Pain
Conditions
Brief summary
The purpose of this study is to determine the effectiveness of adjunctive treatment of pregabalin with \[S,S\]-Reboxetine against pregabalin monotherapy in patients with PHN
Interventions
DRUG[S,S]-Reboxetine + Pregabalin
\[S,S\]-Reboxetine oral, tablet 2, 4 or 6 mg per day for 10 weeks Pregabalin oral, capsule, 75, 150, 300 or 600 mg per day for 14 weeks
DRUGPregabalin
Pregabalin oral, capsule, 75, 150, 300 or 600 mg per day for 14 weeks
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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 10 will be calculated | Week 10 |
Secondary
| Measure | Time frame |
|---|---|
| The mean endpoint (week 10) sleep interference score change from baseline | Week 10 |
| Analysis of the Medical Outcomes Study Sleep Scale | Week 10 |
| Analysis of the Patient Global Impression of Change | Week 10 |
| Analysis of the Neuropathic Pain Symptom Inventory | Week 10 |
Countries
Austria, Canada, Czechia, Germany, Italy, Latvia, Netherlands, Norway, Poland, Russia, Spain, Sweden, Switzerland, Ukraine, United Kingdom, United States
Outcome results
None listed