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

This study has been terminated.
(Some patients experienced asymptomatic, transient elevations in liver transaminases)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00809679
First received: December 15, 2008
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Postherpetic Neuralgia
Drug: T-62 Dose 1
Drug: T-62 Dose 2
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled, Pilot Analgesic Efficacy and Safety Study of T-62 in Subjects With Postherpetic Neuralgia

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change in pain scores from baseline to following treatment. [ Time Frame: weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • General safety monitoring (adverse reactions, vital signs, electrocardiograms, clinical laboratories) [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: weekly ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: December 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Placebo Other: Placebo
Capsule dosage form placebo bid

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809679

Locations
United States, Arizona
Tucson, Arizona, United States
United States, California
Westlake Village, California, United States
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
United States, Kentucky
Lexington, Kentucky, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, North Carolina
Winston-Salem, North Carolina, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Texas
San Antonio, Texas, United States
United States, Washington
Spokane, Washington, United States
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Robert L. Rolleri, Pharm. D. King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00809679     History of Changes
Other Study ID Numbers: K862-08-2002
Study First Received: December 15, 2008
Last Updated: June 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Postherpetic neuralgia
Varicella Zoster
Shingles
Neuropathic pain
Analgesia
Pain

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014