Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be 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.
