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

NCT ID: NCT00809679

Last Updated: 2012-06-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-06-30

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.

Conditions

Postherpetic Neuralgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

T-62 100 mg bid

Group Type: EXPERIMENTAL

T-62 Dose 1

Intervention Type: DRUG

Capsule dosage form 100 mg bid

T-62 200 mg bid

Group Type: EXPERIMENTAL

T-62 Dose 2

Intervention Type: DRUG

Capsule dosage form 200 mg bid

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Capsule dosage form placebo bid

Interventions

T-62 Dose 1

Capsule dosage form 100 mg bid

Intervention Type: DRUG

T-62 Dose 2

Capsule dosage form 200 mg bid

Intervention Type: DRUG

Placebo

Capsule dosage form placebo bid

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert L. Rolleri, Pharm. D.

Role: STUDY_DIRECTOR

King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

Locations

Tucson, Arizona, United States

Westlake Village, California, United States

Bradenton, Florida, United States

Naples, Florida, United States

New Port Richey, Florida, United States

Sunrise, Florida, United States

Tampa, Florida, United States

Lexington, Kentucky, United States

Albuquerque, New Mexico, United States

Winston-Salem, North Carolina, United States

Oklahoma City, Oklahoma, United States

San Antonio, Texas, United States

Spokane, Washington, United States

Countries

United States

Other Identifiers

K862-08-2002

Identifier Type: -

Identifier Source: org_study_id