Overview

Analgesic Efficacy and Safety Study of T-62 in Subjects With Postherpetic Neuralgia

Status:
Terminated

Trial end date:
2009-06-01

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is to evaluate the safety and efficacy of T-62 in subjects with postherpetic neuralgia.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Pfizer

Treatments:

Analgesics

Criteria

Inclusion criteria (additional criteria apply):

1. 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.

2. Subject is in general good health.

3. 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):

1. Subject has a current acute disease or unstable chronic disease other than post
herpetic neuralgia.

2. 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.

3. Subject is being treated for a medical condition that affects cardiac conduction.

4. Subject's plasma alanine aminotransferase (ALT) aspartate aminotransferase (AST),
total bilirubin, and alkaline phosphatase (AP) values are not within the normal
reference ranges.

5. Subject has a history of asthma requiring management for reactive airway disease in
the last year.

6. 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.

7. Subject currently requires anticonvulsant medications to control seizures.