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Ulcerative ColitisPhase 3CODANCT00708656

The Colitis Once Daily Asacol Study

A Phase 3 study testing mesalazine (Asacol®) in people with Ulcerative Colitis, run by Cardiff and Vale University Health Board at 45 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis
What is being tested?
mesalazine (Asacol®)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
213 participants
Where
45 sitesUnited Kingdom
Study dates
Oct 2006to Sep 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

45 sites in 1 country.

45 sites in 1 country

United Kingdom45 sites

  • Barnsley District General Hospital

    Barnsley

  • North Hampshire Hospital

    Basingstoke

  • Birmingham Heartlands Hospital

    Birmingham

  • Selly Oak Hospital

    Birmingham

  • Bishop Auckland General Hospital

    Bishop Auckland

  • Blackpool Victoria Hospital

    Blackpool

  • Glan Clwyd Hospital

    Bodelwyddan

  • Pilgrim Hospital

    Boston

  • Princess Royal Hospital

    Brighton

  • Royal Sussex County Hospital

    Brighton

  • Bristol Royal Infirmary

    Bristol

  • Llandough Hospital

    Cardiff

  • University Hospital of Wales

    Cardiff

  • Cumberland Infirmary

    Carlisle

  • Walsgrave Hospital

    Coventry

  • Derby City General Hospital

    Derby

  • Dr M Al-Najjar

    Doncaster

  • Russells Hall Hospital

    Dudley

  • University Hospital of North Durham

    Durham

  • Stobhill Hospital

    Glasgow

  • Gloucester Royal Hospital

    Gloucester

  • University Hospital of Hartlepool

    Hartlepool

  • Hull Royal Infirmary

    Hull

  • Royal Glamorgan Hospital

    Llantrisant

  • County Hospital

    Louth

  • Luton & Dunstable Hospital

    Luton

  • Macclesfield District General Hospital

    Macclesfield

  • Borders General Hospital

    Melrose

  • Prince Charles Hospital

    Merthyr Tydfil

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    Norwich

  • Derriford Hospital

    Plymouth

  • Poole General Hospital

    Poole

  • Queen Alexandra Hospital

    Portsmouth

  • Royal Berkshire Hospital

    Reading

  • Rotherham District General Hospital

    Rotherham

  • Royal Hallamshire Hospital

    Sheffield

  • University Hospital of North Tees & University Hospital of Hartlepool

    Stockton-on-Tees

  • Royal Cornwall Hospital

    Truro

  • Queen Elizabeth II Hospital

    Welwyn Garden City

  • New Cross Hospital

    Wolverhampton

  • Alexandra Hospital

    Worcester

  • Worcester Royal Infirmary

    Worcester

  • Worthing Hospital

    Worthing

  • Yeovil District Hospital

    Yeovil

  • York District Hospital

    York

Other trials in United Kingdom

About this study

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.

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.

Read the 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).

Being tested
mesalazine (Asacol®)
Keywords
IBD, Colitis, UC
Medical subject headings
Colitis, Ulcerative, Colitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mesalazine (Asacol®)Drug

    Also called Mesalazine, Asacol

    800 mg tablets

Study groups in NCT00708656
Study groupRoleWhat they receive
1: once dailyExperimentalThree 800mg tablets of mesalazine (Asacol®) in the morning
Receives: Drug: mesalazine (Asacol®)
2: tdsActive comparatorMesalazine (Asacol®) 800mg given three times daily
Receives: Drug: mesalazine (Asacol®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At relapse or 12 month follow up

Secondary outcomes (3)

  1. To assess equivalence in terms of safety

    Measured: 12 months

  2. To assess equivalence in terms of time to relapse

    Measured: 12 months

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2008 (estimated)
  2. Study startOct 2006
  3. Primary completionJul 2010
  4. Study completionSep 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
213 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00708656
Sponsor's protocol ID
HAW0105
Other IDs
ISRCTN:35600632, EudraCT Number:2005-002784-91
Acronym
CODA
Status last verified
Sep 2010
First submitted
8 Apr 2008
Last updated
30 Jan 2020
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 28274254

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing mesalazine (Asacol®) in people with Ulcerative Colitis, run by Cardiff and Vale University Health Board at 45 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00708656, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2020; AzTrials last refreshed its copy on 27 Oct 2026.

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