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A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Postherpetic Neuralgia

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00424372
First received: January 18, 2007
Last updated: October 30, 2009
Last verified: October 2009
History of Changes
Results First Received: August 19, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Neuralgia, Postherpetic
Intervention: Drug: pregabalin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 126 subjects who completed the 13-week treatment regimen in the preceding double-blind Study A0081120 and had no serious adverse events or issues with compliance were enrolled to this study.

Reporting Groups
  Description
Pregabalin Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).

Participant Flow:   Overall Study
    Pregabalin  
STARTED     126  
COMPLETED     95  
NOT COMPLETED     31  
Death                 1  
Adverse Event                 18  
Health deterioration                 1  
Withdrawal by Subject                 4  
Protocol Violation                 1  
Lack of Efficacy                 6  



  Baseline Characteristics
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Reporting Groups
  Description
Pregabalin Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).

Baseline Measures
    Pregabalin  
Number of Participants  
[units: participants]
 		  126  
Age, Customized  
[units: Subjects]
 		 
>= 18 and < 45 years     1  
>= 45 and < 65 years     19  
>=65 years     106  
Gender  
[units: Subjects]
 		 
Female     55  
Male     71  



  Outcome Measures
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1.  Primary:   Summary of Adverse Events   [ Time Frame: 52 weeks ]
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2.  Secondary:   Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score   [ Time Frame: 52 weeks ]
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3.  Secondary:   Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score   [ Time Frame: 52 weeks ]
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4.  Secondary:   Short-Form McGill Pain Questionnaire the Efficacy of Change: Total Score   [ Time Frame: 52 weeks ]
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5.  Secondary:   Short-Form McGill Pain Questionnaire the Efficacy of Change: Present Pain Intensity   [ Time Frame: 52 weeks ]
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6.  Secondary:   Short-Form McGill Pain Questionnaire the Efficacy of Change: Visual Analog Scale   [ Time Frame: 52 weeks ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com


No publications provided


Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00424372     History of Changes
Other Study ID Numbers: A0081121
Study First Received: January 18, 2007
Results First Received: August 19, 2009
Last Updated: October 30, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare