The Study of GW493838, an Adenosine A1 Agonist, in Peripheral Neuropathic Pain

February 11, 2013 updated by: GlaxoSmithKline

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Tolerability of a 14 Day Treatment Course of GW493838 50mg Compared to Placebo in Subjects With Peripheral Neuropathic Pain

The purpose of this study was to determine the analgesic effect of GW493838 in patients with post-herpetic neuralgia or peripheral nerve injury caused by trauma or surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

113

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
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • GSK Clinical Trials Call Center
    • Arizona
      • Hot Springs, Arizona, United States, 71913
        • GSK Clinical Trials Call Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • GSK Clinical Trials Call Center
    • California
      • La Jolla, California, United States, 92037
        • GSK Clinical Trials Call Center
      • Oceanside, California, United States, 92056
        • GSK Clinical Trials Call Center
    • Colorado
      • Boulder, Colorado, United States, 80304
        • GSK Clinical Trials Call Center
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • GSK Clinical Trials Call Center
      • Ft. Myers, Florida, United States, 33916
        • GSK Clinical Trials Call Center
      • Palm Beach, Florida, United States, 33409
        • GSK Clinical Trials Call Center
      • Palm Beach Gardens, Florida, United States, 33410
        • GSK Clinical Trials Call Center
      • Pembroke Pines, Florida, United States, 33024
        • GSK Clinical Trials Call Center
      • S. Daytona, Florida, United States, 32119
        • GSK Clinical Trials Call Center
      • St. Petersburg, Florida, United States, 33701
        • GSK Clinical Trials Call Center
      • West Palm Beach, Florida, United States, 33407
        • GSK Clinical Trials Call Center
    • Indiana
      • Evansville, Indiana, United States, 47712
        • GSK Clinical Trials Call Center
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • GSK Clinical Trials Call Center
      • Louisville, Kentucky, United States, 40202
        • GSK Clinical Trials Call Center
      • Louisville, Kentucky, United States, 40205
        • GSK Clinical Trials Call Center
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • GSK Clinical Trials Call Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • GSK Clinical Trials Call Center
    • Nevada
      • Henderson, Nevada, United States, 89052
        • GSK Clinical Trials Call Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • GSK Clinical Trials Call Center
    • New Jersey
      • Ridgewood, New Jersey, United States, 07450
        • GSK Clinical Trials Call Center
    • New York
      • Albany, New York, United States, 12205
        • GSK Clinical Trials Call Center
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • GSK Clinical Trials Call Center
      • Winston-Salem, North Carolina, United States, 27103
        • GSK Clinical Trials Call Center
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • GSK Clinical Trials Call Center
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16601
        • GSK Clinical Trials Call Center
      • Duncansville, Pennsylvania, United States, 16635
        • GSK Clinical Trials Call Center
    • Texas
      • Richardson, Texas, United States, 75080
        • GSK Clinical Trials Call Center
    • Washington
      • Tacoma, Washington, United States, 98405
        • GSK Clinical Trials Call Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • GSK Clinical Trials Call Center

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 to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria (subjects must meet all of the following criteria in order to be eligible for this study):

  • Females of non-child-bearing potential
  • diagnosis of peripheral neuropathic pain as a result of: postherpetic neuralgia (PHN) from shingles for at least 3 months duration OR focal neuropathic pain related to nerve injury caused by trauma or surgery
  • defined area of pain

Exclusion criteria

  • discontinue agents for the treatment of neuropathic pain
  • unable to refrain from alcohol and sedative use during the study
  • confounding chronic pain which could not be differentiated from the peripheral neuropathic pain under study
  • intractable pain of unknown origin or active infection in the area of nerve injury.
  • clinically significant medical history or abnormality found on physical examination, laboratory assessment or ECG at Screening or Baseline
  • severe asthma that has required oral corticosteroid use in the last 12 months or the subject had severe asthma that required, at anytime, hospitalization or mechanical ventilation support.
  • clinical evidence of major depression (by medical history) except those subjects controlled by SSRIs.
  • a known allergy or hypersensitivity to any of the investigational products (including rescue analgesia- acetaminophen), or pharmacological class of the investigational product (i.e. adenosine) and/or investigational product excipients.
  • a clinically significant abuse of substances, defined as: Patterns of substance intake consistent with disruption of normal function in society; Past or current impairment of organ function reasonably related to substance intake; Any indication of difficulty in abstaining from substances for the duration of the study.
  • had previously participated in a clinical study during the past 30 days in which the subject was exposed to an investigational or non-investigational drug or device
  • currently participating in another clinical study in which the subject was exposed to an investigational or non-investigational drug or device
  • prior blood reduction (450 mL or more) during the previous 30 days
  • at risk of non-compliance
  • a woman of childbearing potential or a woman who was lactating.

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
Pain intensity

Secondary Outcome Measures

Outcome Measure
Safety Pain relief Global Impression of Change Pain quality Evoked pain intensity Area of allodynia Onset of effect Responder rate Rescue medication pharmacokinetics

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

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 Major Dates

Study Start

November 1, 2002

Primary Completion (ACTUAL)

June 1, 2003

Study Completion (ACTUAL)

June 1, 2003

Study Registration Dates

First Submitted

September 13, 2006

First Submitted That Met QC Criteria

September 13, 2006

First Posted (ESTIMATE)

September 14, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

February 12, 2013

Last Update Submitted That Met QC Criteria

February 11, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1A20004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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