TCR Clinical Trials Support
Clinical Trials Software - STATIC
STATIC ('Stopping Aminosalicylate Therapy in Inactive Crohn's Disease') aims to answer the question of whether oral 5-ASAs, or aminosalicylates, should be continued in patients with Crohn's disease in remission.
Crohn's disease is a chronic inflammatory disorder of the digestive system. It is characterised by diarrhoea, weight loss and abdominal pain. It is estimated that one in every 650 people in the UK have Crohn's disease. Treatment for Crohn's is principally by medication. Surgical intervention may be required in some cases. 5-ASAs are one of the main groups of medications currently used to treat Inflammatory Bowel Disease. They help reduce inflammation in the lining of the intestine. Examples include mesalazine, olsalazine, sulphalazine, and balsalazide. Oral 5-ASAs are generally the first line of treatment. They are used for inducing and maintaining remission in patients with ulcerative colitis and Crohn's disease. Oral 5-ASAs are also used to prevent postoperative recurrence.
However, there is uncertainty regarding their effectiveness for patients with Crohn's disease. A review of clinical trials that tested 5-ASAs in Crohn's disease patients showed little evidence that they are any more effective than placebo in maintaining remission. This is a large, randomised control trial. It aims to recruit over 1,500 patients from over 1000 GP practices in the UK, and also from hospitals in the UK, Europe and North America.
We are looking to recruit individuals who are: Aged 18 and over with Crohn's disease Currently taking oral 5-ASAs, and In clinical remission Once recruited, individuals will be randomly assigned to either stop, or continue, taking their 5-ASA medication. All participants will receive their usual medical care.
Sponsor Alimentiv Inc, Canada
Chief Investigator Dr Gordon Moran University of Nottingham
Trial Office STAR (Simple Trials for Academic Research) Team University of Nottingham
staticstudy@nottingham.ac.uk
Clinical Trials Software - HEAT
HEAT
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HEAT (Helicobacter Eradication Aspirin Trial) is a large simple double-blind placebo controlled outcomes study of Helicobacter pylori (H. pylori) eradication to prevent ulcer bleeding in aspirin users. It is run by the University of Nottingham, with recruiting centres across the UK. This trial is funded by the National Institute of Health Research Health Technology Assessment (NIHR HTA) Programme.
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There are 1,340 practices across the UK participating in this trial with 30,000 enrolled patients
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We provide detailed toolkits for all participating practices, and an overarching N3 hosted web system to manage the clinical trial
Clinical Trials Software - ATTACK
ATTACK
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ATTACK (Aspirin To Target Arterial Events In Chronic Kidney Disease). This new clinical trial has now begun and will investigate the use of aspirin to reduce stroke and heart attacks in patients with established CKD
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We provide detailed toolkits for all participating practices, and an overarching N3 hosted web system to manage the clinical trial