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:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00264875
First received: December 12, 2005
Last updated: March 20, 2009
Last verified: March 2009
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To evaluate the safety and efficacy of pregabalin in reducing neuropathic pain associated with HIV neuropathy
Condition | Intervention | Phase |
---|---|---|
Peripheral Neuropathy HIV Infections |
Drug: pregabalin |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | An Open-Label, Extension Safety And Efficacy Trial Of Pregabalin In Subjects With Neuropathic Pain Associated With Human Immunodeficiency Virus (HIV) Neuropathy |
Resource links provided by NLM:
Genetics Home Reference related topics:
Charcot-Marie-Tooth disease
complement factor I deficiency
hereditary neuropathy with liability to pressure palsies
Drug Information available for:
Pregabalin
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Mean Visual Analogue Scale (VAS) Pain Scores [ Time Frame: Baseline, Week 4, Week 8, Week 12, and Endpoint ] [ Designated as safety issue: No ]
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 |
---|---|
Experimental: 1 |
Drug: pregabalin
75mg BID, titrated up to 300mg according to individual response and tolerability
|
![](https://webarchive.library.unt.edu/web/20130312000204im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00264875
Show 37 Study Locations
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Sponsors and Collaborators
Pfizer
Investigators
Study Director: | Pfizer CT.gov Call Center | Pfizer |
![](https://webarchive.library.unt.edu/web/20130312000204im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Additional Information:
No publications provided
Responsible Party: | Director, Clinical Trials Disclosure Group, Pfizer, Inc. |
ClinicalTrials.gov Identifier: | NCT00264875 History of Changes |
Other Study ID Numbers: | A0081095 |
Study First Received: | December 12, 2005 |
Results First Received: | February 20, 2009 |
Last Updated: | March 20, 2009 |
Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Peripheral Nervous System Diseases Demyelinating Diseases Polyneuropathies Nerve Compression Syndromes Neurologic Manifestations Neurotoxicity Syndromes Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Slow Virus Diseases Immune System Diseases Neuromuscular Diseases Nervous System Diseases Signs and Symptoms Poisoning Substance-Related Disorders Pregabalin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 10, 2013