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

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: NCT00376454
Recruitment Status : Completed
First Posted : September 14, 2006
Last Update Posted : February 12, 2013
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Drug: GW493838 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2002
Actual Primary Completion Date : June 2003
Actual Study Completion Date : June 2003

Primary Outcome Measures :
  1. Pain intensity

Secondary Outcome Measures :
  1. Safety Pain relief Global Impression of Change Pain quality Evoked pain intensity Area of allodynia Onset of effect Responder rate Rescue medication pharmacokinetics

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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): NCT00376454

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Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline Identifier: NCT00376454     History of Changes
Other Study ID Numbers: A1A20004
First Posted: September 14, 2006    Key Record Dates
Last Update Posted: February 12, 2013
Last Verified: February 2013

Keywords provided by GlaxoSmithKline:
neuropathic pain

Additional relevant MeSH terms:
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms