Neuropathic Pain
Conditions
Brief summary
The objective of this study is to evaluate the efficacy, safety and tolerability for pregabalin using a flexible, optimized dose schedule compared to placebo in relieving the symptoms of neuropathic pain.
Interventions
DRUGPregabalin
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Chinese outpatient of age 18 to 75 * At screening and baseline, a score of greater than 40 mm on the visual log scale of SF-MPQ
Exclusion criteria
* Neurologic disorders unrelated to neuropathic pain, which in the opinion of the investigator, might impair the assessment of pain * Serum creatinine clearance greater than 60 ml/min
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy parameter is the endpoint mean pain score based on the pain scores from the subject's daily pain diaries. | — |
Secondary
| Measure | Time frame |
|---|---|
| The Short Form McGill Pain Questionnaire | — |
| The Sleep interference score (from subject pain diary) | — |
| The secondary efficacy parameters include the weekly mean pain scores from the subject's daily pain diaries | — |
| The responder rate defined as the proportion of subjects reporting a decrease of at least 30% in the weekly mean pain scores in each treatment group. | — |
| Addtionally, the safety and tolerability of Pregabalin will also be evaluated. | — |
| The Clinician and Patient Global Impression of Change (CGIC and PGIC) | — |
Countries
China
Outcome results
None listed