Status:
COMPLETED
The Study of GW493838, an Adenosine A1 Agonist, in Peripheral Neuropathic Pain
Lead Sponsor:
GlaxoSmithKline
Conditions:
Neuropathic Pain
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
End Date :
June 1 2003
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT00376454
Start Date
November 1 2002
End Date
June 1 2003
Last Update
February 12 2013
Active Locations (32)
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1
GSK Clinical Trials Call Center
Huntsville, Alabama, United States, 35801
2
GSK Clinical Trials Call Center
Hot Springs, Arizona, United States, 71913
3
GSK Clinical Trials Call Center
Little Rock, Arkansas, United States, 72205
4
GSK Clinical Trials Call Center
La Jolla, California, United States, 92037