Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01049217
First received: January 13, 2010
Last updated: August 27, 2013
Last verified: August 2013
Results First Received: May 6, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All participants received placebo matched to pregabalin capsule orally twice daily for 2 weeks in placebo lead-in phase prior to randomization.

Reporting Groups
  Description
Pregabalin Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Placebo Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.

Participant Flow:   Overall Study
    Pregabalin     Placebo  
STARTED     183     194  
Treated     183     192  
COMPLETED     127     131  
NOT COMPLETED     56     63  
Adverse Event                 2                 1  
Lack of Efficacy                 1                 1  
Lost to Follow-up                 3                 8  
Withdrawal by Subject                 4                 3  
Protocol Violation                 1                 3  
Pregnancy                 1                 0  
Study Terminated by Sponsor                 43                 43  
Unspecified                 1                 2  
Randomized but not Treated                 0                 2  



  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 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Placebo Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Total Total of all reporting groups

Baseline Measures
    Pregabalin     Placebo     Total  
Number of Participants  
[units: participants]
  183     192     375  
Age  
[units: years]
Mean ± Standard Deviation
  41.2  ± 9.0     42.3  ± 8.4     41.7  ± 8.7  
Gender  
[units: participants]
     
Female     121     116     237  
Male     62     76     138  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Mean Pain Score at Endpoint (up to Week 16)   [ Time Frame: Baseline, Endpoint (up to Week 16) ]

2.  Secondary:   Number of Participants With Categorical Scores on Patient Global Impression of Change (PGIC)   [ Time Frame: Week 16 ]

3.  Secondary:   Number of Participants With Categorical Scores on Clinician Global Impression of Change (CGIC)   [ Time Frame: Week 16 ]

4.  Secondary:   Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16)   [ Time Frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, Endpoint (up to Week 16) ]

5.  Secondary:   Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16)   [ Time Frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, Endpoint (up to Week 16) ]

6.  Secondary:   Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score at Week 4, 8, 12, 16 and Endpoint (up to Week 16)   [ Time Frame: Baseline, Week 4, 8, 12, 16, Endpoint (up to Week 16) ]

7.  Secondary:   Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16)   [ Time Frame: Baseline, Endpoint (up to Week 16) ]

8.  Secondary:   Neuropathic Pain Symptom Inventory (NPSI): Change From Baseline in Number of Participants With Duration of Spontaneous Pain and Number of Pain Attacks at Endpoint (up to Week 16)   [ Time Frame: Baseline, Endpoint (up to Week 16) ]

9.  Secondary:   Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Subscales and Total Intensity Score at Endpoint (up to Week 16)   [ Time Frame: Baseline, Endpoint (up to Week 16) ]

10.  Secondary:   Total Sleep Time (TST) and Minutes of Interrupted Sleep (MIS)   [ Time Frame: Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16) ]

11.  Secondary:   Sleep Fragmentation Index (SFI)   [ Time Frame: Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16) ]

12.  Secondary:   Sleep Efficiency   [ Time Frame: Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16) ]

13.  Secondary:   Total Activity Counts   [ Time Frame: Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16) ]

14.  Secondary:   Percentage Day Time Above Sedentary Level   [ Time Frame: Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16) ]

15.  Secondary:   Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Endpoint (up to Week 16)   [ Time Frame: Baseline, Endpoint (up to Week 16) ]

16.  Secondary:   Medical Outcomes Study-Sleep Scale (MOS-SS): Number of Participants With Optimal Sleep   [ Time Frame: Baseline, Endpoint (up to Week 16) ]

17.  Secondary:   Change From Baseline in Hospital Anxiety and Depression Scales (HADS) at Endpoint (up to Week 16)   [ Time Frame: Baseline, Endpoint (up to Week 16) ]

18.  Secondary:   Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Endpoint (up to Week 16)   [ Time Frame: Baseline, Endpoint (up to Week 16) ]

19.  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 16, 17 ]

20.  Secondary:   Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire   [ Time Frame: Baseline, Week 16, 17 ]

21.  Secondary:   Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire   [ Time Frame: Baseline, Week 16, 17 ]

22.  Secondary:   Diagnostic Neuropathy Assessment   [ Time Frame: Screening ]

23.  Other Pre-specified:   Number of Participants With Treatment-Emergent (TE) Adverse Events (AEs) or Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to 28 days after last dose ]

24.  Other Pre-specified:   Number of Participants With Abnormal Laboratory Test Findings   [ Time Frame: Screening up to Week 17 ]

25.  Other Pre-specified:   Number of Participants With Positive Serum and Urine Pregnancy   [ Time Frame: Screening for serum pregnancy test, Week 1 for urine pregnancy test ]

26.  Other Pre-specified:   Number of Participants With Abnormal Physical Examination Findings   [ Time Frame: Screening, Week 8, 17 ]

27.  Other Pre-specified:   Body Weight   [ Time Frame: Screening, Week 1, 4, 8, 12, 16, 17 ]

28.  Other Pre-specified:   Sitting Systolic and Diastolic Blood Pressure   [ Time Frame: Screening, Week 1, 4, 8, 12, 16, 17 ]

29.  Other Pre-specified:   Sitting Heart Rate   [ Time Frame: Screening, Week 1, 4, 8, 12, 16, 17 ]

30.  Other Pre-specified:   Number of Participants With Neurological Examination Findings   [ Time Frame: Screening ]

31.  Other Pre-specified:   Number of Participants Who Met Mini-International Neuropsychiatric Interview (MINI) Criteria   [ Time Frame: Screening ]

32.  Other Pre-specified:   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: Screening, Post-Baseline (Week 4 up to Week 17) ]

33.  Other Pre-specified:   Number of Participants With Response to Patient Health Questionnaire–8 (PHQ-8)   [ Time Frame: Screening ]


  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
Based on Data Monitoring Committee (DMC) interim efficacy analysis results indicating a low probability for success, the study was terminated on April 2, 2012; the termination was unrelated to any safety findings that could impact participant health.  


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: NCT01049217     History of Changes
Other Study ID Numbers: A0081244
Study First Received: January 13, 2010
Results First Received: May 6, 2013
Last Updated: August 27, 2013
Health Authority: United States: Food and Drug Administration