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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00506610
Recruitment Status : Withdrawn
First Posted : July 25, 2007
Last Update Posted : June 7, 2012
Information provided by:

July 24, 2007
July 25, 2007
June 7, 2012
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  • 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 ]
Same as current
Complete list of historical versions of study NCT00506610 on Archive Site
  • 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 ]
Same as current
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A Study to Determine if an Investigational Pain Medicine Provides Relief of Chronic Pain After a Shingles Outbreak
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Flexible Escalating -Dose, Pilot Analgesic Efficacy Study of T-62 in Subjects With Postherpetic Neuralgia
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.
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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Postherpetic Neuralgia
Drug: T-62
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP