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Open Label Safety And Efficacy Study Of Pregabalin In Subjects With Nerve Pain Asociated With Human Immunodeficiency Virus (HIV) Neuropathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00264875
First Posted: December 13, 2005
Last Update Posted: July 29, 2009
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.
Information provided by:
Pfizer
Results First Submitted: February 20, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Peripheral Neuropathy
HIV Infections
Intervention: Drug: pregabalin

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Pregabalin Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs).

Baseline Measures
   Pregabalin 
Overall Participants Analyzed 
[Units: Participants]
 220 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.3  (7.8) 
Gender 
[Units: Participants]
 
Female   42 
Male   178 


  Outcome Measures

1.  Primary:   Mean Visual Analogue Scale (VAS) Pain Scores   [ Time Frame: Baseline, Week 4, Week 8, Week 12, and Endpoint ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information