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Trial record 1 of 1 for:    NCT00424372
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A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Postherpetic Neuralgia

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: NCT00424372
Recruitment Status : Completed
First Posted : January 19, 2007
Results First Posted : September 28, 2009
Last Update Posted : November 11, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE January 18, 2007
First Posted Date  ICMJE January 19, 2007
Results First Submitted Date  ICMJE August 19, 2009
Results First Posted Date  ICMJE September 28, 2009
Last Update Posted Date November 11, 2009
Study Start Date  ICMJE January 2007
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2009)
Summary of Adverse Events [ Time Frame: 52 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 18, 2007)
Safety
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2009)
  • Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score [ Time Frame: 52 weeks ]
  • Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score [ Time Frame: 52 weeks ]
  • Short-Form McGill Pain Questionnaire the Efficacy of Change: Total Score [ Time Frame: 52 weeks ]
  • Short-Form McGill Pain Questionnaire the Efficacy of Change: Present Pain Intensity [ Time Frame: 52 weeks ]
  • Short-Form McGill Pain Questionnaire the Efficacy of Change: Visual Analog Scale [ Time Frame: 52 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2007)
Short-Form McGill Pain Questionnaire the efficacy of Change
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Postherpetic Neuralgia
Official Title  ICMJE A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin In The Treatment Of Postherpetic Neuralgia
Brief Summary To evaluate the safety of the long-term use of pregabalin.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuralgia, Postherpetic
Intervention  ICMJE Drug: pregabalin
Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks
Study Arms  ICMJE Experimental: pregabalin
Intervention: Drug: pregabalin
Publications * Not Provided

*   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: September 24, 2008)
126
Original Enrollment  ICMJE
 (submitted: January 18, 2007)
150
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients who completed the 13-week treatment of postherpetic neuralgia in Study A0081120.
  • Patients must be able to understand and cooperate with study procedures and have signed a written informed consent prior to entering the study.

Exclusion Criteria:

  • Patients who experienced serious adverse events in the preceding study (A0081120) that were determined by the investigator or the study sponsor to be causally related to the study medication.
  • Patients exhibiting treatment non-compliance in the preceding study (A0081120)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00424372
Other Study ID Numbers  ICMJE A0081121
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2009

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