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This study has been withdrawn prior to recruitment.

First Received: July 24, 2007 Last Updated: November 9, 2007 History of Changes

Sponsored by:	King Pharmaceuticals Research and Development
Information provided by:	King Pharmaceuticals Research and Development
ClinicalTrials.gov Identifier:	NCT00506610

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Shingles

U.S. FDA Resources

Further study details as provided by King Pharmaceuticals Research and Development:

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 ]

Estimated Enrollment:

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
Suncoast Clinical Research
New Port Richey, Florida, United States, 34652
Anchor Research Center
Naples, Florida, United States, 34102
Bradenton Research Center
Bradenton, Florida, United States, 34205
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

King Pharmaceuticals Research and Development

More Information

No publications provided

Study ID Numbers:	K862-06-2001
Study First Received:	July 24, 2007
Last Updated:	November 9, 2007
ClinicalTrials.gov Identifier:	NCT00506610 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by King Pharmaceuticals Research and Development:

Pain
Postherpetic Neuralgia
Neuralgia, Postherpetic

Shingles
Herpes Zoster
Neuropathic Pain

Study placed in the following topic categories:

Neuralgia, Postherpetic
Herpes Zoster
Signs and Symptoms
Neuromuscular Diseases
Neuralgia

Peripheral Nervous System Diseases
Neurologic Manifestations
Pain
Analgesics

Additional relevant MeSH terms:

Neuralgia, Postherpetic
Signs and Symptoms
Neuromuscular Diseases
Neuralgia

Peripheral Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Pain

ClinicalTrials.gov processed this record on September 03, 2009