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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014