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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This study has been withdrawn prior to enrollment.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
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00506610

Locations
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00506610     History of Changes
Other Study ID Numbers: K862-06-2001
Study First Received: July 24, 2007
Last Updated: June 6, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
 Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013