[S,S]-Reboxetine Add-On Trial

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Pain

Treatments: Drug: Pregabalin; Drug: [S,S]-Reboxetine + Pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00334685

A6061021

Details and patient eligibility

About

The purpose of this study is to determine the effectiveness of adjunctive treatment of pregabalin with [S,S]-Reboxetine against pregabalin monotherapy in patients with PHN

Enrollment: 136 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 shingles skin rash
• Patients at screening must have a score >/=40 mm on the pain visual analogue scale

Exclusion criteria

• Patients with significant renal and hepatic impairment
• Patients with other severe pain, that may impair the self-assessment of the pain due to shingles
• Patients with clinically abnormal electrocardiogram

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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136 participants in 2 patient groups

[S,S]-Reboxetine + Pregabalin

Experimental group

Treatment:

Drug: [S,S]-Reboxetine + Pregabalin

Pregabalin

Active Comparator group

Treatment:

Drug: Pregabalin