Condition category
Digestive System
Date applied
18/04/2008
Date assigned
16/06/2008
Last edited
23/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.bartsandthelondon.org.uk/research

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

  1. 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.

Additional files

Editorial Notes