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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00643760 |
The purpose of this study is to determine whether XP13512/GSK1838262 is effective in the treatment of neuropathic pain associated with diabetic peripheral neuropathy(DPN)
Condition | Intervention | Phase |
---|---|---|
Neuropathic Pain From Peripheral Diabetic Neuropathy |
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 PXN110448: A Dose-Response Study of XP13512, Compared With Concurrent Placebo Control and LYRICA(Pregabalin), in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (DPN) |
Enrollment: | 421 |
Study Start Date: | March 2008 |
Study Completion Date: | February 2009 |
Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Pregabalin positive control
Pregabalin
|
Drug: XP13512/GSK1838262
XP13512
|
Placebo: Placebo Comparator
Placebo
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Drug: XP13512/GSK1838262
XP13512
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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:
and
Note: Subjects who achieve stable glycemic control and meet HbA1c criteria through diet control are eligible.
and
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: | 110448 |
Study First Received: | February 19, 2008 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00643760 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Food and Drug Administration |
Peripheral Diabetic Neuropathy (PDN) Neuropathic Pain |
Neuromuscular Diseases Diabetic Neuropathies Peripheral Nervous System Diseases Diabetes Mellitus Pregabalin |
Endocrine System Diseases Pain Endocrinopathy Diabetes Complications |
Neuromuscular Diseases Diabetic Neuropathies Peripheral Nervous System Diseases Nervous System Diseases |
Diabetes Mellitus Endocrine System Diseases Diabetes Complications |