Study of Pregabalin Versus Placebo in the Treatment of Nerve Pain Associated With HIV Neuropathy - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00232141

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 III

MedlinePlus related topics: AIDS Peripheral Nerve Disorders

Drug Information available for: Pregabalin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Pfizer:

Primary Outcome Measures:

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. [ Time Frame: every visit from visit 1 to visit 6 (12th week) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Standard Safety Assessment - record from the time the subject has taken at least one dose of trial treatment through last subject visit. [ Time Frame: throughout the trial ] [ Designated as safety issue: Yes ]
MOS Sleep Scale; Hospital Anxiety and Depression Scale; Gracely Pain Scale; Neuropathic Pain Symptom Inventory Scale; Quantitative Assessment of Neuropathic Pain Scale [ Time Frame: Day 1(V2) and end of week 14 (V7) ] [ Designated as safety issue: Yes ]
Laboratory Assessment [ Time Frame: Screening, end of week 12 (V6) and end of week 13 (V7) ] [ Designated as safety issue: Yes ]
Brief Pain Inventory [ Time Frame: Day1, end of Weeks 1, 2, 6, 10, 14 ] [ Designated as safety issue: Yes ]
Proportion of subjects experiencing 30 and 50% reduction in pain at endpoint (responder rates); Weekly mean pain scores and sleep diary ratings (from the daily pain and sleep diary) [ Time Frame: end of study ] [ Designated as safety issue: Yes ]
Patient Global Impression of Change [ Time Frame: end of week 14 (V7) ] [ Designated as safety issue: Yes ]

Enrollment:	303
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
1: Experimental	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)
2: Placebo Comparator	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

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

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A0081066
Study First Received:	September 30, 2005
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00232141
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Neuromuscular Diseases
HIV Infections
Peripheral Nervous System Diseases
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Pregabalin
Pain
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Nervous System Diseases
Physiological Effects of Drugs
Infection
Pharmacologic Actions

Sensory System Agents
Therapeutic Uses
Lentivirus Infections
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009