E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054095 |
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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 |
To estimate the difference in average daily pain score (ADPS) after 4 weeks in patients maintained on the ‘standard’ dose of gabapentin compared to those on a reduced dose of gabapentin. To estimate the variability of ADPS at 4 weeks for both groups. To investigate the time to onset of maximum pain following gabapentin dose-reduction. |
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E.2.2 | Secondary objectives of the trial |
To assess the response of the Neuropathic Pain Symptom Inventory to changes in drug treatment. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Male or female, aged 18 and over - Female patients must be non-pregnant and non-lactating, and be postmenopausal, surgically sterilized, or using an appropriate method of contraception (hormonal or intrauterine device), throughout and four weeks after completion of the study. - Patients with neuropathic pain, defined as pain initiated or caused by a primary lesion or dysfunction in the nervous system (IASP 1994 definition). If pain is of mixed origin then it must have a predominantly neuropathic component as defined by a total score of ³ 4 on the DN4 questionnaire (Bouhassira et al., 2004b). - Patients who are known to respond to gabapentin at a daily dose of 1200, 1500, or 1800 mg, which has not been adjusted within 4 weeks of screening. A responder is defined by the following: . a documented reduction of global pain of ³ 50% following the start of gabapentin treatment. If documentary evidence is not available then a Patient’s Global Impression of Change (PGIC) of “much improved” or “very much improved” following the start of gabapentin treatment is acceptable provided the patient has been on gabapentin for £ 6 months, and a global pain score £ 4 on an 11-point scale at screening. |
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E.4 | Principal exclusion criteria |
- Patients with trigeminal neuralgia- Patients with pain of mixed origin (eg, chronic lower back pain, head pain, visceral pain, etc) unless there is a documented predominant neuropathic component responsive to gabapentin. - Patients with any co-existing pain which he/she cannot differentiate from the neuropathic pain. - Patients with any evidence of clinically significant renal impairment. - Patients with any clinically significant abnormality following review of pre-study laboratory data and full physical examination. - History of chronic hepatitis B or C, acute hepatitis A, B, or C within the past 3 months, or HIV infection. - Participation in a clinical trial for an investigational drug and/or agent within 30 days prior to screening. - Patients who have a history of alcohol or illicit drug abuse in the past 2 years. - Use of prohibited medications as defined, unless the appropriate washout period has been observed. - Clinically significant or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise participation in the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
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) | 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 | Information not present in EudraCT |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 10 |