A Study to Asses the Effect of MK0663 in the Treatment of Patients With Postoperative Dental Pain (0663-092)

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Dental Pain
• Intervention / Treatment: Drug: Comparator: etoricoxib; Drug: Comparator: ibuprofen; Drug: Comparator: acetaminophen + codeine; Drug: Comparator: placebo

• Study Type: Interventional
• Enrollment (Actual): 588
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 5; Matching Placebo	Drug: Comparator: placebo; matching placebo over three Days
EXPERIMENTAL: 1; etoricoxib 90 mg	Drug: Comparator: etoricoxib; etoricoxib 90 mg; 120 mg (once daily) over three days.
EXPERIMENTAL: 2; etoricoxib 120 mg	Drug: Comparator: etoricoxib; etoricoxib 90 mg; 120 mg (once daily) over three days.
ACTIVE_COMPARATOR: 3; ibuprofen 2400 mg	Drug: Comparator: ibuprofen; ibuprofen 2400 mg (600 mg Q6h) over three Days
ACTIVE_COMPARATOR: 4; acetaminophen 2400 mg/codeine 240 mg	Drug: Comparator: acetaminophen + codeine; acetaminophen 2400 mg/codeine 240 mg (600/60 mg Q6h) over three Days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6)	TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point Likert scale, with 0=None, and 4=Complete for pain relief) at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours post the initial Day 1 dose. The range of TOPAR6 score is 0 to 24.	Over the first 6 hours post the initial Day 1 dose of the study medication

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study Medication	Patient's Global Assessment of Study Medication was on 0- to 4- point scale, with 0=Poor, and 4=Excellent for patient's rating of the study medication for pain.	At 24 hours post the initial Day 1 dose of the study medication

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (ACTUAL): December 1, 2008
• Study Completion (ACTUAL): January 1, 2009

Study Registration Dates

• First Submitted: June 6, 2008
• First Submitted That Met QC Criteria: June 9, 2008
• First Posted (ESTIMATE): June 10, 2008

Study Record Updates

• Last Update Posted (ACTUAL): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Postoperative Dental Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Facial Pain; Toothache; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Respiratory System Agents; Cyclooxygenase 2 Inhibitors; Antitussive Agents; Acetaminophen; Ibuprofen; Codeine; Etoricoxib
• Other Study ID Numbers: 0663-092; MK0663-092; 2008_506