Pain
Conditions
Brief summary
The purpose of this study is to determine the effectiveness of different doses of \[S,S\]-Reboxetine in the treatment of chronic pain following a shingles infection
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 \>/=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
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 14 will be calculated | — |
Secondary
| Measure | Time frame |
|---|---|
| - The mean endpoint (week 14) sleep interference score change from baseline - Analysis of the Medical Outcomes Study Sleep Scale - Analysis of the Patient Global Impression of Change - Analysis of the SF-36 Health Survey | — |
Countries
United States
Outcome results
None listed