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

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ClinicalTrials.gov Identifier: NCT00232141
Recruitment Status : Completed
First Posted : October 4, 2005
Results First Posted : August 11, 2009
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Brief Summary:
Study to determine if pregabalin is more effective than placebo in treating subjects with nerve pain associated with HIV neuropathy.

Condition or disease Intervention/treatment Phase
HIV Infections Peripheral Neuropathy Drug: pregabalin Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial of Pregabalin Versus Placebo in the Treatment of Neuropathic Pain Associated With HIV Neuropathy.
Study Start Date : October 2005
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Pregabalin

Arm Intervention/treatment
Experimental: 1 Drug: pregabalin
75mg BID (can be titrated up to 150mg BID on day 4 based on individual response and up to 300mg BID at the end of week 1, visit 3 and end of week 2, visit 4)

Placebo Comparator: 2 Drug: Placebo
Placebo




Primary Outcome Measures :
  1. 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 ]
    Change from baseline in mean NRS-Pain scores at endpoint-LOCF. Daily pain scores were assessed on an 11-point numerical rating scale <(NRS)-Pain> ranging from 0 (no pain) to 10 (worst possible pain).


Secondary Outcome Measures :
  1. Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices [ Time Frame: Baseline, Week 14 ]
    Change from baseline in MOS-Sleep subscales & Sleep Problem Indices. Twelve item subject-rated questionnaire assessing sleep constructs. Scores range from 0 - 100 and higher scores reflect more impairment. Subscales "sleep adequacy", "quantity of sleep" and "optimal sleep" low scores reflect impairment.

  2. Change From Baseline for Hospital Anxiety and Depression Scale (HADS) Subscales [ Time Frame: Baseline, Week 14 ]
    Change from Baseline in scale at endpoint: normal (score 0) to severe (score 21).

  3. Change From Baseline for Modified Brief Pain Inventory-Short Form (mBPI-sf) Scores [ Time Frame: Baseline, Week 14 ]
    Change from baseline to endpoint in the mBPI-sf to assess pain severity and pain interference with functional activities: 11-point scale ranging from "no pain" (0) to "pain as bad as you can imagine" (10)

  4. Change From Baseline for NRS-Sleep Interference Scores [ Time Frame: Baseline, Week 14 ]
    11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain])

  5. Categorized Patient Global Impression of Change (PGIC) [ Time Frame: Baseline, Week 14 ]
    The PGIC is a participant-rated instrument that measures change in the participants overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse). PGIC was evaluated using 3 categories of Improvement (Scores 1-3), No Change (Score 4), and Worsening (Scores 5-7).

  6. Patient Global Impression of Change (PGIC) Rating [ Time Frame: Baseline, Week 14, Endpoint-LOCF ]
    PGIC is a participant-rated instrument that measures change in the participants overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse).

  7. Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores [ Time Frame: Baseline, Week 14 ]
    Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. 10 pain descriptors questions answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). 2 items related to temporal pain assessed on 5-point scales. The NPSI derives 5 pain subscores & a total intensity score calculated from the 5 pain subscores

  8. Change in Quantitative Assessment of Neuropathic Pain (QANeP) [ Time Frame: Baseline, Week 14 ]
    Change in a quantitative assessment of the participants' neuropathic pain were on an 11-point scale ranging from 0 (no pain) to 10 (most intense pain imaginable).

  9. Change in NRS-Sleep Interference Scores [ Time Frame: Baseline, Weeks 1-14 ]
    Change in mean Pain-related sleep interference was assessed on an 11-point scale from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Weekly mean score was the sum of the daily diary scores divided by the number of diary entries during that week.

  10. Shift in Hospital Anxiety and Depression (HADS) Subscales [ Time Frame: Baseline, Week 14 ]
    Anxiety subscale analyzes generalized anxiety (anxious mood,restlessness, anxious thoughts, panic attacks). The depression subscale focuses on the state of lost interest and diminished pleasure response. A score of Normal = 0-7, Mild = 8-10, Moderate = 11-14, Severe = 15-21.

  11. 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 ]
    Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.

  12. 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 ]
    Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.

  13. 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 ]
    Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.

  14. 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 ]
    Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.

  15. 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 ]
    Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.

  16. 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 ]
    Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.

  17. 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 ]
    Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.

  18. 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 ]
    Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.

  19. 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 ]
    Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.

  20. 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 ]
    Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.

  21. 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 ]
    Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.

  22. Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain [ Time Frame: Baseline-Week 14 (Endpoint) ]
    Number of subjects reporting duration of spontaneous pain. The NPSI includes the temporal item for assessment of duration of spontaneous, ongoing and paroxysmal pain. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.

  23. Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks [ Time Frame: Baseline-Week 14 (Endpoint) ]
    Number of subjects reporting pain attacks. The NPSI includes the temporal item for assessing the numbers of pain attacks. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.

  24. Change in Number of Pain Attacks Compared to Baseline - NPSI (Neuropathic Pain Symptom Inventory) [ Time Frame: Baseline, Week 14 ]
    Change from baseline in the number of pain attacks at endpoint. The NPSI includes the temporal item for assessing the numbers of pain attacks. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.

  25. Duration of Spontaneous Pain-NPSI (Neuropathic Pain Symptom Inventory) [ Time Frame: Baseline, Week 14 ]
    Change from baseline to endpoint in the duration of spontaneous pain. The NPSI includes the temporal item for assessment of duration of spontaneous, ongoing and paroxysmal pain. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.

