NCT00092313

Brief Summary

The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
271

participants targeted

Target at P75+ for phase_3 postoperative-pain

Timeline
Completed

Started Jun 2002

Shorter than P25 for phase_3 postoperative-pain

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, 2002

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2002

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2004

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 27, 2004

Completed
Last Updated

November 25, 2015

Status Verified

November 1, 2015

Enrollment Period

3 months

First QC Date

September 22, 2004

Last Update Submit

November 24, 2015

Conditions

Postoperative Pain

Keywords

dental surgerymolar removal

Outcome Measures

Primary Outcomes (1)

  • Post-op dental pain over 6 hours as measured by pain intensity/relief scores, patient global assessment, and time to perceptible/meaningful pain relief.

Secondary Outcomes (1)

  • Time to onset of analgesic effect, peak analgesic effect, and/or duration of analgesic effect over 24 hours.

Interventions

MK0966, rofecoxibDRUG
Comparator: oxycodone and acetaminophenDRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Impaction of a molar tooth requiring removal

You may not qualify if:

  • Known allergy to the study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Chang DJ, Desjardins PJ, Bird SR, Black P, Chen E, Petruschke RA, Geba GP. Comparison of rofecoxib and a multidose oxycodone/ acetaminophen regimen for the treatment of acute pain following oral surgery: a randomized controlled trial. Curr Med Res Opin. 2004 Jun;20(6):939-49. doi: 10.1185/030079904125003863.

    PMID: 15200753BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

rofecoxibAcetaminophen

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

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

September 22, 2004

First Posted

September 27, 2004

Study Start

June 1, 2002

Primary Completion

September 1, 2002

Study Completion

September 1, 2002

Last Updated

November 25, 2015

Record last verified: 2015-11