Pregabalin Trial In HIV Neuropathic Pain

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01145417
First received: June 7, 2010
Last updated: May 7, 2013
Last verified: May 2013
Results First Received: May 7, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV-1 Infection
Neuropathic Pain
Intervention: Drug: pregabalin (Lyrica)

  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
Following completion of Visit 9 (Day 57) of double-blind trial A0081244 (NCT01049217), participants who met eligibility criteria initiated open-label treatment in the current trial A0081251 (NCT01145417).

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-Pregabalin Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
Placebo-Pregabalin Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.

Participant Flow:   Overall Study
    Pregabalin-Pregabalin     Placebo-Pregabalin  
STARTED     108     109  
COMPLETED     67     62  
NOT COMPLETED     41     47  
Death                 1                 0  
Lost to Follow-up                 2                 1  
Withdrawal by Subject                 1                 2  
Pregnancy                 1                 0  
Adverse Event                 0                 1  
Study terminated by sponsor                 35                 43  
Unspecified                 1                 0  



  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-Pregabalin Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
Placebo-Pregabalin Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
Total Total of all reporting groups

Baseline Measures
    Pregabalin-Pregabalin     Placebo-Pregabalin     Total  
Number of Participants  
[units: participants]
  108     109     217  
Age  
[units: years]
Mean ± Standard Deviation
  42.4  ± 8.8     43.5  ± 7.9     42.9  ± 8.4  
Gender  
[units: participants]
     
Female     71     68     139  
Male     37     41     78  



  Outcome Measures
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1.  Primary:   Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to 30 days after last dose of study treatment ]

2.  Secondary:   Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire   [ Time Frame: Baseline, Week 24 ]

3.  Secondary:   Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire   [ Time Frame: Baseline, Week 24 ]

4.  Secondary:   Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire   [ Time Frame: Baseline, Week 24 ]

5.  Secondary:   36-Item Short-Form Health Survey (SF-36)   [ Time Frame: Baseline, Week 24 ]

6.  Secondary:   Visual Analogue Scale for Pain (VAS-pain)   [ Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24 ]

7.  Secondary:   Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)   [ Time Frame: Week 24 ]

8.  Secondary:   Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories   [ Time Frame: Baseline up to Week 25 ]

9.  Secondary:   Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)   [ Time Frame: Baseline ]


  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
The parent double blind trial A0081244 (NCT01049217) was stopped at interim analysis due to lack of efficacy and therefore this open label extension study was also terminated.


  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.


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


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01145417     History of Changes
Other Study ID Numbers: A0081251
Study First Received: June 7, 2010
Results First Received: May 7, 2013
Last Updated: May 7, 2013
Health Authority: United States: Food and Drug Administration