[S,S]-Reboxetine Long Term Safety Study In Post-Shingles Pain.
Phase 2
Terminated
- Conditions
- Pain
- Registration Number
- NCT00354094
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 600
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.
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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).
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Vital signs Physical examination 12-lead ECG Hematology/Biochemistry Adverse events
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇬🇧London, United Kingdom