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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total 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. |
| Secondary | 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 | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total 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 Scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | 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. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6) | Placebo | 5.08 | Standard Error 0.86 | Units 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 mg | 16.10 | Standard Error 0.42 | Units 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 mg | 15.73 | Standard Error 0.59 | Units 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 mg | 15.67 | Standard Error 0.42 | Units 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 mg | 11.83 | Standard Error 0.74 | Units on a Scale | |
| Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study Medication | Placebo | Poor | 19 | Participants | |
| Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study Medication | Etoricoxib 90 mg | Poor | 12 | Participants | |
| Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study Medication | Etoricoxib 120 mg | Poor | 7 | Participants | |
| Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study Medication | Ibuprofen 2400 mg | Poor | 6 | Participants | |
| Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study Medication | Acetaminophen 2400 mg/Codeine 240 mg | Poor | 1 | Participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 46 | |
| Overall Study | STARTED | Etoricoxib 90 mg | 191 | |
| Overall Study | STARTED | Etoricoxib 120 mg | 97 | |
| Overall Study | STARTED | Ibuprofen 2400 mg | 192 | |
| Overall Study | STARTED | Acetaminophen 2400 mg/Codeine 240 mg | 62 | |
| Overall Study | COMPLETED | Placebo | 45 | |
| Overall Study | COMPLETED | Etoricoxib 90 mg | 188 | |
| Overall Study | COMPLETED | Etoricoxib 120 mg | 95 | |
| Overall Study | COMPLETED | Ibuprofen 2400 mg | 189 | |
| Overall Study | COMPLETED | Acetaminophen 2400 mg/Codeine 240 mg | 56 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events450
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Lymphadenopathy | Blood and lymphatic system disorders | Placebo | 0 | 46 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Etoricoxib 90 mg | 0 | 191 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Etoricoxib 120 mg | 0 | 97 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Ibuprofen 2400 mg | 0 | 192 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Acetaminophen 2400 mg/Codeine 240 mg | 1 | 62 | |
| other | Palpitations | Cardiac disorders | Placebo | 0 | 46 | |
| other | Palpitations | Cardiac disorders | Etoricoxib 90 mg | 1 | 191 | |
| other | Palpitations | Cardiac disorders | Etoricoxib 120 mg | 0 | 97 | |
| other | Palpitations | Cardiac disorders | Ibuprofen 2400 mg | 0 | 192 | |
| other | Palpitations | Cardiac disorders | Acetaminophen 2400 mg/Codeine 240 mg | 0 | 62 |
1 to 10 of 450Source ClinicalTrials.gov
See all 450 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Etoricoxib 90 mg | ||
| Total, all-cause mortality | Etoricoxib 120 mg | ||
| Total, all-cause mortality | Ibuprofen 2400 mg | ||
| Total, all-cause mortality | Acetaminophen 2400 mg/Codeine 240 mg | ||
| Total, other adverse events | Placebo | 12 | 46 |
| Total, other adverse events | Etoricoxib 90 mg | 54 | 191 |
| Total, other adverse events | Etoricoxib 120 mg | 28 | 97 |
| Total, other adverse events | Ibuprofen 2400 mg | 57 | 192 |
| Total, other adverse events | Acetaminophen 2400 mg/Codeine 240 mg | 35 | 62 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23247002 | DERIVED |
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.
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