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

A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled, Pilot Analgesic Efficacy and Safety Study of T-62 in Subjects With Postherpetic Neuralgia

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

Study Overview

• Status: Terminated
• Conditions: Postherpetic Neuralgia
• Intervention / Treatment: Drug: T-62 Dose 1; Drug: T-62 Dose 2; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States
  • California
    • Westlake Village, California, United States
  • Florida
    • Bradenton, Florida, United States
    • Naples, Florida, United States
    • New Port Richey, Florida, United States
    • Sunrise, Florida, United States
    • Tampa, Florida, United States
  • Kentucky
    • Lexington, Kentucky, United States
  • New Mexico
    • Albuquerque, New Mexico, United States
  • North Carolina
    • Winston-Salem, North Carolina, United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
  • Texas
    • San Antonio, Texas, United States
  • Washington
    • Spokane, Washington, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Capsule dosage form placebo bid
Experimental: T-62 100 mg bid	Drug: T-62 Dose 1; Capsule dosage form 100 mg bid
Experimental: T-62 200 mg bid	Drug: T-62 Dose 2; Capsule dosage form 200 mg bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in pain scores from baseline to following treatment.	weekly

Secondary Outcome Measures

Outcome Measure	Time Frame
General safety monitoring (adverse reactions, vital signs, electrocardiograms, clinical laboratories)	weekly
Pharmacokinetics	weekly

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Robert L. Rolleri, Pharm. D., King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: December 15, 2008
• First Submitted That Met QC Criteria: December 16, 2008
• First Posted (Estimate): December 17, 2008

Study Record Updates

• Last Update Posted (Estimate): June 8, 2012
• Last Update Submitted That Met QC Criteria: June 6, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Pain; Analgesia; Neuropathic pain; Shingles; Postherpetic neuralgia; Varicella Zoster
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Neuralgia, Postherpetic
• Other Study ID Numbers: K862-08-2002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No