Clinical trial NCT00232141: Study of Pregabalin Versus Placebo in the Treatment of Nerve Pain Associated With HIV Neuropathy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Peripheral Neuropathy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-10-04
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline
timeFrame: Baseline, Week 14
Secondary outcomes:
measure: Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices
timeFrame: Baseline, Week 14
measure: Change From Baseline for Hospital Anxiety and Depression Scale (HADS) Subscales
timeFrame: Baseline, Week 14
measure: Change From Baseline for Modified Brief Pain Inventory-Short Form (mBPI-sf) Scores
timeFrame: Baseline, Week 14
measure: Change From Baseline for NRS-Sleep Interference Scores
timeFrame: Baseline, Week 14
measure: Categorized Patient Global Impression of Change (PGIC)
timeFrame: Baseline, Week 14
measure: Patient Global Impression of Change (PGIC) Rating
timeFrame: Baseline, Week 14, Endpoint-LOCF
measure: Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores
timeFrame: Baseline, Week 14
measure: Change in Quantitative Assessment of Neuropathic Pain (QANeP)
timeFrame: Baseline, Week 14
measure: Change in NRS-Sleep Interference Scores
timeFrame: Baseline, Weeks 1-14
measure: Shift in Hospital Anxiety and Depression (HADS) Subscales
timeFrame: Baseline, Week 14
measure: Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours)
timeFrame: Baseline, Weeks 1,2,6,10,14, Endpoint - LOCF
measure: Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours)
timeFrame: Baseline, Weeks 1,2,6,10,14, Endpoint-LOCF
measure: Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours)
timeFrame: Baseline, Weeks 1,2,6,10,14 and Endpoint
measure: Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now)
timeFrame: Baseline, Weeks 1,2,6,10,14 and Endpoint
measure: Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity)
timeFrame: Baseline, Weeks 1,2,6,10,14 and Endpoint
measure: Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood)
timeFrame: Baseline, Weeks 1,2,6,10,14 and Endpoint
measure: Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability)
timeFrame: Baseline, Weeks 1,2,6,10,14 and Endpoint
measure: 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)
timeFrame: Baseline, Weeks 1,2,6,10,14 and Endpoint
measure: Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People)
timeFrame: Baseline, Weeks 1,2,6,10,14 and Endpoint
measure: Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep)
timeFrame: Baseline, Weeks 1,2,6,10,14 and Endpoint
measure: Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life)
timeFrame: Baseline, Weeks 1,2,6,10,14 and Endpoint
measure: Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain
timeFrame: Baseline-Week 14 (Endpoint)
measure: Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks
timeFrame: Baseline-Week 14 (Endpoint)
measure: Change in Number of Pain Attacks Compared to Baseline - NPSI (Neuropathic Pain Symptom Inventory)
timeFrame: Baseline, Week 14
measure: Duration of Spontaneous Pain-NPSI (Neuropathic Pain Symptom Inventory)
timeFrame: Baseline, Week 14
measure: Gracely Pain Scale Score
timeFrame: Week 14
measure: Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table
timeFrame: Baseline-Week 14 (Endpoint)
measure: Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table
timeFrame: Baseline-Week 14 (Endpoint)
Other outcomes:
measure: Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward)
timeFrame: Baseline, Weeks 1 - 14 and Endpoint-BOCF
measure: Responders- Decreases of at Least 50% in Mean Weekly Pain Score
timeFrame: Weeks 1-14 Endpoint BOCF (modified baseline observation carried forward)
measure: Responders - Decreases of at Least 30% in Mean Weekly Pain Score
timeFrame: Weeks 1-14 endpoint BOCF
measure: Duration Adjusted Average Change From Baseline in NRS Pain Scores
timeFrame: Weekly: Week 1 - Week 14
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Sacramento
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: Stanford
country: United States
facility: Pfizer Investigational Site
state: California
city: West Hollywood
country: United States
facility: Pfizer Investigational Site
state: California
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pensacola
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Safety Harbor
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Vero Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Honolulu
country: United States
facility: Pfizer Investigational Site
state: Hawaii
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Saint Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Longview
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Ponce
country: Puerto Rico
facility: Pfizer Investigational Site
city: San Juan
country: Puerto Rico
facility: Pfizer Investigational Site
city: San Juan
country: Puerto Rico
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: