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
  Purpose

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.


Condition Intervention Phase
Neuropathic Pain
Drug: Pregabalin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 309
Study Start Date: February 2006
Study Completion Date: September 2007
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301223

Locations
China
Pfizer Investigational Site
Beijing, China
Pfizer Investigational Site
Cheng Du Si Chaun, China
Pfizer Investigational Site
Guang Zhou, China
Pfizer Investigational Site
Nan Jing, Jiang Su, China
Pfizer Investigational Site
Qing Dao Shan Dong, China
Pfizer Investigational Site
Shang Hai, China
Pfizer Investigational Site
Shanghai, China
Pfizer Investigational Site
Tian Jin, China
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00301223     History of Changes
Other Study ID Numbers: A0081081
Study First Received: March 7, 2006
Last Updated: May 4, 2011
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on July 24, 2014