The effect of pregabalin on human visceral pain hypersensitivity
| ISRCTN | ISRCTN40924266 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40924266 |
| Secondary identifying numbers | Version 1 (03/04/07), MHRA 13904/0203/001-0001 |
- Submission date
- 18/04/2008
- Registration date
- 16/06/2008
- Last edited
- 23/11/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Yang Chua
Scientific
Scientific
Gastrointestinal physiology
3rd Floor Alaxandra Wing
Royal London Hospital
London
E1 1BB
United Kingdom
| Phone | +44 (0)207 377 7000 (ext 3456) |
|---|---|
| y.c.chua@qmul.ac.uk |
Study information
| Study design | Single-centre, placebo-controlled, double-blind, randomised, two-period, cross-over study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Study objectives | 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(s) | 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). |
| Health condition(s) or problem(s) studied | Acid reflux, epigastric pain. |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Pregabalin |
| Primary outcome measure | 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 measures | 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) |
| Overall study start date | 01/04/2008 |
| Completion date | 30/04/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 16 |
| Key inclusion criteria | 1. Age >18 and <60 2. Both males and females |
| Key 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 |
| Date of first enrolment | 01/04/2008 |
| Date of final enrolment | 30/04/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Gastrointestinal physiology
London
E1 1BB
United Kingdom
E1 1BB
United Kingdom
Sponsor information
Barts and the London NHS Trust and Queen Mary, University of London (UK)
Hospital/treatment centre
Hospital/treatment centre
Joint Research and Development Office
24-26 Walden Street
Whitechapel
London
E1 2AJ
England
United Kingdom
| Phone | +44 (0)207 882 7272 |
|---|---|
| david.jackson@bartsandthelondon.nhs.uk | |
| Website | http://www.bartsandthelondon.org.uk/research |
Funders
Funder type
Industry
Pfizer UK Ltd (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2012 | Yes | No |
