MedDRA version: 7.1 Level: LLT Classification code 10054095
Conditions
Interventions
Product Name: gabapentin
Pharmaceutical Form: Capsule*
INN or Proposed INN: gabapentin
CAS Number: 60142-96-3
Other descriptive name: 1-
Sponsors
Pfizer Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: To assess the response of the Neuropathic Pain Symptom Inventory to changes in drug treatment.;Primary end point(s): Average daily pain score | — |
Countries
United Kingdom
Outcome results
None listed