E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10023003 |
E.1.2 | Term | Irritable bowel syndrome |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female subjects aged 18−60 (GI Physiology is different in those aged <18 or >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). |
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E.4 | Principal 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). |
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E.5 End points |
E.5.1 | 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). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is defined as the last visit of the last subject undergoing the trial as defined in the study protocol. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |