Post-operative Dental PainPhase 3NCT03566979
Efficacy and Safety Study of a Test Naproxen Sodium 220mg Tablet in Postoperative Dental Pain
A Phase 3 study testing Test naproxen sodium tablet, Commercial naproxen sodium tablet and Commercial naproxen sodium liquid gels capsule in people with Post-operative Dental Pain, run by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division at 1 site in United States.
Trial summary
To evaluate analgesic onset, efficacy, and safety of a single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets compared with two commercial naproxen sodium products (two naproxen sodium 220 mg tablets and two naproxen sodium 220 mg liquid gels capsules) and placebo in the… Read more about this study
- Who is it for?
- Ages 17 to 50 years
- Conditions the study is for
- Post-operative Dental Pain
- What is being tested?
- Test naproxen sodium tablet, Commercial naproxen sodium tablet and Commercial naproxen sodium liquid gels capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 501 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2018to 15 Apr 2019
- 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 17 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 17 - 50 years old
- Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5 to 30.4 (inclusive) at screening
- Dental extraction of three or four third molars
- Meets post-surgical pain
- Females of childbearing potential and males agree to contraceptive requirements of study
- Have a negative urine drug screen at screening, and on day of surgical procedure
Who cannot join
- Pregnant female, breastfeeding, trying to be pregnant or male with pregnant partner or partner currently trying to become pregnant
- Have a known allergy or hypersensitivity to naproxen or other NSAIDs, including aspirin, or to acetaminophen, hydrocodone or other opioids
- Not able to swallow large tablets or capsules
- History of any condition (s) in investigator's opinion, may jeopardize subject safety, well-being and integrity of study
- Use analgesics 5 or more times per week
- History of chronic tranquilizer use, heavy drinking, substance abuse as judged by investigator site staff within last 5 years
- Use of immunosuppressive drugs within 2 weeks of screening
- History of endoscopically documented peptic ulcer disease or bleeding disorder in last 2 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo- and Active- Controlled, Efficacy and Safety Study of a Test Naproxen Sodium 220 mg Tablet in Postoperative Dental Pain
To evaluate analgesic onset, efficacy, and safety of a single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets compared with two commercial naproxen sodium products (two naproxen sodium 220 mg tablets and two naproxen sodium 220 mg liquid gels capsules) and placebo in the dental pain model following third-molar extractions.
Read the detailed description
This is a single-dose, randomized, double-blind, placebo- and active- controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of 440 mg of naproxen sodium administered as two Test NPX 220 mg tablets compared with two commercial products and placebo over a twelve-hour period after third-molar extractions. Subjects will undergo dental extraction of three or four third molars.
- Conditions
- Post-operative Dental Pain
- Being tested
- Test naproxen sodium tablet, Commercial naproxen sodium tablet, Commercial naproxen sodium liquid gels capsule, Placebo tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test naproxen sodium tabletDrug
Also called Test NPX tablet
Single dose of 2 test naproxen sodium 220 mg tablets
Commercial naproxen sodium tabletDrug
Also called Commercial NPX tablet
Single dose of 2 naproxen sodium 220 mg tablets
Commercial naproxen sodium liquid gels capsuleDrug
Also called Commercial NPX liquid gels capsule
Single dose of 2 naproxen sodium 220 mg liquid gel capsules
Placebo tabletDrug
2 placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Test naproxen sodium tablet | Experimental | Single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets (Test NPX) Receives: Drug: Test naproxen sodium tablet |
| Commercial naproxen sodium tablet | Active comparator | Single dose of 440 mg of naproxen sodium administered as two commercial naproxen sodium 220 mg tablets Receives: Drug: Commercial naproxen sodium tablet |
| Commercial naproxen sodium liquid gels capsule | Active comparator | Single dose of 440 mg of naproxen sodium administered as two 220 mg commercial liquid gels capsules Receives: Drug: Commercial naproxen sodium liquid gels capsule |
| Placebo tablet | Placebo comparator | Single dose of two Placebo tablets Receives: Drug: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Confirmed Perceptible Pain Relief
Minutes until confirmed first perceptible pain relief was achieved. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The first perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief.
Measured: 12 hours
Secondary outcomes (1)
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
Percentage of participants with confirmed perceptible pain relief from 45 minutes to successively earlier minutes in one-minute increments were reported.
