This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

A Study to Determine if an Investigational Pain Medicine Provides Relief of Chronic Pain After a Shingles Outbreak

This study has been withdrawn prior to enrollment.
Information provided by:
Pfizer Identifier:
First received: July 24, 2007
Last updated: June 6, 2012
Last verified: June 2012
The purpose of this study is to determine whether T-62 is effective in providing relief of pain that can occur after an individual experiences a shingles outbreak, which is an infection in adults caused by the same virus that causes chicken pox.

Condition Intervention Phase
Postherpetic Neuralgia Drug: T-62 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Flexible Escalating -Dose, Pilot Analgesic Efficacy Study of T-62 in Subjects With Postherpetic Neuralgia

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Pain Intensity Difference (PID) scores (derived from data obtained using the 11 point Likert pain rating scale) [ Time Frame: During each Treatment Phase Visit ]
  • Various pain related assessment [ Time Frame: During each Treatment Phase Visit ]
  • Clinical Global Impression of Change (CGIC) and Subject Global Impression of Change (SGIC ) scores [ Time Frame: At each Treatment Phase Visit ]

Secondary Outcome Measures:
  • Incidence, intensity, relationship, and seriousness of treatment-emergent AEs by dose and by treatment group.
  • Treatment-emergent changes in safety assessments
  • Evaluation of T-62 plasma concentrations [ Time Frame: At various timepoints during the study ]

Enrollment: 0

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Has a clinical diagnosis of Postherpetic Neuralgia (PHN)
  • Experiencing pain for at least 3 months after the healing of shingles rash
  • Has at least a weekly average pain intensity of equal to or greater than 4 out of 10
  • Females must not be pregnant or breastfeeding and practicing an acceptable method of birth control, or be surgically sterile or post-menopausal
  • Will not consume grapefruit or grapefruit juice during the study

Exclusion Criteria:

  • Has a current acute or unstable chronic disease other than Postherpetic Neuralgia (PHN)
  • Has clinically important medical disorder
  • Uses certain types of medications for heart conditions
  • Unwilling/unable to discontinue use of medications for treatment of neuropathic pain
  • Has a history of hypersensitivity to any medication or soy product
  • Has liver or kidney disease
  • Has asthma that required treatment within the last year
  • Has HIV or hepatitis (other than hepatitis A)
  • Has a history of alcohol abuse within the past 2 years
  • Has a history of (within last 2 years) or currently abuses prescription or illegal drugs
  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 identifier: NCT00506610

United States, Florida
Bradenton Research Center
Bradenton, Florida, United States, 34205
Anchor Research Center
Naples, Florida, United States, 34102
Suncoast Clinical Research
New Port Richey, Florida, United States, 34652
United States, North Carolina
The Center for Clinical Research
Winston Salem, North Carolina, United States, 27103
United States, North Dakota
Plains Medical Clinic
Fargo, North Dakota, United States, 58104
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
United States, South Carolina
Crescent Moon Research
Murrells Inlet, South Carolina, United States, 29576
United States, Washington
Odyssey Research
Spokane, Washington, United States, 99204
Sponsors and Collaborators
  More Information Identifier: NCT00506610     History of Changes
Other Study ID Numbers: K862-06-2001
Study First Received: July 24, 2007
Last Updated: June 6, 2012

Keywords provided by Pfizer:
Postherpetic Neuralgia
Neuralgia, Postherpetic
Herpes Zoster
Neuropathic Pain

Additional relevant MeSH terms:
Neuralgia, Postherpetic
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms processed this record on September 21, 2017