Status:
TERMINATED
Analgesic Efficacy and Safety Study of T-62 in Subjects With Postherpetic Neuralgia
Lead Sponsor:
Pfizer
Conditions:
Postherpetic Neuralgia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of T-62 in subjects with postherpetic neuralgia.
Detailed Description
Study K862-08-2002 is a multicenter, randomized, double-blind, placebo-controlled study assessing the analgesic efficacy and safety of T-62 in subjects with postherpetic neuralgia (PHN) and its associ...
Eligibility Criteria
Inclusion
- Inclusion criteria (additional criteria apply):
- Diagnosis of PHN made by primary treating physician and is experiencing pain for at least 3 months after the healing of a herpes zoster rash.
- Subject is in general good health.
- Females must be non-pregnant, non-lactating, and practicing an acceptable method of birth control or be surgically sterile or post-menopausal. Double barrier methods and abstinence are the only acceptable birth control methods for this study.
- Exclusion Criteria (additional criteria apply):
- Subject has a current acute disease or unstable chronic disease other than post herpetic neuralgia.
- Subject has a clinically important history of a medical disorder (particularly cardiovascular, neurological \[e.g., diabetic neuropathy\], respiratory, or hepato-biliary systems \[e.g., Gilbert Syndrome\]) that would confound and/or interfere with the safety and efficacy evaluations defined in the protocol.
- Subject is being treated for a medical condition that affects cardiac conduction.
- Subject's plasma alanine aminotransferase (ALT) aspartate aminotransferase (AST), total bilirubin, and alkaline phosphatase (AP) values are not within the normal reference ranges.
- Subject has a history of asthma requiring management for reactive airway disease in the last year.
- Subject uses and is unwilling/unable to discontinue use of (A) Lyrica® (pregabalin), Cymbalta® (duloxetine), Neurontin® (gabapentin), topical lidocaine, topical capsaicin, or other medication specifically indicated (i.e., labeled) for the treatment of neuropathic pain, or (B) anticonvulsant medications to control post herpetic neuralgia.
- Subject currently requires anticonvulsant medications to control seizures.
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00809679
Start Date
December 1 2008
End Date
June 1 2009
Last Update
June 8 2012
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
Tucson, Arizona, United States
2
Westlake Village, California, United States
3
Bradenton, Florida, United States
4
Naples, Florida, United States