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Trial · NCT00694369

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

NCT00694369, Phase 3, Completed, Organon and Co; results first posted 2010-01-29

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study to Asses the Effect of MK0663 in the Treatment of Patients With Postoperative Dental Pain (0663-092). Trials, record NCT00694369. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00694369

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
A Study to Asses the Effect of MK0663 in the Treatment of Patients With Postoperative Dental Pain (0663-092)
NCT number
NCT00694369
Status
Completed
Phases
Phase 3
Enrollment
588 participants, actual
Lead sponsor
Organon and Co
Conditions
Postoperative Dental Pain
Interventions
Comparator: etoricoxib, Comparator: ibuprofen, Comparator: acetaminophen + codeine, Comparator: placebo
First posted
2008-06-10
Last updated
2022-02-09
Results first posted
2010-01-29

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryTotal Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6)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.
SecondaryPatient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study MedicationAt 24 hours post the initial Day 1 dose of the study medicationPatient'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.

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYTotal Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6)Over the first 6 hours post the initial Day 1 dose of the study medication
Full Analysis Set population (all randomized patients who received at least 1 dose of study treatment and had at least 1 post-baseline PR data over the first 6 hours). Observed PR was used up to rescue. Missing data was imputed by linear interpolation at time points before rescue, by last-observation-carried-forward at time points after rescue.
Units on a ScaleLEAST_SQUARES_MEAN
SECONDARYPatient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study MedicationAt 24 hours post the initial Day 1 dose of the study medication
Full Analysis Set population (all randomized patients who received at least 1 dose of study treatment and had at least 1 post-baseline assessment at 24 hours). Observed data was used. Forty patients were excluded from the analysis due to no measurement at 24 hours after the initial Day 1 dose.
ParticipantsNUMBER

Results by group30

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Total Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6)Placebo5.08Standard Error 0.86Units on a Scale
Total Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6)Etoricoxib 90 mg16.10Standard Error 0.42Units on a Scale
Total Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6)Etoricoxib 120 mg15.73Standard Error 0.59Units on a Scale
Total Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6)Ibuprofen 2400 mg15.67Standard Error 0.42Units on a Scale
Total Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6)Acetaminophen 2400 mg/Codeine 240 mg11.83Standard Error 0.74Units on a Scale
Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study MedicationPlaceboPoor19Participants
Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study MedicationEtoricoxib 90 mgPoor12Participants
Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study MedicationEtoricoxib 120 mgPoor7Participants
Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study MedicationIbuprofen 2400 mgPoor6Participants
Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study MedicationAcetaminophen 2400 mg/Codeine 240 mgPoor1Participants

Participant flow15

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDPlacebo46
Overall StudySTARTEDEtoricoxib 90 mg191
Overall StudySTARTEDEtoricoxib 120 mg97
Overall StudySTARTEDIbuprofen 2400 mg192
Overall StudySTARTEDAcetaminophen 2400 mg/Codeine 240 mg62
Overall StudyCOMPLETEDPlacebo45
Overall StudyCOMPLETEDEtoricoxib 90 mg188
Overall StudyCOMPLETEDEtoricoxib 120 mg95
Overall StudyCOMPLETEDIbuprofen 2400 mg189
Overall StudyCOMPLETEDAcetaminophen 2400 mg/Codeine 240 mg56

Adverse events450

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherLymphadenopathyBlood and lymphatic system disordersPlacebo046
otherLymphadenopathyBlood and lymphatic system disordersEtoricoxib 90 mg0191
otherLymphadenopathyBlood and lymphatic system disordersEtoricoxib 120 mg097
otherLymphadenopathyBlood and lymphatic system disordersIbuprofen 2400 mg0192
otherLymphadenopathyBlood and lymphatic system disordersAcetaminophen 2400 mg/Codeine 240 mg162
otherPalpitationsCardiac disordersPlacebo046
otherPalpitationsCardiac disordersEtoricoxib 90 mg1191
otherPalpitationsCardiac disordersEtoricoxib 120 mg097
otherPalpitationsCardiac disordersIbuprofen 2400 mg0192
otherPalpitationsCardiac disordersAcetaminophen 2400 mg/Codeine 240 mg062

Adverse event totals15

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityPlacebo
Total, all-cause mortalityEtoricoxib 90 mg
Total, all-cause mortalityEtoricoxib 120 mg
Total, all-cause mortalityIbuprofen 2400 mg
Total, all-cause mortalityAcetaminophen 2400 mg/Codeine 240 mg
Total, other adverse eventsPlacebo1246
Total, other adverse eventsEtoricoxib 90 mg54191
Total, other adverse eventsEtoricoxib 120 mg2897
Total, other adverse eventsIbuprofen 2400 mg57192
Total, other adverse eventsAcetaminophen 2400 mg/Codeine 240 mg3562

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
23247002DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00694369

GET https://conductscience.org/api/trials/v1/NCT00694369/results?page=2