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Register:	EUCTR
Last refreshed on:	25 November 2019
Main ID:	EUCTR2005-002784-91-GB
Date of registration:	24/11/2005
Prospective Registration:	Yes
Primary sponsor:	Cardiff and Vale NHS Trust
Public title:	A Randomized, Multicentre, Parallel Group Single-Blind Study to Assess the Efficacy and Safety of Dosing Mesalazine 800 mg Tablets (Asacol®) at 2.4 g Once Daily versus Divided Doses Three Times Daily for 12 Months in the Maintenance of Remission of Ulcerative Colitis. - CODA study (Colitis Once Daily Asacol)
Scientific title:	A Randomized, Multicentre, Parallel Group Single-Blind Study to Assess the Efficacy and Safety of Dosing Mesalazine 800 mg Tablets (Asacol®) at 2.4 g Once Daily versus Divided Doses Three Times Daily for 12 Months in the Maintenance of Remission of Ulcerative Colitis. - CODA study (Colitis Once Daily Asacol)
Date of first enrolment:	06/02/2006
Target sample size:	630
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002784-91
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: same IMP, same dose, but different dose regimen
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment
United Kingdom

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
Patients who meet the following criteria will be eligible for study entry:

i. 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)

ii. 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 enrolment), or
• using acceptable contraception (e.g., oral, intramuscular, or implanted hormonal contraception) at least 3 months prior to enrolment, 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)

iii. 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

iv. Patients taking mesalazine, sulfasalazine or other drug containing 5-ASA for 4 weeks or longer

v. Patients capable of giving written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
The following patients will be excluded from the study:

i. Patients with Crohn’s disease.

ii. Patients with symptoms of active colitis

iii. Modified Baron sigmoidoscopy score of 2 or 3

iv. 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.

v. 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).

vi. Patients with intolerance to Asacol 400 mg or mesalazine.

vii. Women who are pregnant or lactating.

viii. Patients with known HIV infection.

ix. Patients with hepatic disease

x. Patients with renal impairment (creatinine above local reference range), or with positive urine dipstick test to blood or protein

xi. Other serious medical or psychiatric illness that in the opinion of the investigator would possibly comprise the study.

xii. Patients with problem alcohol excess or drug abuse.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain.

Intervention(s)

Product Name: mesalazine
Pharmaceutical Form: Tablet
INN or Proposed INN: Mesalazine
CAS Number: 89-57-6
Other descriptive name: 5-Aminosalicylic Acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 800-

Primary Outcome(s)

Primary end point(s): Relapse rate over 1 year in the intention to treat population, with the study powered to detect non-inferiority of the once-daily regimen vs. the three times daily regimen.

Relapse will be defined as:

A. Typical symptoms with grade 2-3 mucosal changes (modified Baron score) or

B. If sigmoidoscopy is not possible, then any additional medication (enema, suppository, oral or intravenous steroids, enema or suppository mesalazine, or increased dose of oral mesalazine), confirmed by the investigator to be for the treatment of active ulcerative colitis)

The time of relapse will be defined as the earlier of either: a) the sigmoidoscopy showing grade 2-3 mucosal changes or b) the date of commencing treatment for active colitis.

Secondary Objective: 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 terms of:
• Safety
• Time to relapse
• Progression of disease (measured by Mayo scoring system)

To assess whether a once daily dose of three 800mg tablets of mesalazine (Asacol®) in the morning is superior to mesalazine (Asacol®) given as 800mg three times daily in terms of:
• Medication compliance

Main Objective: 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(s)

Secondary ID(s)

HAW0501

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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