Open Label Safety And Efficacy Study Of Pregabalin In Subjects With Nerve Pain Asociated With Human Immunodeficiency Virus (HIV) Neuropathy

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00264875
First received: December 12, 2005
Last updated: March 20, 2009
Last verified: March 2009

December 12, 2005
March 20, 2009
February 2006
February 2008   (final data collection date for primary outcome measure)
Mean Visual Analogue Scale (VAS) Pain Scores [ Time Frame: Baseline, Week 4, Week 8, Week 12, and Endpoint ] [ Designated as safety issue: No ]
Safety and tolerability of pregabalin based on adverse events, physical and neurological examination, and laboratory tests
Complete list of historical versions of study NCT00264875 on ClinicalTrials.gov Archive Site
Not Provided
Efficacy assessed by VAS pain scores
Not Provided
Not Provided
 
Open Label Safety And Efficacy Study Of Pregabalin In Subjects With Nerve Pain Asociated With Human Immunodeficiency Virus (HIV) Neuropathy
An Open-Label, Extension Safety And Efficacy Trial Of Pregabalin In Subjects With Neuropathic Pain Associated With Human Immunodeficiency Virus (HIV) Neuropathy

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

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Peripheral Neuropathy
  • HIV Infections
Drug: pregabalin
75mg BID, titrated up to 300mg according to individual response and tolerability
Experimental: 1
Intervention: Drug: pregabalin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
February 2008
February 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00264875
A0081095
No
Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2009

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