Contact information
Type
Scientific
Primary contact
Dr Yang Chua
ORCID ID
Contact details
Gastrointestinal physiology
3rd Floor Alaxandra Wing
Royal London Hospital
London
E1 1BB
United Kingdom
+44 (0)207 377 7000 (ext 3456)
y.c.chua@qmul.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 1 (03/04/07), MHRA 13904/0203/001-0001
Study information
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
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.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Pregabalin
Primary outcome measures
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 trial start date
01/04/2008
Overall trial end date
30/04/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age >18 and <60
2. Both males and females
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
16
Participant 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
Recruitment start date
01/04/2008
Recruitment end date
30/04/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Gastrointestinal physiology
London
E1 1BB
United Kingdom
Sponsor information
Organisation
Barts and the London NHS Trust and Queen Mary, University of London (UK)
Sponsor details
Joint Research and Development Office
24-26 Walden Street
Whitechapel
London
E1 2AJ
United Kingdom
+44 (0)207 882 7272
david.jackson@bartsandthelondon.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
Pfizer UK Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22211824
Publication citations
-
Results
Chua YC, Ng KS, Sharma A, Jafari J, Surguy S, Yazaki E, Knowles CH, Aziz Q, Randomised clinical trial: pregabalin attenuates the development of acid-induced oesophageal hypersensitivity in healthy volunteers - a placebo-controlled study., Aliment. Pharmacol. Ther., 2012, 35, 3, 319-326, doi: 10.1111/j.1365-2036.2011.04955.x.