The Study of GW493838, an Adenosine A1 Agonist, in Peripheral Neuropathic Pain
NCT ID: NCT00376454
Last Updated: 2013-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
113 participants
INTERVENTIONAL
2002-11-30
2003-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Assess the Efficacy, Safety, and Tolerability of ADL5747 in Participants With Postherpetic Neuralgia
NCT01058642
Study in Neuropathic Pain Patients With Peripheral Nerve Injury
NCT00969059
Safety and Efficacy of AGN 203818 in Patients With Painful Diabetic Peripheral Neuropathy
NCT00381719
Dose-Tolerability Titration Study to Evaluate The Efficacy And Safety Of Perampanel (E2007) In Patients With Post-Herpetic Neuralgia (PHN)
NCT00592774
A Study Into Pain Relief Given by ASP8477 for Peripheral Neuropathic Pain (Either Post-herpetic Neuralgia or Painful Diabetic Peripheral Neuropathy) and Its Safety
NCT02065349
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GW493838
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
GSK Clinical Trials, MD
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
GSK Clinical Trials Call Center
Winston-Salem, North Carolina, United States
GSK Clinical Trials Call Center
Tulsa, Oklahoma, United States
GSK Clinical Trials Call Center
Altoona, Pennsylvania, United States
GSK Clinical Trials Call Center
Duncansville, Pennsylvania, United States
GSK Clinical Trials Call Center
Richardson, Texas, United States
GSK Clinical Trials Call Center
Tacoma, Washington, United States
GSK Clinical Trials Call Center
Madison, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
A1A20004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.