The effect of pregabalin on human visceral pain hypersensitivity

ISRCTN	ISRCTN40924266
DOI	https://doi.org/10.1186/ISRCTN40924266
Protocol serial number	Version 1 (03/04/07), MHRA 13904/0203/001-0001
Sponsor	Barts and the London NHS Trust and Queen Mary, University of London (UK)
Funder	Pfizer UK Ltd (UK)

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

Gastrointestinal physiology
3rd Floor Alaxandra Wing
Royal London Hospital
London
E1 1BB
United Kingdom

Phone	+44 (0)207 377 7000 (ext 3456)
Email	y.c.chua@qmul.ac.uk

Study information

Primary study design	Interventional
Study design	Single-centre, placebo-controlled, double-blind, randomised, two-period, cross-over study.
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Pregabalin
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)
Key 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)
Completion date	30/04/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Gastrointestinal physiology

London
E1 1BB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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