E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients suffering from chronic pain of neuropathic character after open hernia repair. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049475 |
E.1.2 | Term | Chronic pain |
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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 investigate whether pregabalin at a dose of 150-600 mg in two divided doses a day reduces pain in patients with chronic neuropathic pain after herniorraphy. This research question will be answered by testing of the following hypothesis:
- Treatment with pregabalin (150-600 mg dose) results in a statistically significant improvement in endpoint mean pain score of ≥ 1,2 during 8 weeks follow-up relatively to treatment with placebo |
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E.2.2 | Secondary objectives of the trial |
The secondary objective
- The difference in quantitative sensory testing (QST) thresholds between the painful inguinal area and the normal contra-lateral side in patients of which the chronic pain is treated by pregabalin is clinical significant greater than the difference found in patients of which the chronic pain is treated by placebo
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. History of unilateral inguinal herniotomy 2. Establishment of neuropathic character of chronic pain by means the LANSS painscore and DN4 score 3. Abnormal sensitivity (allodynia, dysesthesia, hypoesthesia or dysesthesia) in or around the incisional area 4. Duration pain ≥ 3 months 5. Gender: Male 6. Medial or lateral inguinal hernia 7. Age ≥ 18 years 8. Description III or IV of pain interfering with daily activity 9. VAS score ≥ 40 mm on Vas scale on which they indicate ‘how unpleasant or disturbing the worst pain was that they had today’ 10. Informed consent (addendum V)
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E.4 | Principal exclusion criteria |
1. Participation in another trial 2. Bilateral hernia 3. Recurrent hernia 4. Age < 18 years 5. Cognitive disfunction 6. Patient is unable to speak Dutch 7. Description I or II of pain interfering with daily activity 8. Patient classified as American Society of Anaesthesiologist Class 4
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome is the mean 11-point numerical pain rating score in both treatment groups at baseline and follow-up. |
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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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | No |
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 | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
E.8.1.6 | Cross over | No |
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 | Yes |
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 secondary outcomes are the mean light-touch and thermal QST thresholds between the painful inguinal area and the normal contra-lateral side in patients from both treatment groups at baseline and follow-up. |
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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 |