Post Operative Dental PainPhase 3NCT02735122
Study of Acetaminophen (ACM) in Post-operative Dental Pain
A Phase 3 study testing acetaminophen Tablet, acetaminophen Caplet and ibuprofen Liquid-filled 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
This is a Dental Pain Study which will evaluate the analgesic onset, efficacy and safety of 1000 mg acetaminophen as two Test acetaminophen 500 mg tablets, compared with commercial products of acetaminophen 1000 mg administered as two 500 mg caplets, and ibuprofen (IBU) 400 mg following third molar (wisdom tooth)… 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?
- acetaminophen Tablet, acetaminophen Caplet and ibuprofen Liquid-filled capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2016to 5 Oct 2016
- 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 17 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 17 years to 50 years old
- Weight 100 lbs or greater with a body mass index (BMI) 18-30 inclusive
- Dental extraction of three or four molars
- Experience moderate to severe pain after extraction of third molars
- Females of childbearing age must be willing to use acceptable method of birth control
Who cannot join
- Currently pregnant or planning to be pregnant or nursing a baby
- Known allergy to acetaminophen (ACM) or non-steroidal anti-inflammatory drugs (NSAIDS)
- Inability to swallow whole large tablets or capsules
- Have other conditions that the investigator feels may impact subject's safety and/or the integrity of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo- and Active- Controlled, Single-Dose, Efficacy, Safety, and Pharmacokinetics Study of a Test Acetaminophen 500 mg Tablet in Postoperative Dental Pain
This is a Dental Pain Study which will evaluate the analgesic onset, efficacy and safety of 1000 mg acetaminophen as two Test acetaminophen 500 mg tablets, compared with commercial products of acetaminophen 1000 mg administered as two 500 mg caplets, and ibuprofen (IBU) 400 mg following third molar (wisdom tooth) extraction.
Read the detailed description
This is a single-dose, randomized, double-blind, triple-dummy, placebo- and active controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of Test acetaminophen 1000 mg compared with two commercial products over a six-hour period after third-molar extractions. Subjects will undergo dental extraction of three or four third molars.
- Conditions
- Post Operative Dental Pain
- Being tested
- acetaminophen Tablet, acetaminophen Caplet, ibuprofen Liquid-filled capsule, Placebo Tablet, Placebo Caplet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetaminophen TabletDrug
Also called Test ACM
2 test acetaminophen 500 mg tablets
acetaminophen CapletDrug
Also called Commercial ACM
2 commercial acetaminophen 500 mg caplets
ibuprofen Liquid-filled capsuleDrug
Also called Commercial IBU
2 commercial ibuprofen 200 mg Liquid-filled capsules
Placebo TabletDrug
2 placebo tablets
Placebo CapletDrug
2 placebo caplets
Placebo Liquid-filled capsuleDrug
2 placebo Liquid-filled capsules
| Study group | Role | What they receive |
|---|---|---|
| Test acetaminophen | Experimental | acetaminophen tablet and placebo caplet and placebo liquid-filled capsule Receives: Drug: acetaminophen Tablet; Drug: Placebo Caplet; Drug: Placebo Liquid-filled capsule |
| Commercial acetaminophen | Active comparator | acetaminophen caplet and placebo tablet and placebo liquid-filled capsule Receives: Drug: acetaminophen Caplet; Drug: Placebo Tablet; Drug: Placebo Liquid-filled capsule |
| Commercial ibuprofen | Active comparator | ibuprofen liquid-filled capsule and placebo tablet and placebo caplet Receives: Drug: ibuprofen Liquid-filled capsule; Drug: Placebo Tablet; Drug: Placebo Caplet |
| Placebo | Placebo comparator | Placebo tablet and placebo caplet and placebo liquid-filled capsule Receives: Drug: Placebo Tablet; Drug: Placebo Caplet; Drug: Placebo Liquid-filled capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first confirmed perceptible pain relief
Minutes until confirmed first perceptible pain relief are achieved. Stopwatch is started after the subject takes the study medication. The subject is instructed to stop the stopwatch when they first begin to feel any pain relief. The first perceptible pain relief is confirmed if the subject also stopped the second stopwatch indicating meaningful pain relief.
Measured: 6 hours
Secondary outcomes (6)
Percentage of subjects with confirmed perceptible relief from 30 minutes to successively earlier minutes in one-minute increments (Test ACM versus placebo)
Measured: 30 minutes or less
Risk ratios of confirmed perceptible relief by 10 minutes (Test acetominophen and commercial ibuprofen)
The risk ratios and confidence intervals for incidence of confirmed perceptible relief of Test ACM divided by commercial IBU will be presented for 10 minutes
Measured: 10 minutes or less
Risk ratios of confirmed perceptible relief by 15 minutes (Test acetominophen and commercial ibuprofen)
The risk ratios and confidence intervals for incidence of confirmed perceptible relief of Test ACM divided by commercial IBU will be presented for 15 minutes
Measured: 15 minutes or less
Risk ratios of confirmed perceptible relief by 20 minutes (Test acetominophen and commercial ibuprofen)
The risk ratios and confidence intervals for incidence of confirmed perceptible relief of Test ACM divided by commercial IBU will be presented for 20 minutes
Measured: 20 minutes or less
Percentage of subjects with meaningful relief by 30 minutes
Measured: 30 minutes or less
Time to meaningful pain relief
Minutes until meaningful pain relief are achieved. Stopwatch is started after the subject takes the study medication. The subjects are instructed to stop the stopwatch when the relief from the starting pain is meaningful to them.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study start30 Apr 2016
- Primary completion5 Oct 2016
- Study completion5 Oct 2016
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 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Consumer and Personal Products Worldwide
- Responsible party
- Sponsor
- Investigators
- Derek D. Muse, M.D., Principal investigator, Jean Brown Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735122
- Sponsor's protocol ID
- CO-151027203834-PACT
- Status last verified
- Sep 2022
- First submitted
- 31 Mar 2016
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: At this time we do plan to share IPD through the YODA site. The specific individual participant data sets have not yet been determined.
Publications
Myers A, Gelotte C, Zuckerman A, Zimmerman B, Shenoy A, Qi D, Cooper SA. Analgesic onset and efficacy of a fast-acting formulation of acetaminophen in a postoperative dental impaction pain model. Curr Med Res Opin. 2024 Feb;40(2):267-277. doi: 10.1080/03007995.2023.2294946. Epub 2024 Jan 24.
PubMed 38124555
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo- and Active- Controlled, Single-Dose, Efficacy, Safety, and Pharmacokinetics Study of a Test Acetaminophen 500 mg Tablet in Postoperative Dental Pain
- ClinicalTrials.gov ID
- NCT02735122
- Acronym / sponsor ID
- CO-151027203834-PACT
- Conditions
- Post Operative Dental Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionIndustry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Consumer and Personal Products Worldwide
- Study start
- 30 Apr 2016 (actual)
- Primary completion
- 5 Oct 2016 (actual)
- Study completion
- 5 Oct 2016 (actual)
- First posted
- 12 Apr 2016 (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 is a Dental Pain Study which will evaluate the analgesic onset, efficacy and safety of 1000 mg acetaminophen as two Test acetaminophen 500 mg tablets, compared with commercial products of acetaminophen 1000 mg administered as two 500 mg caplets, and ibuprofen (IBU) 400 mg following third molar (wisdom tooth) extraction.
