Dental PainPhase 2NCT02320708
Study of Acetaminophen (ACE) in Post-operative Dental Pain
A Phase 2 study testing Acetaminophen (ACE) (1000 mg), Commercial ACE (1000 mg) and Commercial Ibuprofen (IBU) (400 mg) in people with Dental Pain, run by Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. at 1 site in United States.
Trial summary
This is a dental pain study evaluating the efficacy and safety of a single dose of test acetaminophen (ACE) (1000 mg) compared to commercial acetaminophen (1000 mg), ibuprofen (IBU) (400 mg), and placebo over a 6 hour period. Subjects will undergo dental extraction of three or four third molars. Read more about this study
- Who is it for?
- Ages 17 to 50 years
- Conditions the study is for
- Dental Pain
- What is being tested?
- Acetaminophen (ACE) (1000 mg), Commercial ACE (1000 mg) and Commercial Ibuprofen (IBU) (400 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2014to 30 Apr 2015
- Phase
- Phase 2
- 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
- Are 17 to 50 years of age
- Weigh 100 lbs or greater and body mass index (BMI) 18 to 30 (inclusive)
- Dental extraction of three or four third-molars.
- Experience moderate to severe pain after extraction of third molars
Who cannot join
- Currently pregnant (or planning to be pregnant) or nursing a baby
- Known allergy to acetaminophen (ACE) 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 Proof of Concept Study of a Test Acetaminophen 500 mg Tablet in Postoperative Dental Pain
This is a dental pain study evaluating the efficacy and safety of a single dose of test acetaminophen (ACE) (1000 mg) compared to commercial acetaminophen (1000 mg), ibuprofen (IBU) (400 mg), and placebo over a 6 hour period. Subjects will undergo dental extraction of three or four third molars.
- Conditions
- Dental Pain
- Being tested
- Acetaminophen (ACE) (1000 mg), Commercial ACE (1000 mg), Commercial Ibuprofen (IBU) (400 mg), Placebo
- Keywords
- Molar,third; Teeth,wisdom; Pain, Postoperative; Dental Surgery; Third molar extraction
- Medical subject headings
- Toothache, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen (ACE) (1000 mg)Drug
2 Test ACE 500 mg tablets taken orally one time
Commercial ACE (1000 mg)Drug
2 ACE 500 mg caplets taken orally one time
Commercial Ibuprofen (IBU) (400 mg)Drug
2 IBU 200 mg soft-gels taken orally one time
PlaceboDrug
2 placebo caplets for acetaminophen taken orally one time
PlaceboDrug
2 placebo soft-gels for ibuprofen taken orally one time
PlaceboDrug
2 placebo tablets for Test acetaminophen taken orally one time
| Study group | Role | What they receive |
|---|---|---|
| Test Acetaminophen (ACE) (1000 mg) and placebo | Experimental | Not described Receives: Drug: Acetaminophen (ACE) (1000 mg); Drug: Placebo |
| Commerical ACE (1000 mg) and placebo | Active comparator | Not described Receives: Drug: Commercial ACE (1000 mg); Drug: Placebo |
| Commerical Ibuprofen (IBU) (400 mg) and placebo | Active comparator | Not described Receives: Drug: Commercial Ibuprofen (IBU) (400 mg); Drug: Placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time weighted sum of pain intensity difference from 0-6 hours (SPID 0-6)
Time weighted sum of pain intensity difference scores from baseline over 6 hours. Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Measured: 6 Hours
Secondary outcomes (31)
Time weighted sum of pain intensity difference from 0-4 hours (SPID 0-4)
Time weighted sum of pain intensity difference scores from baseline over 4 hours. Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Measured: 4 Hours
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: Within 6 Hours
Time to first perceptible pain relief
Minutes until first perceptible pain relief is 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.
