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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This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00506610
First received: July 24, 2007
Last updated: June 6, 2012
Last verified: June 2012

July 24, 2007
June 6, 2012
Not Provided
Not Provided
  • 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 ClinicalTrials.gov 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
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Postherpetic Neuralgia
Drug: T-62
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00506610
K862-06-2001
No
Not Provided
Pfizer
Not Provided
Not Provided
Pfizer
June 2012

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