Pain
Conditions
Brief summary
The purpose of this study is to determine the effectiveness of PD-217,014 in the treatment of chronic pain following a shingles infection.
Interventions
DRUGPD-217,014
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 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 |
|---|---|
| To characterise the effectiveness of PD-217,014 in the treatment of chronic pain. A numerical pain intensity rating scale is used to assess pain and a mean endpoint (week 4) pain score change from baseline is calculated. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Assess the effect of PD-217,014 on responder rate based on the primary endpoint, mean endpoint sleep interference score and the SF-McGill questionnaire (change from baseline to week 4) | — |
Countries
Australia, Canada, Czechia, Netherlands, Spain, United Kingdom
Outcome results
None listed