Measured: Within 6 Hours
Time to confirmed first perceptible 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: Within 6 Hours
Time weighted sum of pain relief from 0-4 (TOTPAR 0-4)
Time weighted sum of pain relief scores over four hours. Pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Measured: 4 hours
Time weighted sum of pain relief from 0-6 (TOTPAR 0-6)
Time weighted sum of pain relief scores over six hours. Pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Measured: 6 hours
Duration of relief after dosing (time to rescue analgesic)
Minutes until rescue medication is given
Measured: 6 Hours
Proportion of subjects taking a rescue analgesic by 6 hours
Percentage of subjects using rescue medication through six hours
Measured: 6 Hours
Subject Global Evaluation assessed at hour 6 or at time of rescue
Patient assessment of the pain medication - number of subjects rating the medication they received as a pain reliever on a score of 0-4, where 0=poor, 1=fair, 2=good, 3=very good, 4=excellent
Measured: 6 hours
Pain relief (PAR) scores at 0.25 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Measured: 0.25 Hours
Pain relief (PAR) scores at 0.5 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Measured: 0.5 Hours
Pain relief (PAR) scores at 0.75 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Measured: 0.75 Hours
Pain relief (PAR) scores at 1 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Measured: 1 Hours
Pain relief (PAR) scores at 1.25 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Measured: 1.25 Hours
Pain relief (PAR) scores at 1.5 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Measured: 1.5 Hours
Pain relief (PAR) scores at 2 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Measured: 2 hoursH
Pain relief (PAR) scores at 3 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Measured: 3 Hours
Pain relief (PAR) scores at 4 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Measured: 4 Hours
Pain relief (PAR) scores at 5 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Measured: 5 Hours
Pain relief (PAR) scores at 6 Hours
Pain relief scores at each assessment time point - pain relief was evaluated using a 0-10 pain relief numerical rating scale (PR-NRS) where 0 = no relief and 10 = complete relief
Measured: 6 Hours
Pain intensity difference (PID) at 0.25 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Measured: 0.25 Hours
Pain intensity difference (PID) at 0.5 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Measured: 0.5 Hours
Pain intensity difference (PID) at 0.75 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Measured: 0.75 Hours
Pain intensity difference (PID) at 1 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Measured: 1 Hours
Pain intensity difference (PID) at 1.25 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Measured: 1.25 Hours
Pain intensity difference (PID) at 1.5 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Measured: 1.5 Hours
Pain intensity difference (PID) at 2 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Measured: 2 Hours
Pain intensity difference (PID) at 3 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Measured: 3 Hours
Pain intensity difference (PID) at 4 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Measured: 4 Hours
Pain intensity difference (PID) at 5 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
Measured: 5 Hours
Pain intensity difference (PID) at 6 Hours
Pain intensity difference (PID) from baseline at each assessment time point - Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
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 posted19 Dec 2014 (estimated)
- Study start31 Dec 2014
- Primary completion30 Apr 2015
- Study completion30 Apr 2015
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Consumer and Personal Products Worldwide
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320708
- Sponsor's protocol ID
- CO-140128120904-PACT
- Status last verified
- Nov 2021
- First submitted
- 16 Dec 2014
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. 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 Proof of Concept Study of a Test Acetaminophen 500 mg Tablet in Postoperative Dental Pain
- ClinicalTrials.gov ID
- NCT02320708
- Acronym / sponsor ID
- CO-140128120904-PACT
- Conditions
- Dental Pain
- Keywords
- Molar,third; Teeth,wisdom; Pain, Postoperative; Dental Surgery; Third molar extraction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Consumer and Personal Products Worldwide
- Study start
- 31 Dec 2014 (actual)
- Primary completion
- 30 Apr 2015 (actual)
- Study completion
- 30 Apr 2015 (actual)
- First posted
- 19 Dec 2014 (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 evaluating the efficacy and safety of a single dose of test acetaminophen (ACE) (1000 mg) compared to commercial acetaminophen (1000 mg), ibuprofen (IBU) (400 mg), and placebo over a 6 hour period. 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 (ACE) (1000 mg) and placebo | Experimental | Drug: Acetaminophen (ACE) (1000 mg), Drug: Placebo |
| Commerical ACE (1000 mg) and placebo | Active comparator | Drug: Commercial ACE (1000 mg), Drug: Placebo |
| Commerical Ibuprofen (IBU) (400 mg) and placebo | Active comparator | Drug: Commercial Ibuprofen (IBU) (400 mg), Drug: Placebo |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 17 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Are 17 to 50 years of age
- Weigh 100 lbs or greater and body mass index (BMI) 18 to 30 (inclusive)
- Dental extraction of three or four third-molars.
