Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia

Viatris

Status and phase: Completed; Phase 3

Conditions: Post Herpetic Neuralgia

Treatments: Drug: Pregabalin; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01270828

A0081224

2009-016766-86 (EudraCT Number)

Details and patient eligibility

About

The purpose of the study is to explore the safety and efficacy of a new once a day pregabalin formulation versus placebo for patients with post herpetic neuralgia (Shingles)

Enrollment: 806 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must have pain present for more than 3 months after the healing of the herpes zoster skin rash.
• At screening (V1) and enrollment (V2), patients must have a score of greater than or equal to 4 on the Pain Numeric Rating Scale (1 week recall period).
• At enrollment (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be greater than or equal to 4.
• Male or female of any race, at least 18 years of age, and using appropriate methods of contraception

Exclusion criteria

• Creatinine clearance <30 mL/min (estimated from serum creatinine).
• Skin conditions in the affected dermatome that could alter sensation
• Pregabalin use in the last 30 days. Subjects taking pregabalin in the last 30 days should be washed out of pregabalin for at least 30 days prior to screening visit. Patients who had not responded to pregabalin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

806 participants in 2 patient groups, including a placebo group

Pregablain CR tablet 82.5 to 660mg

Experimental group

Treatment:

Drug: Pregabalin

Placebo

Placebo Comparator group

Treatment:

Drug: placebo