Dental PainPhase 3NCT00114049
Dental Pain (Following Third Molar Tooth Extraction) Study
A Phase 3 study testing GW406381 in people with Dental Pain and Surgery, Dental, run by GlaxoSmithKline at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of GW406381 (a COX-2 inhibitor) in treating the signs and symptoms of dental pain following third molar tooth extraction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Pain, Surgery, Dental
- What is being tested?
- GW406381
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Apr 2005
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for outpatient surgical removal of at least two third molar teeth.
Who cannot join
- Subjects who do not achieve moderate to severe pain.
- Subjects who do not use acceptable contraception.
- Additional medical criteria will be assessed by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pivotal Phase III, Single Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Dose-Ranging Study to Investigate the Efficacy and Safety of Single Oral Doses of 10mg, 25mg, 50mg and 70mg GW406381 and 550mg Naproxen Sodium in Subjects With Pain Following Third Molar Tooth Extraction
The purpose of this study is to evaluate the effectiveness of GW406381 (a COX-2 inhibitor) in treating the signs and symptoms of dental pain following third molar tooth extraction.
Read the detailed description
A Pivotal Phase III, Single Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Dose-Ranging Study to Investigate the Efficacy and Safety of Single Oral Doses of 10mg, 25mg, 50mg, and 70mg GW406381 and 550mg Naproxen Sodium in Subjects With Pain Following Third Molar Tooth Extraction
- Conditions
- Dental Pain, Surgery, Dental
- Being tested
- GW406381
- Keywords
- Dental Pain, Dental Surgery, Cox-2 inhibitor
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW406381Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between treatments over time based on pain intensity and pain relief scores.
Secondary outcomes (1)
Difference between treatments based on changes in onset, duration of activity, overall effectiveness, and patient based assessments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2005 (estimated)
- Study startDec 2004
- Primary completionApr 2005
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PainStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00114049
- Sponsor's protocol ID
- CXA30001
- Status last verified
- Jan 2017
- First submitted
- 13 Jun 2005
- Last updated
- 19 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Phase III, Single Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Dose-Ranging Study to Investigate the Efficacy and Safety of Single Oral Doses of 10mg, 25mg, 50mg and 70mg GW406381 and 550mg Naproxen Sodium in Subjects With Pain Following Third Molar Tooth Extraction
- ClinicalTrials.gov ID
- NCT00114049
- Acronym / sponsor ID
- CXA30001
- Conditions
- Dental Pain, Surgery, Dental
- Keywords
- Dental Pain, Dental Surgery, Cox-2 inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 14 Jun 2005 (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 evaluate the effectiveness of GW406381 (a COX-2 inhibitor) in treating the signs and symptoms of dental pain following third molar tooth extraction.
Detailed description
A Pivotal Phase III, Single Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Dose-Ranging Study to Investigate the Efficacy and Safety of Single Oral Doses of 10mg, 25mg, 50mg, and 70mg GW406381 and 550mg Naproxen Sodium in Subjects With Pain Following Third Molar Tooth Extraction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled for outpatient surgical removal of at least two third molar teeth.
Key exclusion criteria (3 listed)
- Subjects who do not achieve moderate to severe pain.
- Subjects who do not use acceptable contraception.
- Additional medical criteria will be assessed by the investigator.
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 |
|---|---|---|
| GW406381 | Drug | – |
Primary outcome
Difference between treatments over time based on pain intensity and pain relief scores.
1 secondary outcome
Difference between treatments based on changes in onset, duration of activity, overall effectiveness, and patient based assessments.
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 19 Jan 2017.
Related trials for Dental Pain
RecruitingPhase 1/2
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
Recruiting
Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
Pulp Necrosis, Apical Periodontitis
Recruiting
Buzzy Bee for Pain and Anxiety Control During Pediatric Dental Local Anesthesia
Anesthesia, Anxiety
Not yet recruiting
Photobiomodulation After Nonsurgical Root Canal Treatment
Symptomatic Apical Periodontitis, Postoperative Pain
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.
GSK Clinical Trials, MD study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GW406381 in people with Dental Pain and Surgery, Dental, run by GlaxoSmithKline 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 1 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 19 Jan 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 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?
Difference between treatments over time based on pain intensity and pain relief scores.. 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 19 Jan 2017.