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

September 30, 2005
June 22, 2009
October 2005
November 2007   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00232141 on ClinicalTrials.gov Archive Site
  • Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices [ Time Frame: Baseline, Week 14 ] [ Designated as safety issue: No ]
  • Change From Baseline for Hospital Anxiety and Depression Scale (HADS) Subscales [ Time Frame: Baseline, Week 14 ] [ Designated as safety issue: No ]
  • Change From Baseline for Modified Brief Pain Inventory-Short Form (mBPI-sf) Scores [ Time Frame: Baseline, Week 14 ] [ Designated as safety issue: No ]
  • Change From Baseline for NRS-Sleep Interference Scores [ Time Frame: Baseline, Week 14 ] [ Designated as safety issue: No ]
  • Categorized Patient Global Impression of Change (PGIC) [ Time Frame: Baseline, Week 14 ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change (PGIC) Rating [ Time Frame: Baseline, Week 14, Endpoint-LOCF ] [ Designated as safety issue: No ]
  • Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores [ Time Frame: Baseline, Week 14 ] [ Designated as safety issue: No ]
  • Change in Quantitative Assessment of Neuropathic Pain (QANeP) [ Time Frame: Baseline, Week 14 ] [ Designated as safety issue: No ]
  • Change in NRS-Sleep Interference Scores [ Time Frame: Baseline, Weeks 1-14 ] [ Designated as safety issue: No ]
  • Shift in Hospital Anxiety and Depression (HADS) Subscales [ Time Frame: Baseline, Week 14 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain [ Time Frame: Baseline-Week 14 (Endpoint) ] [ Designated as safety issue: No ]
  • Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks [ Time Frame: Baseline-Week 14 (Endpoint) ] [ Designated as safety issue: No ]
  • Change in Number of Pain Attacks Compared to Baseline - NPSI (Neuropathic Pain Symptom Inventory) [ Time Frame: Baseline, Week 14 ] [ Designated as safety issue: No ]
  • Duration of Spontaneous Pain-NPSI (Neuropathic Pain Symptom Inventory) [ Time Frame: Baseline, Week 14 ] [ Designated as safety issue: No ]
  • Gracely Pain Scale Score [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
  • Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table [ Time Frame: Baseline-Week 14 (Endpoint) ] [ Designated as safety issue: No ]
  • Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table [ Time Frame: Baseline-Week 14 (Endpoint) ] [ Designated as safety issue: No ]
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
Not Provided
Not Provided
 
Study of Pregabalin Versus Placebo in the Treatment of Nerve Pain Associated With HIV Neuropathy
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 to determine if pregabalin is more effective than placebo in treating subjects with nerve pain associated with HIV neuropathy.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • HIV Infections
  • Peripheral Neuropathy
  • 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
  • Experimental: 1
    Intervention: Drug: pregabalin
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
302
November 2007
November 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00232141
A0081066
No
Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2009

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