Pain
Conditions
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.
Interventions
DRUG[S,S]-Reboxetine
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs | — |
| Physical examination | — |
| 12-lead ECG | — |
| Hematology/Biochemistry | — |
| Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| EQ-5D | — |
| Pain Visual Analogue Scale | — |
| Pain-related Medication Utilization | — |
| Analgesic Treatment Satisfaction Scale | — |
| Patient Global Impression of Change | — |
| Neuropathic Pain Symptom Inventory | — |
| Modified Brief Pain Inventory - Short Form | — |
| SF-12 Health Survey | — |
Countries
Argentina, Canada, Chile, Croatia, India, Lithuania, Mexico, Poland, Spain, Sweden, United Kingdom, United States
Outcome results
None listed