Postoperative Dental PainPhase 3NCT00694369
A Study to Asses the Effect of MK0663 in the Treatment of Patients With Postoperative Dental Pain (0663-092)
A Phase 3 study testing Comparator: etoricoxib, Comparator: ibuprofen and Comparator: acetaminophen + codeine in people with Postoperative Dental Pain, run by Organon and Co.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Dental Pain
- What is being tested?
- Comparator: etoricoxib, Comparator: ibuprofen and Comparator: acetaminophen + codeine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 588 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Jan 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous molar extraction within the past 45 days
- Personal or family history of an inherited bleeding disorder
- Uncontrolled high blood pressure
About this study
Official 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
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.
- Conditions
- Postoperative Dental Pain
- Being tested
- Comparator: etoricoxib, Comparator: ibuprofen, Comparator: acetaminophen + codeine, Comparator: placebo
- Keywords
- Postoperative Dental Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator: etoricoxibDrug
etoricoxib 90 mg; 120 mg (once daily) over three days.
Comparator: ibuprofenDrug
ibuprofen 2400 mg (600 mg Q6h) over three Days
Comparator: acetaminophen + codeineDrug
acetaminophen 2400 mg/codeine 240 mg (600/60 mg Q6h) over three Days
Comparator: placeboDrug
matching placebo over three Days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | etoricoxib 90 mg Receives: Drug: Comparator: etoricoxib |
| 2 | Experimental | etoricoxib 120 mg Receives: Drug: Comparator: etoricoxib |
| 3 | Active comparator | ibuprofen 2400 mg Receives: Drug: Comparator: ibuprofen |
| 4 | Active comparator | acetaminophen 2400 mg/codeine 240 mg Receives: Drug: Comparator: acetaminophen + codeine |
| 5 | Placebo comparator | Matching Placebo Receives: Drug: Comparator: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: At 24 hours post the initial Day 1 dose of the study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Dental PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 588 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694369
- Sponsor's protocol ID
- 0663-092
- Other IDs
- MK0663-092, 2008_506
- Status last verified
- Feb 2022
- First submitted
- 6 Jun 2008
- Last updated
- 9 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23247002
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00694369
- Acronym / sponsor ID
- 0663-092
- Conditions
- Postoperative Dental Pain
- Keywords
- Postoperative Dental Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 588 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 10 Jun 2008 (estimated)
- Results
- Posted 29 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Comparator: etoricoxibetoricoxib 90 mg |
| 2 | Experimental | Drug: Comparator: etoricoxibetoricoxib 120 mg |
| 3 | Active comparator | Drug: Comparator: ibuprofenibuprofen 2400 mg |
| 4 | Active comparator | Drug: Comparator: acetaminophen + codeineacetaminophen 2400 mg/codeine 240 mg |
| 5 | Placebo comparator | Drug: Comparator: placeboMatching Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Previous molar extraction within the past 45 days
- Personal or family history of an inherited bleeding disorder
- Uncontrolled high blood pressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparator: etoricoxibetoricoxib 90 mg; 120 mg (once daily) over three days. | Drug | 1, 2 |
| Comparator: ibuprofenibuprofen 2400 mg (600 mg Q6h) over three Days | Drug | 3 |
| Comparator: acetaminophen + codeineacetaminophen 2400 mg/codeine 240 mg (600/60 mg Q6h) over three Days | Drug | 4 |
| Comparator: placebomatching placebo over three Days | Drug | 5 |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23247002Brown 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.
Related trials for Postoperative Dental Pain
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Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
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Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
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A Study of CYT-1010 in Healthy Volunteers and Participants With Acute Pain After Third Molar Extraction
Acute Postoperative Pain, Dental Pain
Not yet recruiting
Effect of Intracanal Cryotherapy on Pain, Anxiety, and Salivary Irisin After Root Canal Treatment
Postoperative Pain After Endodontic Treatment, Dental Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Comparator: etoricoxib, Comparator: ibuprofen and Comparator: acetaminophen + codeine in people with Postoperative Dental Pain, run by Organon and Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00694369, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.