PainPhase 4NCT00348491
Efficacy of Lumiracoxib in Relieving Moderate to Severe Post-dental Surgery Pain, Compared to Both Placebo and Celecoxib
A Phase 4 study testing Lumiracoxib in people with Pain, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This study will assess the safety and efficacy of lumiracoxib 400 mg in relieving moderate to severe post-dental surgery pain, compared to both placebo and celecoxib 400 mg. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Lumiracoxib
- How many people
- 364 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to May 2006
- 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 17 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Requiring extraction of two or more partially impacted or fully bony impacted third molars. At least one of the extractions must be mandibular
- Moderate to severe post-dental surgery pain intensity (as rated by the patient on the categorical pain intensity scale within five hours of surgery
Who cannot join
- Evidence or history of any cardiac and cerebral thrombotic/ ischemic diseases and/ or events
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Double-dummy, Parallel Group, Single-center Study Evaluating the Analgesic Effect of Single Doses of Lumiracoxib 400 mg, Celecoxib 400 mg and Placebo in the Treatment of Post-dental Surgery Pain
This study will assess the safety and efficacy of lumiracoxib 400 mg in relieving moderate to severe post-dental surgery pain, compared to both placebo and celecoxib 400 mg.
- Conditions
- Pain
- Being tested
- Lumiracoxib
- Keywords
- Dental surgery, acute pain, lumiracoxib, celecoxib, Moderate to severe pain following dental surgery
- Medical subject headings
- Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumiracoxibDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Superiority of a single dose of lumiracoxib 400 mg compared to placebo and celecoxib 400 mg based on a Summed (time weighted) Pain Intensity Difference calculated over 0-8 hours post-dose (SPID-8)
Secondary outcomes (3)
Evaluate efficacy of a single dose of lumiracoxib 400 mg compared to placebo and to celecoxib 400 mg in relieving post dental surgery pain with respect to the following secondary efficacy variables:
Time-specific Pain intensity Difference (PID) based on the categorical scale, Pain Relief (PR) based on the categorical scale, and Pain Relief Intensity Difference (PRID) (sum of PID and PR based on categorical scales) at time-points up to 24 hours after
Time-specific PID based on VAS at time-points up to 24 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startFeb 2006
- Primary completionMay 2006
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 PainStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 364 participants
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348491
- Sponsor's protocol ID
- CCOX189A2474
- Status last verified
- Feb 2017
- First submitted
- 30 Jun 2006
- Last updated
- 23 Feb 2017
- Results posted
- No
Publications
Fricke J, Davis N, Yu V, Krammer G. Lumiracoxib 400 mg compared with celecoxib 400 mg and placebo for treating pain following dental surgery: a randomized, controlled trial. J Pain. 2008 Jan;9(1):20-7. doi: 10.1016/j.jpain.2007.08.004. Epub 2007 Oct 15.
PubMed 17933588
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Double-dummy, Parallel Group, Single-center Study Evaluating the Analgesic Effect of Single Doses of Lumiracoxib 400 mg, Celecoxib 400 mg and Placebo in the Treatment of Post-dental Surgery Pain
- ClinicalTrials.gov ID
- NCT00348491
- Acronym / sponsor ID
- CCOX189A2474
- Conditions
- Pain
- Keywords
- Dental surgery, acute pain, lumiracoxib, celecoxib, Moderate to severe pain following dental surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 364 participants
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- May 2006 (actual)
- First posted
- 4 Jul 2006 (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.
This study will assess the safety and efficacy of lumiracoxib 400 mg in relieving moderate to severe post-dental surgery pain, compared to both placebo and celecoxib 400 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Requiring extraction of two or more partially impacted or fully bony impacted third molars. At least one of the extractions must be mandibular
- Moderate to severe post-dental surgery pain intensity (as rated by the patient on the categorical pain intensity scale within five hours of surgery
Key exclusion criteria (2 listed)
- Evidence or history of any cardiac and cerebral thrombotic/ ischemic diseases and/ or events
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| Lumiracoxib | Drug | – |
Primary outcome
Superiority of a single dose of lumiracoxib 400 mg compared to placebo and celecoxib 400 mg based on a Summed (time weighted) Pain Intensity Difference calculated over 0-8 hours post-dose (SPID-8)
3 secondary outcomes
Evaluate efficacy of a single dose of lumiracoxib 400 mg compared to placebo and to celecoxib 400 mg in relieving post dental surgery pain with respect to the following secondary efficacy variables:
Time-specific Pain intensity Difference (PID) based on the categorical scale, Pain Relief (PR) based on the categorical scale, and Pain Relief Intensity Difference (PRID) (sum of PID and PR based on categorical scales) at time-points up to 24 hours after
Time-specific PID based on VAS at time-points up to 24 hours after dosing
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 23 Feb 2017.
- Results publication: PubMed 17933588Fricke J, Davis N, Yu V, Krammer G. Lumiracoxib 400 mg compared with celecoxib 400 mg and placebo for treating pain following dental surgery: a randomized, controlled trial. J Pain. 2008 Jan;9(1):20-7. doi: 10.1016/j.jpain.2007.08.004. Epub 2007 Oct 15.
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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.
Novartis Pharmaceuticals study director
Novartis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lumiracoxib in people with Pain, run by Novartis Pharmaceuticals at 1 site in United States.
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 2 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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?
Superiority of a single dose of lumiracoxib 400 mg compared to placebo and celecoxib 400 mg based on a Summed (time weighted) Pain Intensity Difference calculated over 0-8 hours post-dose (SPID-8). 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 NCT00348491, 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 23 Feb 2017.