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

Last updated on December 6, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85023 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Peripheral Neuropathy, HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00264875
Pfizer
Completed
Open Label Safety And Efficacy Study Of Pregabalin In Subjects With Nerve Pain Asociated With Human Immunodeficiency Virus (HIV) Neuropathy

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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
Intervention Model: Single Group Assignment
Masking: None (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT00264875
A0081095
No
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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