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A Study to Assess the Efficacy, Safety and Tolerability of Pregabalin in Patients With Symptoms of Neuropathic Pain

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00301223
First received: March 7, 2006
Last updated: May 4, 2011
Last verified: May 2011
History of Changes

March 7, 2006
May 4, 2011
February 2006
Not Provided
The primary efficacy parameter is the endpoint mean pain score based on the pain scores from the subject's daily pain diaries.
To evaluate the efficacy of pregabalin
Complete list of historical versions of study NCT00301223 on ClinicalTrials.gov Archive Site
  • 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.
To evaluate the safety and efficacy of pregabalin
Not Provided
Not Provided
 
A Study to Assess the Efficacy, Safety and Tolerability of Pregabalin in Patients With Symptoms of Neuropathic Pain
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Neuropathic Pain
Drug: Pregabalin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
309
September 2007
Not Provided

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00301223
A0081081
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP