Controlled Assessment of Salicylate and Azathioprine

Completed

• Conditions: lcerative colitis; Digestive System; Ulcerative colitis

• Registration Number: ISRCTN99666810
• Lead Sponsor: niversity of Nottingham (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-30
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 410

Inclusion Criteria

1. Male and female patients aged between 18 and 75 years with ulcerative colitis
2. Patients whose ulcerative colitis has been in clinical remission, defined as being off steroids for 3 months or longer
3. Patients taking both azathioprine (or 6-mercaptopurine) and an aminosalicylate
4. Patients taking azathioprine (greater than 50 mg/day) or 6-mercaptopurine (greater than 25 mg/day) at a stable dose for at least 8 weeks
5. Patients taking an aminosalicylate at a stable dose (specified below) for at least 4 weeks:
5.1. Sulphasalazine greater than 1.5 g/day
5.2. Pentasa (slow release mesalazine) greater than 750 mg/day
5.3. Asacol (mesalazine) or generic equivalents greater than 800 mg/day
5.4. Colazide (balsalazide) greater than 2.25 g/day
5.5. Dipentum (olsalazine) greater than 750 mg/day
6. Patients on combined treatment with azathioprine (or 6-MP) and an aminosalicylate for a minimum of 6 months but no more than 4 years without relapse. Patients may enter if they have briefly been off either treatment during this time (e.g., because of abnormal blood test results) but prescription of each drug should cover at least 85% of the period of time for continuous drug treatment to be declared. N.B. Duration of aminosalicylate may be longer.
7. Patients who have given written informed consent

Exclusion Criteria

1. Patients with Crohn?s disease
2. Patients with a baseline Walmsley Simple Activity Index greater than 2
3. Patients with a baseline sigmoidoscopy grade of greater than 2 (Baron Scale)
4. Patients requiring long term treatment with oral steroids for any medical condition
5. Women who are pregnant or lactating
6. Patients with known human immunodeficiency virus (HIV) infection
7. Other serious medical or psychiatric illness currently ongoing, or experienced within the past three months, that in the opinion of the investigator would compromise the study
8. Patients unable to comply with the protocol requirements, including severe alcohol and drug use

Study & Design

• Study Type: Interventional
• Study Design: Not specified