A Study to Asses the Effect of MK0663 in the Treatment of Patients With Postoperative Dental Pain (0663-092)
NCT ID: NCT00694369
Last Updated: 2022-02-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
588 participants
INTERVENTIONAL
2008-06-30
2009-01-31
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
DOUBLE
Study Groups
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1
etoricoxib 90 mg
Comparator: etoricoxib
etoricoxib 90 mg; 120 mg (once daily) over three days.
2
etoricoxib 120 mg
Comparator: etoricoxib
etoricoxib 90 mg; 120 mg (once daily) over three days.
3
ibuprofen 2400 mg
Comparator: ibuprofen
ibuprofen 2400 mg (600 mg Q6h) over three Days
4
acetaminophen 2400 mg/codeine 240 mg
Comparator: acetaminophen + codeine
acetaminophen 2400 mg/codeine 240 mg (600/60 mg Q6h) over three Days
5
Matching Placebo
Comparator: placebo
matching placebo over three Days
Interventions
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Comparator: etoricoxib
etoricoxib 90 mg; 120 mg (once daily) over three days.
Comparator: ibuprofen
ibuprofen 2400 mg (600 mg Q6h) over three Days
Comparator: acetaminophen + codeine
acetaminophen 2400 mg/codeine 240 mg (600/60 mg Q6h) over three Days
Comparator: placebo
matching placebo over three Days
Eligibility Criteria
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Inclusion Criteria
* Patients must be experiencing moderate to severe pain following the dental procedure
Exclusion Criteria
* Personal or family history of an inherited bleeding disorder
* Uncontrolled high blood pressure
18 Years
ALL
No
Sponsors
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Organon and Co
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Brown JD, Daniels SE, Bandy DP, Ko AT, Gammaitoni A, Mehta A, Boice JA, Losada MC, Peloso PM. Evaluation of multiday analgesia with etoricoxib in a double-blind, randomized controlled trial using the postoperative third-molar extraction dental pain model. Clin J Pain. 2013 Jun;29(6):492-8. doi: 10.1097/AJP.0b013e318260c144.
Other Identifiers
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MK0663-092
Identifier Type: -
Identifier Source: secondary_id
2008_506
Identifier Type: -
Identifier Source: secondary_id
0663-092
Identifier Type: -
Identifier Source: org_study_id
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