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Trial record 1 of 1 for:    NCT00301223
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A Study to Assess the Efficacy, Safety and Tolerability of Pregabalin in Patients With Symptoms of Neuropathic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00301223
Recruitment Status : Completed
First Posted : March 10, 2006
Last Update Posted : May 5, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 7, 2006
First Posted Date  ICMJE March 10, 2006
Last Update Posted Date May 5, 2011
Study Start Date  ICMJE February 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2006)
The primary efficacy parameter is the endpoint mean pain score based on the pain scores from the subject's daily pain diaries.
Original Primary Outcome Measures  ICMJE
 (submitted: March 9, 2006)
To evaluate the efficacy of pregabalin
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2006)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2006)
To evaluate the safety and efficacy of pregabalin
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Efficacy, Safety and Tolerability of Pregabalin in Patients With Symptoms of Neuropathic Pain
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Neuropathic Pain
Intervention  ICMJE Drug: Pregabalin
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 4, 2011)
309
Original Enrollment  ICMJE
 (submitted: March 9, 2006)
240
Actual Study Completion Date  ICMJE September 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00301223
Other Study ID Numbers  ICMJE A0081081
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2011

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