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| [ Print-friendly version ] |
| The effect of pregabalin on human visceral pain hypersensitivity |
| ISRCTN | ISRCTN40924266 |
| ClinicalTrials.gov identifier | |
| Public title | The effect of pregabalin on human visceral pain hypersensitivity |
| Scientific title | Effects of pregabalin on acid-induced oesophageal pain hypersensitivity in male and female healthy adult volunteers, as investigated in a single-centre, placebo-controlled, double-blind, randomised, two-period, cross-over study |
| Acronym | N/A |
| Serial number at source | Version 1 (03/04/07), MHRA 13904/0203/001-0001 |
| Study hypothesis |
Does pregabalin attenuate or prevent acid-induced oesophageal secondary hyperalgesia (pain)?
Please note that, as of 06/10/2008, the start and end dates of this trial have been updated from 01/05/2007 and 01/05/2008 to 01/04/2008 and 30/04/2009. The change is due to delays in preparation for the trial. |
| Ethics approval | North West Research Ethics Committee. Date of approval: 04/07/2007 (ref: 07/MRE08/39). Amendment approved on 01/09/2007 (change of site from Manchester to London). |
| Study design | Single-centre, placebo-controlled, double-blind, randomised, two-period, cross-over study. |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Acid reflux, epigastric pain. |
| Participants - inclusion criteria |
1. Age >18 and <60
2. Both males and females |
| Participants - exclusion criteria |
1. Currently on any medication
2. Known chronic medical illness 3. Previous or current psychiatric illness 4. Any upper gastrointestinal (GI) symptoms (heartburn, reflux-like, acid brash, epigastric pain, nausea and vomiting) 5. History of upper GI surgery 6. History of chest pain or discomfort 7. Anti-acid medication prescribed by doctor (proton pump inhibitors [PPI] or H2 antagonists) 8. Recent illnesses such as flu or cold in the preceding 2 weeks of the study 9. Pregnancy |
| Anticipated start date | 01/04/2008 |
| Anticipated end date | 30/04/2009 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | 16 |
| Interventions |
This is a cross-over study, and therefore the order of the treatment allocation is randomised. The wash-out period is 2 weeks.
Intervention: Five-day treatment with pregabalin Days 1-3: 75 mg twice a day (bd) Day 4: 150 mg bd Day 5: 150 mg single dose in the morning Placebo treatment: This will be administered as above. |
| Primary outcome measure(s) |
Change in oesophageal pain threshold to electrical stimuli will be assessed by the Bernstein test. The participants will be asked to rate any discomfort or pain with a visual analogue scale before an acid infusion and 30 and 90 mins after the acid infusion. This test will be carried out at Visit 1, 2 and 3.
Timepoints: Visit 1: Prior to randomisation Visit 2: After the end of the first 5-day treatment (pregabalin or placebo) Visit 3: At least 2 weeks after Visit 2 and at the end of the second 5-day treatment (pregabalin or placebo) |
| Secondary outcome measure(s) |
1. To assess whether psychological state or trait of the participants determine the magnitude of acid induced oesophageal hypersensitivity. The psychological state and trait of the participants will be assessed by questionnaires at Visit 1.
2. To assess whether an individual's autonomic profile (heart rate, blood pressure, etc) determines the magnitude of acid-induced oesophageal pain hypersensitivity and the effect of pregabalin. The autonomic measurements will be carried out at Visit 1, 2 and 3. Timepoints: Visit 1: Prior to randomisation Visit 2: After the end of the first 5-day treatment (pregabalin or placebo) Visit 3: At least 2 weeks after Visit 2 and at the end of the second 5-day treatment (pregabalin or placebo) |
| Sources of funding | Pfizer UK Ltd (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Yang Chua |
| Address |
Gastrointestinal physiology
3rd Floor Alaxandra Wing Royal London Hospital |
| City/town | London |
| Zip/Postcode | E1 1BB |
| Country | United Kingdom |
| Tel | +44 (0)207 377 7000 (ext 3456) |
| y.c.chua@qmul.ac.uk | |
| Sponsor | Barts and the London NHS Trust and Queen Mary, University of London (UK) |
| Address |
Joint Research and Development Office
24-26 Walden Street Whitechapel |
| City/town | London |
| Zip/Postcode | E1 2AJ |
| Country | United Kingdom |
| Tel | +44 (0)207 882 7272 |
| Fax | +44 (0)207 882 7277 |
| david.jackson@bartsandthelondon.nhs.uk | |
| Sponsor website: | http://www.bartsandthelondon.org.uk/research |
| Date applied | 18/04/2008 |
| Last edited | 06/10/2008 |
| Date ISRCTN assigned | 16/06/2008 |
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