Last updated: 11/04/2018 04:18:14
The study of GW493838, an adenosine A1 agonist, in peripheral neuropathic pain
GSK study ID
A1A20004
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
113
Primary completion date:
2003-30-06
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
neuropathic pain
Product
GW493838
Collaborators
None
Study date(s)
November 2002 to June 2003
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 80 Years
Accepts healthy volunteers
No
- Inclusion criteria (subjects must meet all of the following criteria in order to be eligible for this study):
- Females of non-child-bearing potential
Inclusion and exclusion criteria
Inclusion 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.
Trial location(s)
Location
GSK Clinical Trials Call Center
Evansville, IN, United States, 47712
Status
Study Complete
Location
GSK Clinical Trials Call Center
Palm Beach, FL, United States, 33409
Status
Study Complete
Location
GSK Clinical Trials Call Center
Altoona, PA, United States, 16601
Status
Study Complete
Location
GSK Clinical Trials Call Center
Louisville, KY, United States, 40205
Status
Study Complete
Location
GSK Clinical Trials Call Center
Pembroke Pines, FL, United States, 33024
Status
Study Complete
Location
GSK Clinical Trials Call Center
Richardson, TX, United States, 75080
Status
Study Complete
Showing 1 - 6 of 32 Results
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Study complete
Actual primary completion date
2003-30-06
Actual study completion date
2003-30-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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