Efficacy and Safety of Diclofenac Potassium 25 mg Tablet Taken Three Times Daily in Subjects With Acute Joint Pain
NCT ID: NCT01666197
Last Updated: 2014-04-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2012-08-31
2013-01-31
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
QUADRUPLE
Study Groups
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diclofenac potassium 25 mg tablet
diclofenac potassium 25 mg tablet
diclofenac potassium 25 mg tablet
placebo
placebo
placebo
Interventions
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diclofenac potassium 25 mg tablet
diclofenac potassium 25 mg tablet
placebo
placebo
Eligibility Criteria
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Inclusion Criteria
* Acute sprain of the lateral ankle, Grade I-II, meeting baseline pain intensity level.
* Injury within past 12 hours.
Exclusion Criteria
* During the past 3 months: Grade I-III sprain of the same ankle.
* During the past 6 months: Grade II-III sprain, any other significant injury (such as fracture or torn ligament), or surgery (except for skin or nails) of the same ankle or foot.
* Pain or instability in the same ankle attributable to previous ankle sprain or any other trauma.
* Ankle sprain attributable to a known disease affecting the ligaments, such as ligament hyperlaxity due to connective tissue disease (e.g., Marfan's syndrome, Down's syndrome, Ehlers-Danlos syndrome).
18 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Locations
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Investigator
Brühl, , Germany
Investigator
Cologne, , Germany
Investigator
Essen, , Germany
Investigator
Gilching, , Germany
Countries
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Other Identifiers
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853-P-401
Identifier Type: -
Identifier Source: org_study_id
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