A Study to Asses the Effect of MK0663 in the Treatment of Patients With Postoperative Dental Pain - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00694369

Purpose

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
Pain	Drug: etoricoxib Drug: ibuprofen Drug: acetaminophen (+) codeine Drug: placebo (unspecified)	Phase III

Drug Information available for: Ibuprofen Dexibuprofen Acetaminophen Etoricoxib Codeine Codeine phosphate

U.S. FDA Resources

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

Further study details as provided by Merck:

Primary Outcome Measures:

Safety and tolerability of MK0663 and overall analgesic effect as measured by the total pain relief score (TOPAR) [ Time Frame: Over the 6 hour post dose period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Global assessment of satisfaction with study drug [ Time Frame: Over the 24 hour post dose period ] [ Designated as safety issue: No ]

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
1: Experimental etoricoxib 90 mg	Drug: etoricoxib etoricoxib 90 mg; 120 mg (once daily) over three days.
2: Experimental etoricoxib 120 mg	Drug: etoricoxib etoricoxib 90 mg; 120 mg (once daily) over three days.
3: Active Comparator ibuprofen 2400 mg	Drug: ibuprofen ibuprofen 2400 mg (600 mg Q6h) over three Days
4: Active Comparator acetaminophen 2400 mg/codeine 240 mg	Drug: acetaminophen (+) codeine acetaminophen 2400 mg/codeine 240 mg (600/60 mg Q6h) over three Days
5: Placebo Comparator Matching Placebo	Drug: placebo (unspecified) matching placebo over three Days

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must be scheduled to have 2 or more third molars removed, at least 1 of which is partially embedded in bone and is impacted in the lower jaw
Patients must be experiencing moderate to severe pain following the dental procedure

Exclusion Criteria:

Previous molar extraction within the past 45 days
Personal or family history of an inherited bleeding disorder
Uncontrolled high blood pressure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694369

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

United States, Texas
Call for Information	Recruiting
Austin, Texas, United States, 78705-0000

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

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

Keywords provided by Merck:

Postoperative Dental Pain

Study placed in the following topic categories:

Tooth Diseases
Ibuprofen
Facial Pain
Facies
Toothache
Etoricoxib
Pain
Codeine

Naphazoline
Oxymetazoline
Signs and Symptoms
Guaifenesin
Phenylephrine
Phenylpropanolamine
Stomatognathic Diseases
Acetaminophen

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 16, 2009