- Experience moderate to severe pain after extraction of third molars
Key exclusion criteria (4 listed)
- Currently pregnant (or planning to be pregnant) or nursing a baby
- Known allergy to acetaminophen (ACE) 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 (ACE) (1000 mg)2 Test ACE 500 mg tablets taken orally one time | Drug | Test Acetaminophen (ACE) (1000 mg) and placebo |
| Commercial ACE (1000 mg)2 ACE 500 mg caplets taken orally one time | Drug | Commerical ACE (1000 mg) and placebo |
| Commercial Ibuprofen (IBU) (400 mg)2 IBU 200 mg soft-gels taken orally one time | Drug | Commerical Ibuprofen (IBU) (400 mg) and placebo |
| Placebo2 placebo caplets for acetaminophen taken orally one time | Drug | Commerical Ibuprofen (IBU) (400 mg) and placebo, Placebo, Test Acetaminophen (ACE) (1000 mg) and placebo |
| Placebo2 placebo soft-gels for ibuprofen taken orally one time | Drug | Commerical ACE (1000 mg) and placebo, Placebo, Test Acetaminophen (ACE) (1000 mg) and placebo |
| Placebo2 placebo tablets for Test acetaminophen taken orally one time | Drug | Commerical ACE (1000 mg) and placebo, Commerical Ibuprofen (IBU) (400 mg) and placebo, Placebo |
Primary outcome
Time weighted sum of pain intensity difference from 0-6 hours (SPID 0-6)
Time frame: 6 Hours
Time weighted sum of pain intensity difference scores from baseline over 6 hours. Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
31 secondary outcomes
Time weighted sum of pain intensity difference from 0-4 hours (SPID 0-4)
Time frame: 4 Hours
Time to meaningful pain relief
Time frame: Within 6 Hours
Time to first perceptible pain relief
Time frame: Within 6 Hours
Time to confirmed first perceptible relief
Time frame: Within 6 Hours
Time weighted sum of pain relief from 0-4 (TOTPAR 0-4)
Time frame: 4 hours
Time weighted sum of pain relief from 0-6 (TOTPAR 0-6)
Time frame: 6 hours
Duration of relief after dosing (time to rescue analgesic)
Time frame: 6 Hours
Proportion of subjects taking a rescue analgesic by 6 hours
Time frame: 6 Hours
Subject Global Evaluation assessed at hour 6 or at time of rescue
Time frame: 6 hours
Pain relief (PAR) scores at 0.25 Hours
Time frame: 0.25 Hours
Pain relief (PAR) scores at 0.5 Hours
Time frame: 0.5 Hours
Pain relief (PAR) scores at 0.75 Hours
Time frame: 0.75 Hours
Pain relief (PAR) scores at 1 Hours
Time frame: 1 Hours
Pain relief (PAR) scores at 1.25 Hours
Time frame: 1.25 Hours
Pain relief (PAR) scores at 1.5 Hours
Time frame: 1.5 Hours
Pain relief (PAR) scores at 2 Hours
Time frame: 2 hoursH
Pain relief (PAR) scores at 3 Hours
Time frame: 3 Hours
Pain relief (PAR) scores at 4 Hours
Time frame: 4 Hours
Pain relief (PAR) scores at 5 Hours
Time frame: 5 Hours
Pain relief (PAR) scores at 6 Hours
Time frame: 6 Hours
Pain intensity difference (PID) at 0.25 Hours
Time frame: 0.25 Hours
Pain intensity difference (PID) at 0.5 Hours
Time frame: 0.5 Hours
Pain intensity difference (PID) at 0.75 Hours
Time frame: 0.75 Hours
Pain intensity difference (PID) at 1 Hours
Time frame: 1 Hours
Pain intensity difference (PID) at 1.25 Hours
Time frame: 1.25 Hours
Pain intensity difference (PID) at 1.5 Hours
Time frame: 1.5 Hours
Pain intensity difference (PID) at 2 Hours
Time frame: 2 Hours
Pain intensity difference (PID) at 3 Hours
Time frame: 3 Hours
Pain intensity difference (PID) at 4 Hours
Time frame: 4 Hours
Pain intensity difference (PID) at 5 Hours
Time frame: 5 Hours
Pain intensity difference (PID) at 6 Hours
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 3 Dec 2021.
- Individual participant dataSharing planned: Undecided
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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.
Study Director study director
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acetaminophen (ACE) (1000 mg), Commercial ACE (1000 mg) and Commercial Ibuprofen (IBU) (400 mg) in people with Dental Pain, run by Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. 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 4 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 3 Dec 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 weighted sum of pain intensity difference from 0-6 hours (SPID 0-6) (time frame: 6 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 3 Dec 2021.