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Trial record 1 of 1 for:    NCT00232141
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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 : August 11, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE September 30, 2005
First Posted Date  ICMJE October 4, 2005
Results First Submitted Date  ICMJE November 25, 2008
Results First Posted Date  ICMJE August 11, 2009
Last Update Posted Date August 11, 2009
Study Start Date  ICMJE October 2005
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2009)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: September 30, 2005)
Comparison of change in mean weekly pain score from baseline to end of study as measured on a daily pain diary on a 11-point rating scale.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2009)
  • 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.
  • 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).
  • 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)
  • 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])
  • 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).
  • 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).
  • 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
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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)
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2005)
Proportion of subjects experiencing 30 and 50% reduction in pain at endpoint (responder rates); weekly mean pain scores; patient global impression of change; MOS-Sleep Scale; Hospital Anxiety and Depression Scale; Gracely Pain Scale; Brief Pain Inventory
Current Other Pre-specified Outcome Measures
 (submitted: June 22, 2009)
  • 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)
  • 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.
  • 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.
  • 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).
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Pregabalin Versus Placebo in the Treatment of Nerve Pain Associated With HIV Neuropathy
Official Title  ICMJE 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.
Brief Summary Study to determine if pregabalin is more effective than placebo in treating subjects with nerve pain associated with HIV neuropathy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV Infections
  • Peripheral Neuropathy
Intervention  ICMJE
  • 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)
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: pregabalin
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2009)
302
Original Enrollment  ICMJE
 (submitted: September 30, 2005)
300
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00232141
Other Study ID Numbers  ICMJE A0081066
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP