Pain
Conditions
Brief summary
The purpose of this study is to determine the effectiveness of \[S,S\]-Reboxetine in the treatment of chronic pain following a shingles infection in patients who are Gabapentin treatment failures.
Interventions
DRUG[S,S]-Reboxetine
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
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 the healing of shingles skin rash. * Patients at screening must have a score \> or = 40 mm on the pain visual analogue scale.
Exclusion criteria
* Patients with poor renal function. * Patients with other severe pain, that may impair the self-assessment of the pain due to shingles. * Patients with abnormal electrocardiogram.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 5 will be calculated. | — |
Secondary
| Measure | Time frame |
|---|---|
| - The mean endpoint (week 5) sleep interference score change from baseline - Analysis of the Patient Global Impression of Change - Analysis of the Clinical Global Impression of Change - Analysis of the SF-McGill questionnaire | — |
Outcome results
None listed