Study of Pregabalin Versus Placebo in the Treatment of Nerve Pain Associated With HIV Neuropathy

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00232141
First received: September 30, 2005
Last updated: June 22, 2009
Last verified: June 2009
Results First Received: November 25, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV Infections
Peripheral Neuropathy
Interventions: Drug: pregabalin
Drug: Placebo

  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
43 centers in the United States; Study Initiation and Completion Dates: 6 October 2005 to 27 November 2007

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 472 subjects were screened for the study, and 302 subjects were randomized to study treatment.

Reporting Groups
  Description
Pregabalin Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
Placebo Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.

Participant Flow:   Overall Study
    Pregabalin     Placebo  
STARTED     151     151  
COMPLETED     120     125  
NOT COMPLETED     31     26  
Adverse Event                 9                 4  
Lack of Efficacy                 0                 3  
Lost to Follow-up                 9                 6  
Unknown                 8                 10  
Withdrawal by Subject                 5                 3  



  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 Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
Placebo Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Total Total of all reporting groups

Baseline Measures
    Pregabalin     Placebo     Total  
Number of Participants  
[units: participants]
  151     151     302  
Age  
[units: years]
Mean ± Standard Deviation
  48.2  ± 8.1     46.8  ± 7.5     47.5  ± 7.8  
Gender  
[units: participants]
     
Female     26     31     57  
Male     125     120     245  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline   [ Time Frame: Baseline, Week 14 ]

2.  Secondary:   Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices   [ Time Frame: Baseline, Week 14 ]

3.  Secondary:   Change From Baseline for Hospital Anxiety and Depression Scale (HADS) Subscales   [ Time Frame: Baseline, Week 14 ]

4.  Secondary:   Change From Baseline for Modified Brief Pain Inventory-Short Form (mBPI-sf) Scores   [ Time Frame: Baseline, Week 14 ]

5.  Secondary:   Change From Baseline for NRS-Sleep Interference Scores   [ Time Frame: Baseline, Week 14 ]

6.  Secondary:   Categorized Patient Global Impression of Change (PGIC)   [ Time Frame: Baseline, Week 14 ]

7.  Secondary:   Patient Global Impression of Change (PGIC) Rating   [ Time Frame: Baseline, Week 14, Endpoint-LOCF ]

8.  Secondary:   Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores   [ Time Frame: Baseline, Week 14 ]

9.  Secondary:   Change in Quantitative Assessment of Neuropathic Pain (QANeP)   [ Time Frame: Baseline, Week 14 ]

10.  Secondary:   Change in NRS-Sleep Interference Scores   [ Time Frame: Baseline, Weeks 1-14 ]

11.  Secondary:   Shift in Hospital Anxiety and Depression (HADS) Subscales   [ Time Frame: Baseline, Week 14 ]

12.  Secondary:   Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours)   [ Time Frame: Baseline, Weeks 1,2,6,10,14, Endpoint - LOCF ]

13.  Secondary:   Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours)   [ Time Frame: Baseline, Weeks 1,2,6,10,14, Endpoint-LOCF ]

14.  Secondary:   Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours)   [ Time Frame: Baseline, Weeks 1,2,6,10,14 and Endpoint ]

15.  Secondary:   Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now)   [ Time Frame: Baseline, Weeks 1,2,6,10,14 and Endpoint ]

16.  Secondary:   Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity)   [ Time Frame: Baseline, Weeks 1,2,6,10,14 and Endpoint ]

17.  Secondary:   Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood)   [ Time Frame: Baseline, Weeks 1,2,6,10,14 and Endpoint ]

18.  Secondary:   Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability)   [ Time Frame: Baseline, Weeks 1,2,6,10,14 and Endpoint ]

19.  Secondary:   Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Normal Work Including Both Work Outside the Home and Housework)   [ Time Frame: Baseline, Weeks 1,2,6,10,14 and Endpoint ]

20.  Secondary:   Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People)   [ Time Frame: Baseline, Weeks 1,2,6,10,14 and Endpoint ]

21.  Secondary:   Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep)   [ Time Frame: Baseline, Weeks 1,2,6,10,14 and Endpoint ]

22.  Secondary:   Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life)   [ Time Frame: Baseline, Weeks 1,2,6,10,14 and Endpoint ]

23.  Secondary:   Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain   [ Time Frame: Baseline-Week 14 (Endpoint) ]

24.  Secondary:   Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks   [ Time Frame: Baseline-Week 14 (Endpoint) ]

25.  Secondary:   Change in Number of Pain Attacks Compared to Baseline - NPSI (Neuropathic Pain Symptom Inventory)   [ Time Frame: Baseline, Week 14 ]

26.  Secondary:   Duration of Spontaneous Pain-NPSI (Neuropathic Pain Symptom Inventory)   [ Time Frame: Baseline, Week 14 ]

27.  Secondary:   Gracely Pain Scale Score   [ Time Frame: Week 14 ]

28.  Secondary:   Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table   [ Time Frame: Baseline-Week 14 (Endpoint) ]

29.  Secondary:   Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table   [ Time Frame: Baseline-Week 14 (Endpoint) ]

30.  Other Pre-specified:   Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward)   [ Time Frame: Baseline, Weeks 1 - 14 and Endpoint-BOCF ]

31.  Other Pre-specified:   Responders- Decreases of at Least 50% in Mean Weekly Pain Score   [ Time Frame: Weeks 1-14 Endpoint BOCF (modified baseline observation carried forward) ]

32.  Other Pre-specified:   Responders - Decreases of at Least 30% in Mean Weekly Pain Score   [ Time Frame: Weeks 1-14 endpoint BOCF ]

33.  Other Pre-specified:   Duration Adjusted Average Change From Baseline in NRS Pain Scores   [ Time Frame: Weekly: Week 1 - Week 14 ]


  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: NCT00232141     History of Changes
Other Study ID Numbers: A0081066
Study First Received: September 30, 2005
Results First Received: November 25, 2008
Last Updated: June 22, 2009
Health Authority: United States: Food and Drug Administration