Neuralgia, Postherpetic Clinical Trial
Official title:
Study PXN110527: The Investigation of the Efficacy and Pharmacokinetics of XP13512 in Subjects With Neuropathic Pain Associated With Post-herpetic Neuralgia (PHN) Who Have Had an Inadequate Response to Gabapentin Treatment.
The purpose of this study is evaluate the difference between two doses of gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, on pain associated with post-herpetic neuralgia.
The primary purpose of study PXN110527 was to investigate the efficacy of a high
(3600mg/day) dose versus a low (1200mg/day) dose of GEn in subjects with post-herpetic
neuralgia (PHN) who have a history of an inadequate response to gabapentin treatment. The
study is a cross-over design. Prior to screening subjects are required to have a
demonstrated history of an inadequate response (as determined by the investigator) to at
least 1800 mg/day of gabapentin. Prior history of treatment with gabapentin includes current
treatment at 1800mg/day (2 weeks) or prior treatment with ≥1800mg/day (4 weeks). Subjects
could also have been treated with pregabalin monotherapy (150-300mg/day, ≥4 weeks) and had
an inadequate response.
Subjects are treated with gabapentin 1800mg/day during the Baseline Period and are
randomized if during the Basleline Period they are compliant with gabapentin treatment and
have a 24-hour average pain intensity score ≥4.0 based on an 11-point pain intensity
numerical rating scale (PI-NRS). Subjects are then randomized to receive gabapentin
enacarbil (either 1200mg/day or 3600mg/day in a 1:1 ratio) for Treatment Period 1 (28 days).
Followed by a dose of 2400mg/day for 4 days and the alternate fixed dose (either 3600 mg/day
or 1200 mg/day) for Treatment Period 2 (28 days).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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