Clinical trial NCT00809679: Analgesic Efficacy and Safety Study of T-62 in Subjects With Postherpetic Neuralgia
Official title: A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled, Pilot Analgesic Efficacy and Safety Study of T-62 in Subjects With Postherpetic Neuralgia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Postherpetic Neuralgia
Keywords: Postherpetic neuralgia
Varicella Zoster
Shingles
Neuropathic pain
Analgesia
Pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-12-17
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 associated pain. Up to 20 centers in the United States will participate in the trial. Two doses of T-62 and placebo will be evaluated in parallel design. Approximately 130 subjects will be enrolled to complete approximately 100 subjects. Each subject will complete a 7-day Screening Period , a 28-day Treatment Period, and a 14-day Post-Treatment Period. Each subject will complete 8 clinic visits over the course of the study during which procedures and assessments of safety, efficacy, and protocol compliance will be performed.

Eligibility 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.

Primary outcomes:
measure: Change in pain scores from baseline to following treatment.
timeFrame: weekly
Secondary outcomes:
measure: General safety monitoring (adverse reactions, vital signs, electrocardiograms, clinical laboratories)
timeFrame: weekly
measure: Pharmacokinetics
timeFrame: weekly
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Westlake Village
country: United States
state: California
city: Bradenton
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Sunrise
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Lexington
country: United States
state: Kentucky
city: Albuquerque
country: United States
state: New Mexico
city: Winston-Salem
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: San Antonio
country: United States
state: Texas
city: Spokane
country: United States
state: Washington
Study officials:
affiliation: King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
name: Robert L. Rolleri, Pharm. D.
role: STUDY_DIRECTOR
References: