Overview

Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN)

Status:
Completed
Trial end date:
2014-01-01
Target enrollment:
0
Participant gender:
All
Summary
To prove pregabalin is effective in relieving pain compared with placebo in subjects with postherpetic neuralgia (PHN).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Treatments:
Pregabalin
Criteria
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 ﹥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 ﹥3