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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00376454
First received: September 13, 2006
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention Phase
Neuropathic Pain
 Drug: GW493838
 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 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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Pain intensity

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

Estimated Enrollment: 113
Study Start Date: November 2002
Study Completion Date: June 2003
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00376454

  Show 32 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00376454     History of Changes
Other Study ID Numbers: A1A20004
Study First Received: September 13, 2006
Last Updated: February 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
neuropathic pain

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

ClinicalTrials.gov processed this record on May 23, 2013