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| Controlled Assessment of Salicylate and Azathioprine |
| Source of record | UK Trials |
| ISRCTN | ISRCTN99666810 |
| Date ISRCTN assigned | 30/01/2008 |
| Local reference number(s) | N/A |
| Public title | Controlled Assessment of Salicylate and Azathioprine |
| Scientific title | A randomised, open study of aminosalicylate withdrawal in patients with ulcerative colitis in established remission on combination treatment of azathioprine (or 6-mercaptopurine) and an aminosalicylate |
| Acronym | CASA |
| Disease/condition/study domain | Ulcerative colitis |
| Study hypothesis | To investigate whether azathioprine alone is as effective as azathioprine and a 5-aminosalicylic acid (5-ASA) compound in maintaining recently established remission in patients on both drugs. |
| Design/methodology | This will be a randomised, open, multi-centre, withdrawal study. There will be two phases: phase 1, the primary outcome measure over one year, and phase 2, ongoing follow-up out to 3 years. |
| Research ethics review | Ethics approval received from the Cambridgeshire 4 Research Ethics Committee (REC) (formerly Eastern MREC) on the 15th September 2005. |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material | |
| Anticipated start date | 01/02/2006 |
| Anticipated end date | 31/12/2009 |
| Status of trial | Ongoing |
| Target number of participants | 410 |
| Interventions | At enrolment patients (already taking azathioprine and a 5-ASA) will have bloods taken and have a sigmoidoscopy to confirm remission. They will then be randomised to: 1. Mono-therapy (i.e. withdraw their existing 5-ASA and take azathioprine only) 2. Dual-therapy (i.e. continue as normal on azathioprine and their existing 5-ASA) They will remain on their randomised therapy for 12 months, after which the clinician will review their treatment. Patients will be followed up every 3 months by either telephone contact or clinic visit. Their blood results, which are done every 2 - 3 months by routine NHS azathioprine blood monitoring, will be recorded as part of the study. They will also be followed up after 24 months and 36 months by clinic visit. |
| Primary outcome measure(s) | Relapse rates of azathioprine mono-therapy compared to azathioprine and salicylate dual therapy over the first 12 months. |
| Secondary outcome measure(s) | Factors predictive of success of the different treatment regimes. |
| Sources of funding | Moulton Charitable Foundation (UK) |
| Sponsor name | University of Nottingham (UK) |
| Sponsor details | Research Innovation Services King's Meadow Campus Lenton Lane Nottingham United Kingdom NG7 2NR |
| Sponsor telephone | +44 (0)115 951 5679 |
| Sponsor email | paul.cartledge@nottingham.ac.uk |
| Sponsor website | http://www.nottingham.ac.uk/ |
| Contact name | Prof Richard Logan |
| Contact details | Division of Epidemiology and Public Health Queens Medical Centre Nottingham United Kingdom NG7 2UH |
| Contact telephone | +44 (0)115 823 0452 |
| Contact email | Richard.Logan@nottingham.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN99666810 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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