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

NCT00809679 | Terminated Phase 2 DMC

• 1 other identifier: K862-08-2002
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 13

Brief Summary

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

Conditions

Postherpetic Neuralgia

Keywords

Postherpetic neuralgia; Varicella Zoster; Shingles; Neuropathic pain; Analgesia; Pain

Outcome Measures

Primary Outcomes (1)

• Change in pain scores from baseline to following treatment.

  weekly

Secondary Outcomes (2)

• General safety monitoring (adverse reactions, vital signs, electrocardiograms, clinical laboratories)

  weekly

• Pharmacokinetics

  weekly

Study Arms (3)

T-62 100 mg bid

EXPERIMENTAL

Drug: T-62 Dose 1

T-62 200 mg bid

EXPERIMENTAL

Drug: T-62 Dose 2

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

T-62 Dose 1 DRUG

Capsule dosage form 100 mg bid

T-62 100 mg bid

T-62 Dose 2 DRUG

Capsule dosage form 200 mg bid

T-62 200 mg bid

Placebo OTHER

Capsule dosage form placebo bid

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (13)

Unknown Facility

Tucson, Arizona, United States

Location

Unknown Facility

Westlake Village, California, United States

Location

Unknown Facility

Bradenton, Florida, United States

Location

Unknown Facility

Naples, Florida, United States

Location

Unknown Facility

New Port Richey, Florida, United States

Location

Unknown Facility

Sunrise, Florida, United States

Location

Unknown Facility

Tampa, Florida, United States

Location

Unknown Facility

Lexington, Kentucky, United States

Location

Unknown Facility

Albuquerque, New Mexico, United States

Location

Unknown Facility

Winston-Salem, North Carolina, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Spokane, Washington, United States

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic; Herpes Zoster; Neuralgia; Agnosia; Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Perceptual Disorders; Neurobehavioral Manifestations

Study Officials

• Robert L. Rolleri, Pharm. D.

  King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2008
• First Posted: December 17, 2008
• Study Start: December 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: June 8, 2012

Record last verified: 2012-06

Locations

US (13)