Detailed description
This is a single-dose, randomized, double-blind, triple-dummy, placebo- and active controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of Test acetaminophen 1000 mg compared with two commercial products over a six-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
| Arm | Type | Receives |
|---|---|---|
| Test acetaminophen | Experimental | Drug: acetaminophen Tablet, Drug: Placebo Caplet, Drug: Placebo Liquid-filled capsuleacetaminophen tablet and placebo caplet and placebo liquid-filled capsule |
| Commercial acetaminophen | Active comparator | Drug: acetaminophen Caplet, Drug: Placebo Tablet, Drug: Placebo Liquid-filled capsuleacetaminophen caplet and placebo tablet and placebo liquid-filled capsule |
| Commercial ibuprofen | Active comparator | Drug: ibuprofen Liquid-filled capsule, Drug: Placebo Tablet, Drug: Placebo Capletibuprofen liquid-filled capsule and placebo tablet and placebo caplet |
| Placebo | Placebo comparator | Drug: Placebo Tablet, Drug: Placebo Caplet, Drug: Placebo Liquid-filled capsulePlacebo tablet and placebo caplet and placebo liquid-filled capsule |
Who may qualify
- Ages
- 17 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 17 years to 50 years old
- Weight 100 lbs or greater with a body mass index (BMI) 18-30 inclusive
- Dental extraction of three or four molars
- Experience moderate to severe pain after extraction of third molars
- Females of childbearing age must be willing to use acceptable method of birth control
Key exclusion criteria (4 listed)
- Currently pregnant or planning to be pregnant or nursing a baby
- Known allergy to acetaminophen (ACM) or non-steroidal anti-inflammatory drugs (NSAIDS)
- Inability to swallow whole large tablets or capsules
- Have other conditions that the investigator feels may impact subject's safety and/or the integrity of the study
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 |
|---|---|---|
| acetaminophen TabletAlso: Test ACM2 test acetaminophen 500 mg tablets | Drug | Test acetaminophen |
| acetaminophen CapletAlso: Commercial ACM2 commercial acetaminophen 500 mg caplets | Drug | Commercial acetaminophen |
| ibuprofen Liquid-filled capsuleAlso: Commercial IBU2 commercial ibuprofen 200 mg Liquid-filled capsules | Drug | Commercial ibuprofen |
| Placebo Tablet2 placebo tablets | Drug | Commercial acetaminophen, Commercial ibuprofen, Placebo |
| Placebo Caplet2 placebo caplets | Drug | Commercial ibuprofen, Placebo, Test acetaminophen |
| Placebo Liquid-filled capsule2 placebo Liquid-filled capsules | Drug | Commercial acetaminophen, Placebo, Test acetaminophen |
Primary outcome
Time to first confirmed perceptible pain relief
Time frame: 6 hours
Minutes until confirmed first perceptible pain relief are achieved. Stopwatch is started after the subject takes the study medication. The subject is instructed to stop the stopwatch when they first begin to feel any pain relief. The first perceptible pain relief is confirmed if the subject also stopped the second stopwatch indicating meaningful pain relief.
6 secondary outcomes
Percentage of subjects with confirmed perceptible relief from 30 minutes to successively earlier minutes in one-minute increments (Test ACM versus placebo)
Time frame: 30 minutes or less
Risk ratios of confirmed perceptible relief by 10 minutes (Test acetominophen and commercial ibuprofen)
Time frame: 10 minutes or less
Risk ratios of confirmed perceptible relief by 15 minutes (Test acetominophen and commercial ibuprofen)
Time frame: 15 minutes or less
Risk ratios of confirmed perceptible relief by 20 minutes (Test acetominophen and commercial ibuprofen)
Time frame: 20 minutes or less
Percentage of subjects with meaningful relief by 30 minutes
Time frame: 30 minutes or less
Time to meaningful pain relief
Time frame: 6 hours
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 28 Sep 2022.
- Derived from this study: PubMed 38124555Myers A, Gelotte C, Zuckerman A, Zimmerman B, Shenoy A, Qi D, Cooper SA. Analgesic onset and efficacy of a fast-acting formulation of acetaminophen in a postoperative dental impaction pain model. Curr Med Res Opin. 2024 Feb;40(2):267-277. doi: 10.1080/03007995.2023.2294946. Epub 2024 Jan 24.
- Individual participant dataSharing planned: Yes. At this time we do plan to share IPD through the YODA site. The specific individual participant data sets have not yet been determined.
Related trials for Post Operative Dental Pain
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PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
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Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
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A Study of CYT-1010 in Healthy Volunteers and Participants With Acute Pain After Third Molar Extraction
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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.
Derek D. Muse, M.D. principal investigator
Jean Brown 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 acetaminophen Tablet, acetaminophen Caplet and ibuprofen Liquid-filled 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 5 inclusion and 4 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 28 Sep 2022. 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?
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?
Time to first confirmed perceptible pain relief (time frame: 6 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 NCT02735122, 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 28 Sep 2022.