdom
Selly Oak Hospital
Birmingham, United Kingdom
Birmingham Heartlands 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
Royal Sussex County Hospital
Brighton, United Kingdom
Princess Royal 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
Royal Cornwall Hospital
Cornwall, 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
North Hampshire Hospital
Hampshire, 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
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
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
  More Information

No publications provided

Responsible Party: Dr AB Hawthorne, Cardiff and Vale NHS Trust
ClinicalTrials.gov Identifier: NCT00708656     History of Changes
Other Study ID Numbers: HAW0105, ISRCTN:35600632, EudraCT Number:2005-002784-91
Study First Received: April 8, 2008
Last Updated: September 16, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by Cardiff and Vale University Health Board:
IBD
Colitis
UC

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 24, 2014