NCT00694369

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
588

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 10, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 29, 2010

Completed
Last Updated

February 9, 2022

Status Verified

February 1, 2022

Enrollment Period

6 months

First QC Date

June 6, 2008

Results QC Date

November 13, 2009

Last Update Submit

February 7, 2022

Conditions

Postoperative Dental Pain

Keywords

Postoperative Dental Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    At 24 hours post the initial Day 1 dose of the study medication

Study Arms (5)

1

EXPERIMENTAL

etoricoxib 90 mg

Drug: Comparator: etoricoxib

2

EXPERIMENTAL

etoricoxib 120 mg

Drug: Comparator: etoricoxib

3

ACTIVE COMPARATOR

ibuprofen 2400 mg

Drug: Comparator: ibuprofen

4

ACTIVE COMPARATOR

acetaminophen 2400 mg/codeine 240 mg

Drug: Comparator: acetaminophen + codeine

5

PLACEBO COMPARATOR

Matching Placebo

Drug: Comparator: placebo

Interventions

Comparator: etoricoxibDRUG

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

12
Comparator: ibuprofenDRUG

ibuprofen 2400 mg (600 mg Q6h) over three Days

3
Comparator: acetaminophen + codeineDRUG

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

4
Comparator: placeboDRUG

matching placebo over three Days

5

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 23247002DERIVED

MeSH Terms

Interventions

Codeine

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2008

First Posted

June 10, 2008

Study Start

June 1, 2008

Primary Completion

December 1, 2008

Study Completion

January 1, 2009

Last Updated

February 9, 2022

Results First Posted

January 29, 2010

Record last verified: 2022-02