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Recruitment Status : Withdrawn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
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Brief Summary:
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 or disease Intervention/treatment Phase
Postherpetic Neuralgia Drug: T-62 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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 the National Library of Medicine

MedlinePlus related topics: Shingles
U.S. FDA Resources

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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
Pfizer Identifier: NCT00506610     History of Changes
Other Study ID Numbers: K862-06-2001
First Posted: July 25, 2007    Key Record Dates
Last Update Posted: June 7, 2012
Last Verified: June 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