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
  Purpose

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


Condition Intervention Phase
HIV Infections
Peripheral Neuropathy
Drug: pregabalin
Drug: Placebo
Phase 3

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
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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 302
Study Start Date: October 2005
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232141

  Show 44 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Peripheral Nervous System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Neuromuscular Diseases
Nervous System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on October 16, 2014