Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery
NCT ID: NCT00366444
Last Updated: 2011-04-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
201 participants
INTERVENTIONAL
2006-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
diclofenac potassium (XP21L)
25 mg every 6 hours
2
Placebo
Placebo every 6 hours
Interventions
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diclofenac potassium (XP21L)
25 mg every 6 hours
Placebo
Placebo every 6 hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have undergone bunionectomy surgery
* Have achieved adequate post-surgical pain
Exclusion Criteria
* Participated in a study of another investigational drug or device within 30 days prior to randomization
18 Years
65 Years
ALL
No
Sponsors
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Xanodyne Pharmaceuticals
INDUSTRY
Responsible Party
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Xanodyne Pharmaceuticals, Inc.
Locations
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Investigative Site
Anaheim, California, United States
Investigative Site
Orange, California, United States
Investigative Site
Owings Mills, Maryland, United States
Investigative Site
Pasadena, Maryland, United States
Investigative Site
Altoona, Pennsylvania, United States
Investigative Site
Salt Lake City, Utah, United States
Countries
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References
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Riff DS, Duckor S, Gottlieb I, Diamond E, Soulier S, Raymond G, Boesing SE. Diclofenac potassium liquid-filled soft gelatin capsules in the management of patients with postbunionectomy pain: a Phase III, multicenter, randomized, double-blind, placebo-controlled study conducted over 5 days. Clin Ther. 2009 Oct;31(10):2072-85. doi: 10.1016/j.clinthera.2009.09.011.
Daniels SE, Riff D, Diamond E, Clark F, Boesing SE. An assessment of the efficacy and safety of diclofenac potassium liquid-filled capsules in patients with various levels of baseline pain intensity. Curr Med Res Opin. 2012 Jun;28(6):953-61. doi: 10.1185/03007995.2012.694363. Epub 2012 Jun 11.
Related Links
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Related Info
Related Info
Other Identifiers
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XP21L-301
Identifier Type: -
Identifier Source: org_study_id
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