This study will test the effects of Pregabalin in a validated model of visceral pain hypersensitivity (VPH) in healthy volunteers. The volunteers must be free of medical conditions. VPH is thought to contribute to the production of abdominal pain in patients with functional gastrointestinal disorders such as Irritable Bowel Syndrome. If the drug was effective in attenuating VPH in our model then it would be considered for use in patients with these disorders. MedDRA version: 14
Conditions
Interventions
Product Name: Pregabalin
Product Code: PD 0144723 (CI-1008)
Pharmaceutical Form: Capsule
INN or Proposed INN: Pregabalin
CAS Number: 148
Sponsors
Queen Mary, University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged 18-60 (GI Physiology is different in those aged 60). 2. Normal oesophageal motor function as assessed by oesophageal manometry (to include only normal subjects). 3. Healthy (to control for factors that may affect the development of visceral hypersensitivity). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. A prior history of gastroesophageal reflux/chest pains (as the study aims to define physiological responses in asymptomatic individuals). 2. Participants are required to speak English (as the study is dependent on the subjective reporting of pain thresholds and adverse effects which could not be undertaken through an interpreter). 3. A history of gastric acid suppressive therapy in the last 8 weeks (as this may affect the outcome of the acid infusion). 4. Chronic disease especially gastrointestinal, functional, psychiatric or neurological (to ensure normal physiology is being studied). 5. Pregnancy (acid infusion into the gullet has never been performed in pregnant subjects and therefore will be avoided).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to explore whether Pregabalin reduces or prevents acid-induced oesophageal hypersensitivity compared to placebo, in male and female healthy adult volunteers.; Secondary Objective: To determine whether pregabalin reduces baseline pain thresholds To determine whether psychological state or trait determines the magnitude of acid induced oesophageal hypersensitivity, and the effect of pregabalin, and To determine whether an individual's autonomic profile (heart rate and blood pressure responses) determines the magnitude of acid induced oesophageal hypersensitivity, and the effect of pregabalin. ;Primary end point(s): The primary end point of the study will be the change in the upper oesophageal pain threshold post-acid-infusion compared to baseline (drug versus placebo). | — |
Countries
United Kingdom
Outcome results
None listed