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

Completed · Phase 2

Conditions studied: Neuropathic Pain

In brief

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.

Key facts

Study ID

NCT00376454

Run by

GlaxoSmithKline

People needed

113

Starts

2002-11-01

Expected to finish

2003-06-01

Last updated by the study team

2013-02-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• GSK Clinical Trials Call Center — Huntsville, Alabama, United States
• GSK Clinical Trials Call Center — Hot Springs, Arizona, United States
• GSK Clinical Trials Call Center — Little Rock, Arkansas, United States
• GSK Clinical Trials Call Center — La Jolla, California, United States
• GSK Clinical Trials Call Center — Oceanside, California, United States
• GSK Clinical Trials Call Center — Boulder, Colorado, United States
• GSK Clinical Trials Call Center — Fort Lauderdale, Florida, United States
• GSK Clinical Trials Call Center — Fort Myers, Florida, United States
• GSK Clinical Trials Call Center — Palm Beach, Florida, United States
• GSK Clinical Trials Call Center — Palm Beach Gardens, Florida, United States
• GSK Clinical Trials Call Center — Pembroke Pines, Florida, United States
• GSK Clinical Trials Call Center — South Daytona, Florida, United States
• GSK Clinical Trials Call Center — St. Petersburg, Florida, United States
• GSK Clinical Trials Call Center — West Palm Beach, Florida, United States
• GSK Clinical Trials Call Center — Evansville, Indiana, United States
• GSK Clinical Trials Call Center — Lexington, Kentucky, United States
• GSK Clinical Trials Call Center — Louisville, Kentucky, United States
• GSK Clinical Trials Call Center — Louisville, Kentucky, United States
• GSK Clinical Trials Call Center — Covington, Louisiana, United States
• GSK Clinical Trials Call Center — Boston, Massachusetts, United States
• GSK Clinical Trials Call Center — Henderson, Nevada, United States
• GSK Clinical Trials Call Center — Lebanon, New Hampshire, United States
• GSK Clinical Trials Call Center — Ridgewood, New Jersey, United States
• GSK Clinical Trials Call Center — Albany, New York, United States
• GSK Clinical Trials Call Center — Asheville, North Carolina, United States

Full record on ClinicalTrials.gov

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