Postoperative PainPhase 3NCT00092300
A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-181)(COMPLETED)
A Phase 3 study testing MK0966, rofecoxib and Comparator: valdecoxib in people with Postoperative Pain, run by Merck Sharp & Dohme LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- MK0966, rofecoxib and Comparator: valdecoxib
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- May 2002to Sep 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Impaction of a molar tooth requiring removal
Who cannot join
- Known allergies to the study drug
About this study
Official title: A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled, Single Dose Study of the Effect of Rofecoxib 50 mg and Valdecoxib 20 mg in Patients With Postoperative Dental Pain
The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.
Read the detailed description
The duration of treatment is 1 day.
- Conditions
- Postoperative Pain
- Being tested
- MK0966, rofecoxib, Comparator: valdecoxib
- Keywords
- dental surgery, molar removal
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0966, rofecoxibDrug
Comparator: valdecoxibDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall analgesic effect over 12 hours.
Secondary outcomes (4)
Overall analgesic effect over 8 hours.
Time to onset of analgesic, peak analgesic and duration of analgesic effects.
Overall analgesic, time to onset of analgesic, peak analgesic, and duration analgesic effects
Safety and tolerability.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2004 (estimated)
- Study startMay 2002
- Primary completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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
- 450 participants
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- 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
- NCT00092300
- Sponsor's protocol ID
- 0966-181
- Other IDs
- 2004_066
- Status last verified
- Jul 2015
- First submitted
- 22 Sep 2004
- Last updated
- 4 Aug 2015
- Results posted
- No
Publications
Daniels SE, Desjardins PJ, Bird SR, Smugar SS, Tershakovec AM. Rofecoxib 50 mg and valdecoxib 20 or 40 mg in adults and adolescents with postoperative pain after third molar extraction: results of two randomized, double-blind, placebo-controlled, single-dose studies. Clin Ther. 2006 Jul;28(7):1022-34. doi: 10.1016/j.clinthera.2006.07.005.
PubMed 16990080
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled, Single Dose Study of the Effect of Rofecoxib 50 mg and Valdecoxib 20 mg in Patients With Postoperative Dental Pain
- ClinicalTrials.gov ID
- NCT00092300
- Acronym / sponsor ID
- 0966-181
- Conditions
- Postoperative Pain
- Keywords
- dental surgery, molar removal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Primary completion
- Sep 2002 (actual)
- First posted
- 28 Sep 2004 (estimated)
- Results
- Not posted in the source record
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 safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.
Detailed description
The duration of treatment is 1 day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Impaction of a molar tooth requiring removal
Key exclusion criteria (1 listed)
- Known allergies to the study drug
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 |
|---|---|---|
| MK0966, rofecoxib | Drug | – |
| Comparator: valdecoxib | Drug | – |
Primary outcome
Overall analgesic effect over 12 hours.
4 secondary outcomes
Overall analgesic effect over 8 hours.
Time to onset of analgesic, peak analgesic and duration of analgesic effects.
Overall analgesic, time to onset of analgesic, peak analgesic, and duration analgesic effects
Safety and tolerability.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2015.
- Background: PubMed 16990080Daniels SE, Desjardins PJ, Bird SR, Smugar SS, Tershakovec AM. Rofecoxib 50 mg and valdecoxib 20 or 40 mg in adults and adolescents with postoperative pain after third molar extraction: results of two randomized, double-blind, placebo-controlled, single-dose studies. Clin Ther. 2006 Jul;28(7):1022-34. doi: 10.1016/j.clinthera.2006.07.005.
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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 MK0966, rofecoxib and Comparator: valdecoxib in people with Postoperative Pain, run by Merck Sharp & Dohme LLC.
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 1 inclusion and 1 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 4 Aug 2015. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall analgesic effect over 12 hours.. 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 NCT00092300, 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 4 Aug 2015.