Overview

The Colitis Once Daily Asacol Study

Status:
Completed
Trial end date:
2010-09-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare the safety and effectiveness of dosing mesalazine 800 mg tablets (AsacolĀ®) at 2.4 g once daily versus divided doses three times daily in the maintenance of remission of ulcerative colitis.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cardiff and Vale University Health Board
Collaborator:
Procter and Gamble
Treatments:
Mesalamine
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