Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN)

Viatris

Status and phase: Completed; Phase 4

Conditions: Postherpetic Neuralgia ( PHN )

Treatments: Drug: Lyrica (pregabalin); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01455428

A0081276

Details and patient eligibility

About

To prove pregabalin is effective in relieving pain compared with placebo in subjects with postherpetic neuralgia (PHN).

Enrollment: 223 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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223 participants in 2 patient groups, including a placebo group

Lyrica (pregabalin)

Experimental group

Treatment:

Drug: Lyrica (pregabalin)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo