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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00694369 |
The purpose of this study is to compare the pain relieving effect of different doses of MK0663 with placebo and other pain relievers/analgesics in patients with postoperative dental pain. Pain intensity and relief will be measured by the total pain relief score (TOPAR) and patient evaluation.
Condition | Intervention | Phase |
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Pain |
Drug: etoricoxib Drug: ibuprofen Drug: acetaminophen (+) codeine Drug: placebo (unspecified) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Multiple-Dose Clinical Trial to Study the Efficacy and Safety of MK0663/Etoricoxib 90 and 120 mg, Ibuprofen 600 mg, and Acetaminophen 600 mg/Codeine 60 mg in the Treatment of Patients With Postoperative Dental Pain |
Estimated Enrollment: | 460 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
etoricoxib 90 mg
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Drug: etoricoxib
etoricoxib 90 mg; 120 mg (once daily) over three days.
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2: Experimental
etoricoxib 120 mg
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Drug: etoricoxib
etoricoxib 90 mg; 120 mg (once daily) over three days.
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3: Active Comparator
ibuprofen 2400 mg
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Drug: ibuprofen
ibuprofen 2400 mg (600 mg Q6h) over three Days
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4: Active Comparator
acetaminophen 2400 mg/codeine 240 mg
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Drug: acetaminophen (+) codeine
acetaminophen 2400 mg/codeine 240 mg (600/60 mg Q6h) over three Days
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5: Placebo Comparator
Matching Placebo
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Drug: placebo (unspecified)
matching placebo over three Days
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Toll Free Number | 1-888-577-8839 |
United States, Texas | |
Call for Information | Recruiting |
Austin, Texas, United States, 78705-0000 |
Study Director: | Medical Monitor | Merck |
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2008_506, MK0663-092 |
Study First Received: | June 6, 2008 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00694369 |
Health Authority: | United States: Food and Drug Administration |
Postoperative Dental Pain |
Tooth Diseases Ibuprofen Facial Pain Facies Toothache Etoricoxib Pain Codeine |
Naphazoline Oxymetazoline Signs and Symptoms Guaifenesin Phenylephrine Phenylpropanolamine Stomatognathic Diseases Acetaminophen |
Anti-Inflammatory Agents Respiratory System Agents Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Physiological Effects of Drugs Central Nervous System Depressants Enzyme Inhibitors Narcotics Pharmacologic Actions Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Antitussive Agents Central Nervous System Agents Analgesics, Opioid |