Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery
NCT ID: NCT00375934
Last Updated: 2010-09-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
200 participants
INTERVENTIONAL
2006-09-30
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 capsule, every 6 hours
2
Placebo
Oral placebo capsule, every 6 hours
Interventions
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diclofenac potassium (XP21L)
25 mg capsule, every 6 hours
Placebo
Oral placebo capsule, 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
Austin, Texas, United States
Investigative Site
Houston, Texas, United States
Investigative Site
San Marcos, Texas, United States
Investigative Site
Salt Lake City, Utah, United States
Countries
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References
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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.
Daniels SE, Baum DR, Clark F, Golf MH, McDonnell ME, Boesing SE. Diclofenac potassium liquid-filled soft gelatin capsules for the treatment of postbunionectomy pain. Curr Med Res Opin. 2010 Oct;26(10):2375-84. doi: 10.1185/03007995.2010.515478.
Related Links
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Related Info
Other Identifiers
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XP21L-302
Identifier Type: -
Identifier Source: org_study_id