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

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ClinicalTrials.gov Identifier: NCT00264875
Recruitment Status : Completed
First Posted : December 13, 2005
Results First Posted : March 23, 2009
Last Update Posted : April 2, 2009
Sponsor:
Information provided by:
Pfizer

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

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

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 
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 ]
  Show Outcome Measure 1


  Serious Adverse Events


  Other Adverse Events

Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   >2%  

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).

Other Adverse Events
    Pregabalin
Total, Other (not including serious) Adverse Events   
# participants affected   82 
Gastrointestinal disorders   
Diarrhea † 1   
# participants affected / at risk   12/220 (5.45%) 
Dry mouth † 1   
# participants affected / at risk   7/220 (3.18%) 
Vomiting † 1   
# participants affected / at risk   7/220 (3.18%) 
Nausea † 1   
# participants affected / at risk   6/220 (2.73%) 
General disorders   
Peripheral edema † 1   
# participants affected / at risk   13/220 (5.91%) 
Fatigue † 1   
# participants affected / at risk   11/220 (5.00%) 
Infections and infestations   
Upper respiratory tract infection † 1   
# participants affected / at risk   5/220 (2.27%) 
Musculoskeletal and connective tissue disorders   
Pain in extremity † 1   
# participants affected / at risk   7/220 (3.18%) 
Back pain † 1   
# participants affected / at risk   6/220 (2.73%) 
Nervous system disorders   
Dizziness † 1   
# participants affected / at risk   22/220 (10.00%) 
Somnolence † 1   
# participants affected / at risk   21/220 (9.55%) 
Headache † 1   
# participants affected / at risk   8/220 (3.64%) 
Psychiatric disorders   
Euphoric mood † 1   
# participants affected / at risk   8/220 (3.64%) 
Respiratory, thoracic and mediastinal disorders   
Cough † 1   
# participants affected / at risk   7/220 (3.18%) 
Pharyngolaryngeal pain † 1   
# participants affected / at risk   5/220 (2.27%) 
Skin and subcutaneous tissue disorders   
Rash † 1   
# participants affected / at risk   5/220 (2.27%) 
† Events were collected by systematic assessment
1 Term from vocabulary, MedDRA v11.0



  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
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  More Information