[S,S]-Reboxetine Long Term Safety Study In Post-Shingles Pain.

Phase 2TerminatedNCT00354094

Pfizer600 enrolled

Overview

The purpose of this study is to assess the long term (up to 2 years) safety and tolerability of \[S,S\]-Reboxetine in patients with pain after shingles.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

600

Conditions

Pain

Interventions

[S,S]-ReboxetineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients must have pain present for more than 3 months after healing of the shingles skin rash. * Patients at screening must have a score of \>/=40mm on the pain visual analogue scale. Exclusion Criteria: * Patients with significant hepatic impairment. * Patients with other severe pain, that may impair the self-assessment of pain due to postherpetic neuralgia (pain after shingles).

Locations (40)

Outcomes

Primary Outcomes

Vital signs

Physical examination

12-lead ECG

Hematology/Biochemistry

Adverse events

Secondary Outcomes

Pain Visual Analogue Scale

Patient Global Impression of Change

Neuropathic Pain Symptom Inventory

Modified Brief Pain Inventory - Short Form

SF-12 Health Survey

EQ-5D

Analgesic Treatment Satisfaction Scale

Pain-related Medication Utilization

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Greensboro, North Carolina, United States

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Fargo, North Dakota, United States

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Cumberland, Rhode Island, United States

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San Antonio, Texas, United States

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Buenos Aires, Buenos Aires, Argentina

Pfizer Investigational Site

Buenos Aires, Argentina

Pfizer Investigational Site

Buenos Aires, Argentina

Pfizer Investigational Site

Buenos Aires, Argentina

...and 30 more locations