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