Status:
COMPLETED
The Colitis Once Daily Asacol Study
Lead Sponsor:
Cardiff and Vale University Health Board
Collaborating Sponsors:
Procter and Gamble
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 remi...
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 * ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
213 Patients enrolled
Trial Details
Trial ID
NCT00708656
Start Date
October 1 2006
End Date
September 1 2010
Last Update
January 30 2020
Active Locations (45)
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1
Barnsley District General Hospital
Barnsley, United Kingdom
2
North Hampshire Hospital
Basingstoke, United Kingdom
3
Birmingham Heartlands Hospital
Birmingham, United Kingdom
4
Selly Oak Hospital
Birmingham, United Kingdom