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| Evaluation of H. pylori infection in aspirin users - pilot study |
| Source of record | UK Trials |
| ISRCTN | ISRCTN10740230 |
| Date ISRCTN assigned | 27/03/2008 |
| Local reference number(s) | G0700648 |
| Public title | Evaluation of H. pylori infection in aspirin users - pilot study |
| Scientific title | Helicobacter pylori Eradication vs Aspirin Toxicity pilot study |
| Acronym | HEAT |
| Disease/condition/study domain | Ulcer bleeding |
| Study hypothesis | Eradication of H. pylori in patients taking aspirin regularly will reduce the risk of ulcer bleeds. |
| Design/methodology | Part 1: Interventional, non-randomised controlled study. Part 2: Observational database study. |
| Research ethics review | Nottingham 2 Research Ethics Committee, approved on 21 September 2007. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Male and female patients aged 45 years of age or older 2. Patients who have given written informed consent 3. Patients taking aspirin (less than or equal to 300 mg daily) NB: Patients who have previously been tested for H. pylori and/or had previous eradication therapy will not be excluded. |
| Participants - exclusion criteria | 1. Patients currently taking anti-ulcer therapy (H2-receptor antagonists i.e. cimetidine, famotidine, nizatidine or ranitidine and Proton Pump Inhibitors [PPIs] i.e. esomeprazole, lansoprazole, omeprazole, pantoprazole or rabeprazole sodium) 2. Patients currently taking non-selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (aceclofenac, acemetacin, azapropazone, dexibuprofen, dexketoprofen, diclofenac sodium, diflunisal, fenbufen, fenoprofen, flurbiprofen, ibuprofen, indometacin, ketoprofen, mefenamic acid, meloxicam, nabumetone, naproxen, piroxicam, sulindac, tenoxicam, or tiaprofenic acid) 3. Patients who are terminally ill 4. Patients who are allergic to any of the eradication treatment drugs 5. Patients who are currently being treated with an antibacterial or have had antibacterial treatment within the last 4 weeks 6. Patients who have had treatment with a PPI (listed above) within the last 2 weeks. 7. Women who are pregnant or breast feeding |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Anticipated start date | 01/02/2008 |
| Anticipated end date | 31/07/2008 |
| Status of trial | Ongoing |
| Target number of participants | 905 |
| Interventions | This trial has two parts: Part 1: Interventional study. This study will establish the H. pylori infection rates and success of eradication therapy. GPs will screen their patient records for potential participants (Aged >45 and on <300 mg aspirin/day, excluding ulcer healing drugs and NSAIDs) and write to them to invite them to take part in the study. All participants will have a 13C Urea breath test (to establish their H. pylori status) and a blood sample taken (for future H. pylori serology testing). For participants who test negative for H. pylori, this will be the end of their involvement in the study. All patients who test positive for H. pylori (there will be no randomisation) will be given eradication therapy (Clarithromycin 500 mg twice a day [bd], omeprazole 20 mg bd and metronidazole 400 mg bd. Eradication treatment will last 7 days), and retested 6-8 weeks later to test eradication success. Part 2: Observational study. This is a database study to assess aspirin use in the target population and rates of ulcer bleeds. |
| Primary outcome measure(s) | 1. Rate of aspirin use (results of Part 2 Observational study) 2. Rate of ulcer bleeding in patients using aspirin (results of Part 2 Observational study) 3. Level of H. pylori infection and subsequent eradication rates in aspirin patients at 6-8 weeks after the eradication therapy 4. Level of interest from GPs and patients for a randomised study and their preferred enrolment site |
| Secondary outcome measure(s) | None |
| Sources of funding | Medical Research Council (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 9515679 |
| Sponsor email | paul.cartledge@nottingham.ac.uk |
| Contact name | Prof Chris Hawkey |
| Contact details | Wolfson Digestive Diseases Centre University Hospital Nottingham United Kingdom NG7 2UH |
| Contact telephone | +44 (0)115 8231033 |
| Contact email | cj.hawkey@nottingham.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN10740230 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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