Dental ExtractionPhase 4NCT00855777
Etoricoxib Versus Ibuprofen in Third Molar Extraction Pain
A Phase 4 study testing etoricoxib and ibuprofen in people with Dental Extraction, run by Universita di Verona.
Trial summary
The aim of this study is to evaluate the analgesic efficacy of etoricoxib compared with a well known and widely used non-steroid antinflammatory drug, ibuprofen, in third molar extraction pain. At this time, there are no data about the efficacy of etoricoxib for reducing pain following dental extraction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Extraction
- What is being tested?
- etoricoxib and ibuprofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Apr 2010
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects with age > 18 years
- in good health status (assessed in occasion of enrollment visit) without any major systemic illness
- candidate to third molar extraction and presenting local pain within 2 hours after dental extraction
Who cannot join
- patients with any major systemic illness
- patients with a clinical history of drug abuse
- patients with hypertension and/or a condition of increased cardiovascular risk
- pregnant or lactating women
- patients with a history of hypersensitivity/allergy to analgesic drugs, including classical NSAID or coxibs
- patients with either high levels of liver enzymes (major of 1.5x the upper limit of reference interval) or of creatinine(major of 1.2x the upper limit of reference interval)
- patients with either a history of peptic ulcer or of haemorrhagic diathesis
- patients who can not ensure an adequate compliance for the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Analgesic Efficacy of Etoricoxib Compared With Ibuprofen in Third Molar Extraction Pain.
The aim of this study is to evaluate the analgesic efficacy of etoricoxib compared with a well known and widely used non-steroid antinflammatory drug, ibuprofen, in third molar extraction pain. At this time, there are no data about the efficacy of etoricoxib for reducing pain following dental extraction.
This will be a single center, randomized, double-blind study, in which patients with moderate to severe pain following third molar extraction will be randomized to receive etoricoxib (120 mg in a single dose + 2 dose of placebo pro day for 3 days) or ibuprofen (1800 mg in 3 doses pro day for 3 days). Paracetamol plus codeine will be used as rescue medication. Pain assessment will be performed using a 11-point pain intensity scale (0 = no pain and 10 = worster pain) during the first 3 days after dental extraction. Patients will be enrolled 15 days before the dental extraction. During enrollment visit a complete clinical evaluation with particular attention for potential exclusion criteria (e.g. hypertension and cardiovascular risk factors) as well as blood analyses will be performed. A follow-up visit will be performed 15 days after the dental extraction. Tolerability will be assessed through recording of adverse events.
- Conditions
- Dental Extraction
- Being tested
- etoricoxib, ibuprofen
- Keywords
- third molar extraction, etoricoxib, ibuprofen, analgesic efficacy, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etoricoxibDrug
etoricoxib 120 mg/day for 3 days
ibuprofenDrug
ibuprofen 1,800 mg/day for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Etoricoxib | Experimental | Etoricoxib 120 mg/day x 3 days Receives: Drug: etoricoxib |
| Ibuprofen | Active comparator | Ibuprofen 1800 mg/day x 3 days Receives: Drug: ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
analgesic efficacy
Measured: 3 days
Secondary outcomes (1)
side effects
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2009 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ExtractionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Investigators
- Roberto Corrocher, MD, Study director, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855777
- Sponsor's protocol ID
- University of Verona - CE1597
- Status last verified
- Mar 2009
- First submitted
- 3 Mar 2009
- Last updated
- 4 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Analgesic Efficacy of Etoricoxib Compared With Ibuprofen in Third Molar Extraction Pain.
- ClinicalTrials.gov ID
- NCT00855777
- Acronym / sponsor ID
- University of Verona - CE1597
- Conditions
- Dental Extraction
- Keywords
- third molar extraction, etoricoxib, ibuprofen, analgesic efficacy, pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 4 Mar 2009 (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 aim of this study is to evaluate the analgesic efficacy of etoricoxib compared with a well known and widely used non-steroid antinflammatory drug, ibuprofen, in third molar extraction pain. At this time, there are no data about the efficacy of etoricoxib for reducing pain following dental extraction.
This will be a single center, randomized, double-blind study, in which patients with moderate to severe pain following third molar extraction will be randomized to receive etoricoxib (120 mg in a single dose + 2 dose of placebo pro day for 3 days) or ibuprofen (1800 mg in 3 doses pro day for 3 days). Paracetamol plus codeine will be used as rescue medication. Pain assessment will be performed using a 11-point pain intensity scale (0 = no pain and 10 = worster pain) during the first 3 days after dental extraction. Patients will be enrolled 15 days before the dental extraction. During enrollment visit a complete clinical evaluation with particular attention for potential exclusion criteria (e.g. hypertension and cardiovascular risk factors) as well as blood analyses will be performed. A follow-up visit will be performed 15 days after the dental extraction. Tolerability will be assessed through recording of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etoricoxib | Experimental | Drug: etoricoxibEtoricoxib 120 mg/day x 3 days |
| Ibuprofen | Active comparator | Drug: ibuprofenIbuprofen 1800 mg/day x 3 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- subjects with age > 18 years
- in good health status (assessed in occasion of enrollment visit) without any major systemic illness
- candidate to third molar extraction and presenting local pain within 2 hours after dental extraction
Key exclusion criteria (8 listed)
- patients with any major systemic illness
- patients with a clinical history of drug abuse
- patients with hypertension and/or a condition of increased cardiovascular risk
- pregnant or lactating women
- patients with a history of hypersensitivity/allergy to analgesic drugs, including classical NSAID or coxibs
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 |
|---|---|---|
| etoricoxibetoricoxib 120 mg/day for 3 days | Drug | Etoricoxib |
| ibuprofenibuprofen 1,800 mg/day for 3 days | Drug | Ibuprofen |
Primary outcome
analgesic efficacy
Time frame: 3 days
1 secondary outcome
side effects
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2009.
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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.
Roberto Corrocher, MD study director
Universita di Verona
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing etoricoxib and ibuprofen in people with Dental Extraction, run by Universita di Verona.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 4 Mar 2009. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberto Corrocher, MD (+39-045-8124401, roberto.corrocher@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
analgesic efficacy (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2009.