Open Label Safety And Efficacy Study Of Pregabalin In Subjects With Nerve Pain Asociated With HIV Neuropathy - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00264875

Purpose

To evaluate the safety and efficacy of pregabalin in reducing neuropathic pain associated with HIV neuropathy

Condition	Intervention	Phase
Peripheral Neuropathy HIV	Drug: pregabalin	Phase III

MedlinePlus related topics: AIDS Peripheral Nerve Disorders

Drug Information available for: Pregabalin

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Extension Safety And Efficacy Trial Of Pregabalin In Subjects With Neuropathic Pain Associated With HIV Neuropathy

Further study details as provided by Pfizer:

Primary Outcome Measures:

Efficacy assessed by visual analog scale (VAS) pain scores. [ Time Frame: Day 1, week 4, week 8, and week 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Adverse event information [ Time Frame: Thoughout the study ] [ Designated as safety issue: Yes ]
Physical exam/ neurological exam [ Time Frame: screening and termination ] [ Designated as safety issue: Yes ]
Lab tests [ Time Frame: Day 1, week 12 and week 13 ] [ Designated as safety issue: Yes ]

Enrollment:	220
Study Start Date:	February 2006
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: pregabalin 75mg BID, titrated up to 300mg according to individual response and tolerability

Eligibility

Criteria

Inclusion Criteria:

Participation in the preceding A0081066 double-blind trial met the entry criteria for that trial and completed A0081066 study through visit 7

Exclusion Criteria:

Experienced serious adverse event during the A0081066 trial that was considered related or possibly related to study medication by the investigator or sponsor
non-compliant during A0081066 trial
clinically significant or unstable medical condition both HIV-related and non-HIV related including but not limited to, cardiac, pulmonary or hepatorenal disease that, in the opinion of the investigator, would compromise participation in the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264875

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A0081095
Study First Received:	December 12, 2005
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00264875
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neuromuscular Diseases
HIV Infections
Peripheral Nervous System Diseases

Acquired Immunodeficiency Syndrome
Pregabalin
Pain

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Peripheral Nervous System Agents

Analgesics
Central Nervous System Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009