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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
309
Pfizer Investigational Site
Beijing, China
Pfizer Investigational Site
Cheng Du Si Chaun, China
Pfizer Investigational Site
Guangzhou, China
Pfizer Investigational Site
Nan Jing, Jiang Su, China
The primary efficacy parameter is the endpoint mean pain score based on the pain scores from the subject's daily pain diaries.
The secondary efficacy parameters include the weekly mean pain scores from the subject's daily pain diaries
The Short Form McGill Pain Questionnaire
The Sleep interference score (from subject pain diary)
The Clinician and Patient Global Impression of Change (CGIC and PGIC)
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.
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Pfizer Investigational Site
Qing Dao Shan Dong, China
Pfizer Investigational Site
Shanghai, China
Pfizer Investigational Site
Tianjin, China