Measured: Up to 45 minutes after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start13 Aug 2018
- Primary completion26 Mar 2019
- Study completion15 Apr 2019
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.
- Other trials for Post-operative 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
- Model description
- Post-operative dental pain following third molar extraction.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Todd M Bertoch, MD, Principal investigator, JBR Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03566979
- Sponsor's protocol ID
- CCSPAA000457
- Status last verified
- Apr 2020
- First submitted
- 12 Jun 2018
- Last updated
- 9 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo- and Active- Controlled, Efficacy and Safety Study of a Test Naproxen Sodium 220 mg Tablet in Postoperative Dental Pain
- ClinicalTrials.gov ID
- NCT03566979
- Acronym / sponsor ID
- CCSPAA000457
- Conditions
- Post-operative Dental Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 26 Mar 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 25 Jun 2018 (actual)
- Results
- Posted 9 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate analgesic onset, efficacy, and safety of a single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets compared with two commercial naproxen sodium products (two naproxen sodium 220 mg tablets and two naproxen sodium 220 mg liquid gels capsules) and placebo in the dental pain model following third-molar extractions.
Detailed description
This is a single-dose, randomized, double-blind, placebo- and active- controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of 440 mg of naproxen sodium administered as two Test NPX 220 mg tablets compared with two commercial products and placebo over a twelve-hour period after third-molar extractions. Subjects will undergo dental extraction of three or four third molars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Post-operative dental pain following third molar extraction.
| Arm | Type | Receives |
|---|---|---|
| Test naproxen sodium tablet | Experimental | Drug: Test naproxen sodium tabletSingle dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets (Test NPX) |
| Commercial naproxen sodium tablet | Active comparator | Drug: Commercial naproxen sodium tabletSingle dose of 440 mg of naproxen sodium administered as two commercial naproxen sodium 220 mg tablets |
| Commercial naproxen sodium liquid gels capsule | Active comparator | Drug: Commercial naproxen sodium liquid gels capsuleSingle dose of 440 mg of naproxen sodium administered as two 220 mg commercial liquid gels capsules |
| Placebo tablet | Placebo comparator | Drug: Placebo tabletSingle dose of two Placebo tablets |
Who may qualify
- Ages
- 17 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 17 - 50 years old
- Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5 to 30.4 (inclusive) at screening
- Dental extraction of three or four third molars
- Meets post-surgical pain
- Females of childbearing potential and males agree to contraceptive requirements of study
Key exclusion criteria (8 listed)
- Pregnant female, breastfeeding, trying to be pregnant or male with pregnant partner or partner currently trying to become pregnant
- Have a known allergy or hypersensitivity to naproxen or other NSAIDs, including aspirin, or to acetaminophen, hydrocodone or other opioids
- Not able to swallow large tablets or capsules
- History of any condition (s) in investigator's opinion, may jeopardize subject safety, well-being and integrity of study
- Use analgesics 5 or more times per week
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 |
|---|---|---|
| Test naproxen sodium tabletAlso: Test NPX tabletSingle dose of 2 test naproxen sodium 220 mg tablets | Drug | Test naproxen sodium tablet |
| Commercial naproxen sodium tabletAlso: Commercial NPX tabletSingle dose of 2 naproxen sodium 220 mg tablets | Drug | Commercial naproxen sodium tablet |
| Commercial naproxen sodium liquid gels capsuleAlso: Commercial NPX liquid gels capsuleSingle dose of 2 naproxen sodium 220 mg liquid gel capsules | Drug | Commercial naproxen sodium liquid gels capsule |
| Placebo tablet2 placebo tablets | Drug | Placebo tablet |
Primary outcome
Time to Confirmed Perceptible Pain Relief
Time frame: 12 hours
Minutes until confirmed first perceptible pain relief was achieved. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The first perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief.
1 secondary outcome
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
Time frame: Up to 45 minutes after dosing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
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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.
Todd M Bertoch, MD principal investigator
JBR Clinical Research
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 Test naproxen sodium tablet, Commercial naproxen sodium tablet and Commercial naproxen sodium liquid gels capsule in people with Post-operative Dental Pain, run by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division 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 6 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: finished, as of the sponsor's last update on 9 Apr 2020. 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. 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 9 Apr 2020). 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?
Time to Confirmed Perceptible Pain Relief (time frame: 12 hours). 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 9 Apr 2020.