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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00264875
First received: December 12, 2005
Last updated: March 20, 2009
Last verified: March 2009
Results First Received: February 20, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Peripheral Neuropathy
HIV Infections
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
With completion of A0081066 (NCT00232141), subjects had option of initiating treatment with pregabalin under open-label conditions for 3 months in A0081095, an open-label extension trial. Treatment in A0081095 was initiated on the evening of the subjects’ Visit 7/Termination Visit in A0081066. A0081095 was conducted in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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).

Participant Flow:   Overall Study
    Pregabalin  
STARTED     220  
COMPLETED     190  
NOT COMPLETED     30  
Adverse Event                 6  
Lost to Follow-up                 6  
Protocol Violation                 11  
Withdrawal by Subject                 7  



  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.
No text entered.

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  
Number of Participants  
[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 ]
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Measure Type Primary
Measure Title Mean Visual Analogue Scale (VAS) Pain Scores
Measure Description

Pain scores were assessed on a 100 mm Visual Analogue Scale (VAS); scores range from 0= no pain to 100= worse pain. Subjects assessed their pain during the last week.

Endpoint = last non-missing observation carried forward after Baseline visit.

Time Frame Baseline, Week 4, Week 8, Week 12, and Endpoint  
Safety Issue No  

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.
The full analysis set was defined as all subjects who met all eligibility criteria and took at least one dose of study medication.

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).

Measured Values
    Pregabalin  
Number of Participants Analyzed  
[units: participants]
  220  
Mean Visual Analogue Scale (VAS) Pain Scores  
[units: scoreĀ onĀ scale]
Mean ± Standard Deviation
 
Baseline (n=203)     38.61  ± 27.10  
Week 4 (n=204)     30.75  ± 25.19  
Week 8 (n=200)     30.16  ± 25.78  
Week 12 (n=207)     28.95  ± 26.05  
Endpoint (n=217)     29.39  ± 26.32  

No statistical analysis provided for Mean Visual Analogue Scale (VAS) Pain Scores




  Serious Adverse Events


  Other Adverse Events


  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: NCT00264875     History of Changes
Other Study ID Numbers: A0081095
Study First Received: December 12, 2005
Results First Received: February 20, 2009
Last Updated: March 20, 2009
Health Authority: United States: Food and Drug Administration