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Completed

NCT Number: NCT00694369

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

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.

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Key information

Conditions

Postoperative Dental Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparator: etoricoxib

Drug

etoricoxib 90 mg; 120 mg (once daily) over three days.

Comparator: ibuprofen

Drug

ibuprofen 2400 mg (600 mg Q6h) over three Days

Comparator: acetaminophen + codeine

Drug

acetaminophen 2400 mg/codeine 240 mg (600/60 mg Q6h) over three Days

Comparator: placebo

Drug

matching placebo over three Days

Primary outcomes

  1. Total Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6)

    Time frame: Over the first 6 hours post the initial Day 1 dose of the study medication

    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.

Secondary outcomes

  1. Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study Medication

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Jun 10, 2008
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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