  26. Gracely Pain Scale Score [ Time Frame: Week 14 ]
    The modified Gracely Pain Scale is a 13-point verbal rating scale based on sensory pain descriptors ranked by severity from nothing (rank = 0) to extremely intense (rank = 15). Subjects selected the verbal descriptors that best matched their average neuropathic pain during the last 24 hours prior to assessment.

  27. Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table [ Time Frame: Baseline-Week 14 (Endpoint) ]
    Shift from baseline in maximum sensory thresholds (in grams representing the force equivalent of various sizes of von Frey filaments) as measured on QANeP. Improved - decrease in the maximum of the 3 trials at endpoint. Worsened - an increase. Note:Sensory Thresholds are the highest values of the 3 trials at baseline (Week=0) and endpoint (Week 14)

  28. Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table [ Time Frame: Baseline-Week 14 (Endpoint) ]
    Shift from baseline in median sensory thresholds (designated as Weight) from 3 trials as measured on the QANeP. Improved - a decrease in the median of the three trials at endpoint. Worsened - an increase. Note: Sensory Thresholds are the highest values of the three Trials at both baseline (Week=0) and endpoint (Week 14).


Other Outcome Measures:
  1. Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) [ Time Frame: Baseline, Weeks 1 - 14 and Endpoint-BOCF ]
    Change from baseline in mean NRS-Pain scores at endpoint-BOCF. Daily pain scores were assessed on an 11-point numerical rating scale <(NRS)-Pain> ranging from 0 (no pain) to 10 (worst possible pain). Change from baseline in mean weekly pain scores was analyzed using longitudinal models assuming data were missing at random (MAR)

  2. Responders- Decreases of at Least 50% in Mean Weekly Pain Score [ Time Frame: Weeks 1-14 Endpoint BOCF (modified baseline observation carried forward) ]
    Number of subjects that experienced at least a 50% decrease in mean weekly pain.

  3. Responders - Decreases of at Least 30% in Mean Weekly Pain Score [ Time Frame: Weeks 1-14 endpoint BOCF ]
    Number of subjects that experienced at least 30% decrease in mean weekly pain.

  4. Duration Adjusted Average Change From Baseline in NRS Pain Scores [ Time Frame: Weekly: Week 1 - Week 14 ]
    Duration Adjusted Average Change(DAAC) in NRS-Pain score = (mean at observation - mean at baseline)x(proportion of planned study duration that the subject completed).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with confirmed diagnosis of HIV infection
  • HIV-associated neuropathic pain (nerve pain) for at least 3 months prior to study start
  • subjects with moderate to severe pain
  • subjects on stable HIV and pain medications (some medications are not allowed to be taken while participating in the study).

Exclusion Criteria:

  • Pregnant or breast feeding females
  • subjects using street drugs or alcohol abusers during the study
  • subject's on anti-diabetic medications
  • use of neuroregenerative agents or neurotoxic chemotherapeutic agents 3 months prior to study start and throughout the study
  • use of neurotoxic drugs (other than D-drugs) within a month prior to study start and throughout the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00232141


Locations
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United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85023
United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72207
United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90025
Pfizer Investigational Site
Los Angeles, California, United States, 90028
Pfizer Investigational Site
Sacramento, California, United States, 95817-1460
Pfizer Investigational Site
San Diego, California, United States, 92103
Pfizer Investigational Site
San Francisco, California, United States, 94117
Pfizer Investigational Site
Stanford, California, United States, 94301
Pfizer Investigational Site
West Hollywood, California, United States, 90069
United States, Colorado
Pfizer Investigational Site
Denver, Colorado, United States, 80262
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33133
Pfizer Investigational Site
Pensacola, Florida, United States, 32504-5719
Pfizer Investigational Site
Safety Harbor, Florida, United States, 34695
Pfizer Investigational Site
Vero Beach, Florida, United States, 32960
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33407
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30309
United States, Hawaii
Pfizer Investigational Site
Honolulu, Hawaii, United States, 96816
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60611
Pfizer Investigational Site
Chicago, Illinois, United States, 60612
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21287-7609
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02215
Pfizer Investigational Site
Springfield, Massachusetts, United States, 01107
United States, Missouri
Pfizer Investigational Site
Saint Louis, Missouri, United States, 63110-1010
Pfizer Investigational Site
Saint Louis, Missouri, United States, 63110
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10018
Pfizer Investigational Site
New York, New York, United States, 10021
Pfizer Investigational Site
New York, New York, United States, 10029
Pfizer Investigational Site
Rochester, New York, United States, 14642
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97209
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78705
Pfizer Investigational Site
Dallas, Texas, United States, 75204
Pfizer Investigational Site
Dallas, Texas, United States, 75208-4234
Pfizer Investigational Site
Dallas, Texas, United States, 75208
Pfizer Investigational Site
Dallas, Texas, United States, 75219
Pfizer Investigational Site
Dallas, Texas, United States, 75390-9036
Pfizer Investigational Site
Longview, Texas, United States, 75605
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98104
United States, Wisconsin
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53226
Puerto Rico
Pfizer Investigational Site
Ponce, Puerto Rico, 00716
Pfizer Investigational Site
San Juan, Puerto Rico, 00909-1711
Pfizer Investigational Site
San Juan, Puerto Rico, 00936-0000
Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier: NCT00232141    
Other Study ID Numbers: A0081066
First Posted: October 4, 2005    Key Record Dates
Results First Posted: August 11, 2009
Last Update Posted: February 9, 2021
Last Verified: June 2009
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs