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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00619476 |
The purpose of this study is to determine whether XP13512/GSK1838262 is effective in the treatment of neuropathic pain associated with post-herpetic neuralgia (PHN)
Condition | Intervention | Phase |
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Neuropathic Pain Associated With Post-Herpetic Neuralgia |
Drug: XP13512/GSK1838262 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Study PXN110748: An Efficacy and Safety Study of XP13512 Compared With a Concurrent Placebo Control in Subjects With Neuropathic Pain Associated With Post-Herpetic Neuralgia (PHN) |
Estimated Enrollment: | 368 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Placebo: Placebo Comparator
placebo
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Drug: XP13512/GSK1838262
Investigational product
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Prior to randomization, subjects eligible for enrollment in the study must meet all of the following criteria:
Exclusion Criteria:
Subjects meeting any of the following criteria must not be enrolled in the study:
Examples of such medical conditions include:
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 110748 |
Study First Received: | February 7, 2008 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00619476 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Neuropathic pain Post-herpetic neuralgia |
Neuralgia, Postherpetic Signs and Symptoms Neuromuscular Diseases Neuralgia |
Peripheral Nervous System Diseases Neurologic Manifestations Pain |
Neuralgia, Postherpetic Signs and Symptoms Neuromuscular Diseases Neuralgia |
Peripheral Nervous System Diseases Nervous System Diseases Neurologic Manifestations Pain |