Not Signed In -
Hereditary neuropathy with liability to pressure palsies |
compression neuropathy; entrapment neuropathy; familial pressure sensitive neuropathy; HNPP; inherited tendency to pressure palsies; tomaculous neuropathy |
Clinical Trial: Open Label Safety And Efficacy Study Of Pregabalin In Subjects With Nerve Pain Asociated With HIV Neuropathy
This study is not yet open for patient recruitment.
Verified by Pfizer December 2005
|
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: Peripheral Nerve Disorders
Genetics Home Reference related topics: Peripheral Nerve Disorders
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, 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 Outcomes: Safety and tolerability of pregabalin based on adverse events, physical and neurological examination, and laboratory tests
Secondary Outcomes: Efficacy assessed by VAS pain scores
Expected Total Enrollment: 300
Secondary Outcomes: Efficacy assessed by VAS pain scores
Expected Total Enrollment: 300
Study start: January 2006
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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;
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00264875
Study chairs or principal investigators
Pfizer CT.gov Call Center, Study Director, Pfizer
More Information
Study ID Numbers: A0081095
Last Updated: December 12, 2005
Record first received: December 12, 2005
ClinicalTrials.gov Identifier: NCT00264875
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10
Last Updated: December 12, 2005
Record first received: December 12, 2005
ClinicalTrials.gov Identifier: NCT00264875
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10
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