A Study to Assess the Efficacy, Safety and Tolerability of Pregabalin in Patients With Symptoms of Neuropathic Pain
Phase 3
Completed
- Conditions
- Neuropathic Pain
- Registration Number
- NCT00301223
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 309
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary efficacy parameter is the endpoint mean pain score based on the pain scores from the subject's daily pain diaries.
- Secondary Outcome Measures
Name Time Method 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. The Sleep interference score (from subject pain diary) The Clinician and Patient Global Impression of Change (CGIC and PGIC) Addtionally, the safety and tolerability of Pregabalin will also be evaluated. The Short Form McGill Pain Questionnaire
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which pregabalin modulates neuropathic pain pathways in clinical trials?
How does pregabalin's efficacy in neuropathic pain compare to other anticonvulsants like gabapentin or carbamazepine?
Are there specific biomarkers associated with improved response to pregabalin in patients with diabetic neuropathy or postherpetic neuralgia?
What are the most common adverse events reported in phase 3 trials of pregabalin for neuropathic pain and how are they managed?
How do pregabalin's pharmacokinetic properties influence its use in combination with opioids for neuropathic pain management?
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇨🇳Tian Jin, China
Pfizer Investigational Site🇨🇳Tian Jin, China