|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00617461 |
Purpose
The purpose of this study is evaluate the difference between two doses of XP13512/GSK1838262 on pain associated with post-herpetic neuralgia
| Condition | Intervention | Phase |
|---|---|---|
|
Pain Associated With Post-Herpetic Neuralgia |
Drug: XP13512/GSK1838262 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Efficacy Study |
| Official Title: | Study PXN110527: The Investigation of the Efficacy and Pharmacokinetics of XP13512 in Subjects With Neuropathic Pain Associated With Post-herpetic Neuralgia (PHN) Who Have Had an Inadequate Response to Gabapentin Treatment. |
| Estimated Enrollment: | 98 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | July 2009 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
XP13512: Experimental
1200mg and 3600mg
|
Drug: XP13512/GSK1838262
1200mg and 3600mg
|
Eligibility| 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:
Subjects with the above definition of PHN must satisfy the following criteria to be eligible for the study:
Subjects may previously have been on >1800 mg/day of gabapentin since diagnosis of PHN.
Exclusion Criteria:
Subjects meeting any of the following criteria must not be enrolled in the study:
Examples of such medical conditions include:
Contacts and Locations
Show 55 Study Locations| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 110527 |
| Study First Received: | February 6, 2008 |
| Last Updated: | July 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00617461 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Food and Drug Administration |
|
Neuropathic pain Post-herpetic neuralgia(PHN) |
|
Neuralgia, Postherpetic Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Gabapentin Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Calcium Channel Blockers Excitatory Amino Acid Agents Pain Membrane Transport Modulators Signs and Symptoms Neuromuscular Diseases Sensory System Agents |
Therapeutic Uses Analgesics Excitatory Amino Acid Antagonists Tranquilizing Agents Neuralgia Nervous System Diseases Central Nervous System Depressants Cardiovascular Agents Antimanic Agents Pharmacologic Actions Peripheral Nervous System Diseases Neurologic Manifestations Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents |