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The Colitis Once Daily Asacol Study (CODA)

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
mesalazine (Asacol®)
Sponsored by
Cardiff and Vale University Health Board
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring IBD, Colitis, UC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barnsley District General Hospital
  • North Hampshire Hospital
  • Birmingham Heartlands Hospital
  • Selly Oak Hospital
  • Bishop Auckland General Hospital
  • Blackpool Victoria Hospital
  • Glan Clwyd Hospital
  • Pilgrim Hospital
  • Princess Royal Hospital
  • Royal Sussex County Hospital
  • Bristol Royal Infirmary
  • Llandough Hospital
  • University Hospital of Wales
  • Cumberland Infirmary
  • Walsgrave Hospital
  • Derby City General Hospital
  • Dr M Al-Najjar
  • Russells Hall Hospital
  • University Hospital of North Durham
  • Stobhill Hospital
  • Gloucester Royal Hospital
  • University Hospital of Hartlepool
  • Hull Royal Infirmary
  • Royal Glamorgan Hospital
  • County Hospital
  • Luton & Dunstable Hospital
  • Macclesfield District General Hospital
  • Borders General Hospital
  • Prince Charles Hospital
  • Norfolk and Norwich University Hospitals NHS Foundation Trust
  • Derriford Hospital
  • Poole General Hospital
  • Queen Alexandra Hospital
  • Royal Berkshire Hospital
  • Rotherham District General Hospital
  • Royal Hallamshire Hospital
  • University Hospital of North Tees & University Hospital of Hartlepool
  • Royal Cornwall Hospital
  • Queen Elizabeth II Hospital
  • New Cross Hospital
  • Alexandra Hospital
  • Worcester Royal Infirmary
  • Worthing Hospital
  • Yeovil District Hospital
  • York District Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1: once daily

2: tds

Arm Description

Three 800mg tablets of mesalazine (Asacol®) in the morning

Mesalazine (Asacol®) 800mg given three times daily

Outcomes

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.

Secondary Outcome Measures

To assess equivalence in terms of safety
To assess equivalence in terms of time to relapse
To assess equivalence in terms of progression of disease (measured by Mayo score)

Full Information

First Posted
April 8, 2008
Last Updated
January 28, 2020
Sponsor
Cardiff and Vale University Health Board
Collaborators
Procter and Gamble
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1. Study Identification

Unique Protocol Identification Number
NCT00708656
Brief Title
The Colitis Once Daily Asacol Study
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardiff and Vale University Health Board
Collaborators
Procter and Gamble

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
IBD, Colitis, UC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
213 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1: once daily
Arm Type
Experimental
Arm Description
Three 800mg tablets of mesalazine (Asacol®) in the morning
Arm Title
2: tds
Arm Type
Active Comparator
Arm Description
Mesalazine (Asacol®) 800mg given three times daily
Intervention Type
Drug
Intervention Name(s)
mesalazine (Asacol®)
Other Intervention Name(s)
Mesalazine, Asacol
Intervention Description
800 mg tablets
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To assess equivalence in terms of safety
Time Frame
12 months
Title
To assess equivalence in terms of time to relapse
Time Frame
12 months
Title
To assess equivalence in terms of progression of disease (measured by Mayo score)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr A B Hawthorne
Organizational Affiliation
Cardiff and Vale University Health Board
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Professor C Probert
Organizational Affiliation
Bristol Royal Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnsley District General Hospital
City
Barnsley
Country
United Kingdom
Facility Name
North Hampshire Hospital
City
Basingstoke
Country
United Kingdom
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
Country
United Kingdom
Facility Name
Selly Oak Hospital
City
Birmingham
Country
United Kingdom
Facility Name
Bishop Auckland General Hospital
City
Bishop Auckland
Country
United Kingdom
Facility Name
Blackpool Victoria Hospital
City
Blackpool
Country
United Kingdom
Facility Name
Glan Clwyd Hospital
City
Bodelwyddan
Country
United Kingdom
Facility Name
Pilgrim Hospital
City
Boston
Country
United Kingdom
Facility Name
Princess Royal Hospital
City
Brighton
Country
United Kingdom
Facility Name
Royal Sussex County Hospital
City
Brighton
Country
United Kingdom
Facility Name
Bristol Royal Infirmary
City
Bristol
Country
United Kingdom
Facility Name
Llandough Hospital
City
Cardiff
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
Country
United Kingdom
Facility Name
Cumberland Infirmary
City
Carlisle
Country
United Kingdom
Facility Name
Walsgrave Hospital
City
Coventry
Country
United Kingdom
Facility Name
Derby City General Hospital
City
Derby
Country
United Kingdom
Facility Name
Dr M Al-Najjar
City
Doncaster
Country
United Kingdom
Facility Name
Russells Hall Hospital
City
Dudley
Country
United Kingdom
Facility Name
University Hospital of North Durham
City
Durham
Country
United Kingdom
Facility Name
Stobhill Hospital
City
Glasgow
Country
United Kingdom
Facility Name
Gloucester Royal Hospital
City
Gloucester
Country
United Kingdom
Facility Name
University Hospital of Hartlepool
City
Hartlepool
Country
United Kingdom
Facility Name
Hull Royal Infirmary
City
Hull
Country
United Kingdom
Facility Name
Royal Glamorgan Hospital
City
Llantrisant
Country
United Kingdom
Facility Name
County Hospital
City
Louth
Country
United Kingdom
Facility Name
Luton & Dunstable Hospital
City
Luton
Country
United Kingdom
Facility Name
Macclesfield District General Hospital
City
Macclesfield
Country
United Kingdom
Facility Name
Borders General Hospital
City
Melrose
Country
United Kingdom
Facility Name
Prince Charles Hospital
City
Merthyr Tydfil
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospitals NHS Foundation Trust
City
Norwich
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
Country
United Kingdom
Facility Name
Poole General Hospital
City
Poole
Country
United Kingdom
Facility Name
Queen Alexandra Hospital
City
Portsmouth
Country
United Kingdom
Facility Name
Royal Berkshire Hospital
City
Reading
Country
United Kingdom
Facility Name
Rotherham District General Hospital
City
Rotherham
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
Country
United Kingdom
Facility Name
University Hospital of North Tees & University Hospital of Hartlepool
City
Stockton on Tees
Country
United Kingdom
Facility Name
Royal Cornwall Hospital
City
Truro
Country
United Kingdom
Facility Name
Queen Elizabeth II Hospital
City
Welwyn Garden City
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
Country
United Kingdom
Facility Name
Alexandra Hospital
City
Worcester
Country
United Kingdom
Facility Name
Worcester Royal Infirmary
City
Worcester
Country
United Kingdom
Facility Name
Worthing Hospital
City
Worthing
Country
United Kingdom
Facility Name
Yeovil District Hospital
City
Yeovil
Country
United Kingdom
Facility Name
York District Hospital
City
York
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28274254
Citation
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.
Results Reference
derived

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The Colitis Once Daily Asacol Study

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