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

Organon

Status and phase: Completed; Phase 3

Conditions: Postoperative Dental Pain

Treatments: Drug: Comparator: acetaminophen + codeine; Drug: Comparator: ibuprofen; Drug: Comparator: etoricoxib; Drug: Comparator: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00694369

0663-092

2008_506

MK0663-092

Details and patient eligibility

About

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.

Enrollment: 588 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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588 participants in 5 patient groups, including a placebo group

1

Experimental group

Description:

etoricoxib 90 mg

Treatment:

Drug: Comparator: etoricoxib

2

Experimental group

Description:

etoricoxib 120 mg

Treatment:

Drug: Comparator: etoricoxib

3

Active Comparator group

Description:

ibuprofen 2400 mg

Treatment:

Drug: Comparator: ibuprofen

4

Active Comparator group

Description:

acetaminophen 2400 mg/codeine 240 mg

Treatment:

Drug: Comparator: acetaminophen + codeine

5

Placebo Comparator group

Description:

Matching Placebo

Treatment:

Drug: Comparator: placebo