Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN) (NCT01455428) | Clinical Trial Compass
CompletedPhase 4
Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN)
China223 participantsStarted 2011-12
Plain-language summary
To prove pregabalin is effective in relieving pain compared with placebo in subjects with postherpetic neuralgia (PHN).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female Chinese subjects, ages ≥18 at screening
* Subjects with symptoms of neuropathic pain associated with postherpetic neuralgia (PHN). Subjects must have pain present for ï¹¥3 months after healing of the acute herpes zoster skin rash
* At screening (V1), subjects must have a score ≥40mm on the 100-mm visual analog scale (VAS) of the Short Form-McGill Pain Questionnaire (SF-MPQ, see Appendix 3)
* At randomization (V2), subjects must have a score ≥40mm on the 100-mm visual analog scale (VAS) of the Short Form-McGill Pain Questionnaire (SF-MPQ, see Appendix 3)
* At randomization (V2), subjects must have completed at least 5 daily pain diaries (DPRS, see Appendix 2) and have an average daily pain score ≥4 over the past 7 days
Exclusion Criteria:
* Subjects who demonstrate a high response to placebo, with 30% decrease on the Pain Visual Analog Scale (VAS) at randomization as compared to screening
* Subjects who have a high variability in pain scores during the 1 week screening period, with any difference between two scores ï¹¥3
What they're measuring
1
Baseline Mean Pain Score
Timeframe: Baseline
2
Change From Baseline in Mean Pain Score at Endpoint
Timeframe: Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)
Trial details
NCT IDNCT01455428
SponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.