Clinical trial NCT00301223: A Study to Assess the Efficacy, Safety and Tolerability of Pregabalin in Patients With Symptoms of Neuropathic Pain
Official title: An 8-Week Multi-Center, Randomized, Double Blind, Placebo-Controlled Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin (150mg-600mg/Day) Using A Flexible Dosing Schedule In The Treatment Of Subjects With Symptoms Of Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neuropathic Pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-03-10
Enrollment: 309
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The primary efficacy parameter is the endpoint mean pain score based on the pain scores from the subject's daily pain diaries.
Secondary outcomes:
measure: The secondary efficacy parameters include the weekly mean pain scores from the subject's daily pain diaries
measure: The Short Form McGill Pain Questionnaire
measure: The Sleep interference score (from subject pain diary)
measure: The Clinician and Patient Global Impression of Change (CGIC and PGIC)
measure: 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.
measure: Addtionally, the safety and tolerability of Pregabalin will also be evaluated.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Cheng Du Si Chaun
country: China
facility: Pfizer Investigational Site
city: Guang Zhou
country: China
facility: Pfizer Investigational Site
city: Nan Jing, Jiang Su
country: China
facility: Pfizer Investigational Site
city: Qing Dao Shan Dong
country: China
facility: Pfizer Investigational Site
city: Shang Hai
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Tian Jin
country: China
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Schug SA, Parsons B, Almas M, Whalen E. Effect of Concomitant Pain Medications on Response to Pregabalin in Patients with Postherpetic Neuralgia or Spinal Cord Injury-Related Neuropathic Pain. Pain Physician. 2017 Jan-Feb;20(1):E53-E63.
citation: Markman JD, Jensen TS, Semel D, Li C, Parsons B, Behar R, Sadosky AB. Effects of Pregabalin in Patients with Neuropathic Pain Previously Treated with Gabapentin: A Pooled Analysis of Parallel-Group, Randomized, Placebo-controlled Clinical Trials. Pain Pract. 2017 Jul;17(6):718-728. doi: 10.1111/papr.12516. Epub 2016 Dec 1.