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

June 6, 2012 updated by: Pfizer

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.

Study Overview

Status

Withdrawn

Conditions

Postherpetic Neuralgia

Intervention / Treatment

Drug: T-62

Study Type

Interventional

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Florida
  - Bradenton, Florida, United States, 34205
    - Bradenton Research Center
  - Naples, Florida, United States, 34102
    - Anchor Research Center
  - New Port Richey, Florida, United States, 34652
    - Suncoast Clinical Research
- North Carolina
  - Winston Salem, North Carolina, United States, 27103
    - The Center for Clinical Research
- North Dakota
  - Fargo, North Dakota, United States, 58104
    - Plains Medical Clinic
- Pennsylvania
  - Duncansville, Pennsylvania, United States, 16635
    - Altoona Center for Clinical Research
- South Carolina
  - Murrells Inlet, South Carolina, United States, 29576
    - Crescent Moon Research
- Washington
  - Spokane, Washington, United States, 99204
    - Odyssey Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain Intensity Difference (PID) scores (derived from data obtained using the 11 point Likert pain rating scale) Time Frame: During each Treatment Phase Visit	During each Treatment Phase Visit
Various pain related assessment Time Frame: During each Treatment Phase Visit	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	At each Treatment Phase Visit

Secondary Outcome Measures

Outcome Measure	Time Frame
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	At various timepoints during the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

July 24, 2007

First Submitted That Met QC Criteria