A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Postherpetic Neuralgia

Viatris

Status and phase: Completed; Phase 3

Conditions: Neuralgia, Postherpetic

Treatments: Drug: Pregabalin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00394901

A0081120

Details and patient eligibility

About

The purpose of this study is to evaluate efficacy and safety of pregabalin in the treatment of postherpetic neuralgia in a dose-ranging manner.

Enrollment: 372 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Visual Analogue Scale (VAS) of pain is higher than 40 mm.
• Pain is sustained for more than 3 months after healing of herpes zoster skin rash.

Exclusion criteria

• Malignancy within the past 2 years.
• Patients who have undergone neurolytic or neurosurgical therapy for postherpetic neuralgia.
• Creatinine clearance </= 30 mL/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft and Gault equation, by omitting any decimal fractions).
• Patients having other severe pain which may impair the self assessment of the pain due to postherpetic neuralgia.
• Skin conditions in the affected dermatome that could alter sensation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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372 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Pregabalin 150mg/day

Experimental group

Treatment:

Drug: Pregabalin

Drug: Pregabalin

Drug: Pregabalin

Pregabalin 300mg/day

Experimental group

Treatment:

Drug: Pregabalin

Drug: Pregabalin

Drug: Pregabalin

Pregabalin 600mg/day

Experimental group

Treatment:

Drug: Pregabalin

Drug: Pregabalin

Drug: Pregabalin