The effect of pregabalin on human visceral pain hypersensitivity

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN40924266

Enrollment

Registered

2008-06-16

Start date

2008-04-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acid reflux, epigastric pain. Digestive System Gastro-oesophageal reflux disease

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age >18 and <60 2. Both males and females

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026