PainPhase 2NCT04447040
Acetaminophen/Naproxen Sodium Dose Ranging Study
A Phase 2 study testing Acetaminophen/naproxen sodium Dose A, Acetaminophen/naproxen sodium Dose B and Acetaminophen/naproxen sodium Dose C in people with Pain, run by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division at 1 site in United States.
Trial summary
Study assessing the relative efficacy of five strengths of a fixed combination of acetaminophen and naproxen sodium is being investigated to help inform selection of dose(s) for further development and to evaluate the safety of a fixed combination of naproxen sodium and acetaminophen. Read more about this study
- Who is it for?
- Ages 17 to 50 years
- Conditions the study is for
- Pain
- What is being tested?
- Acetaminophen/naproxen sodium Dose A, Acetaminophen/naproxen sodium Dose B and Acetaminophen/naproxen sodium Dose C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 304 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2020to 3 May 2021
- Phase
- Phase 2
- 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
- Males or females 17-50 years old
- Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5-35.4 (inclusive) at screening
- Surgical removal of three or four third molars, of which, two must be mandibular impactions
- Meets requirements for post-surgical pain level
- 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 become 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, oxycodone or other opioids;
- Not able to swallow whole 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, or substance abuse, as judged by the investigator site staff, in the last 5 years
- Use of any immunosuppressive drugs within 2 weeks of screening
- History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Five Strengths of a Fixed Combination of Acetaminophen/Naproxen Sodium in Postoperative Dental Pain
Study assessing the relative efficacy of five strengths of a fixed combination of acetaminophen and naproxen sodium is being investigated to help inform selection of dose(s) for further development and to evaluate the safety of a fixed combination of naproxen sodium and acetaminophen.
Read the detailed description
This is a randomized, double-blind, placebo-controlled study to evaluate the analgesic efficacy and safety profile of the following doses of a fixed combination of Acetaminophen (APAP)/Naproxen sodium (NPX) administered as a single two-tablet dose:[Acetaminophen/Naproxen Sodium Dose A, Acetaminophen/Naproxen Sodium Dose B, Acetaminophen/Naproxen Sodium Dose C, Acetaminophen/Naproxen Sodium Dose D, Acetaminophen/Naproxen Sodium Dose E and Placebo] following surgical extraction of four third molars.
- Conditions
- Pain
- Being tested
- Acetaminophen/naproxen sodium Dose A, Acetaminophen/naproxen sodium Dose B, Acetaminophen/naproxen sodium Dose C, Acetaminophen/naproxen sodium Dose D, Acetaminophen/naproxen sodium Dose E
- Keywords
- Analgesics, Dental Pain, Acetaminophen, Naproxen Sodium, Pain, Fixed-Dose
- Medical subject headings
- Pain, Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen/naproxen sodium Dose ADrug
Acetaminophen/naproxen sodium Dose A administered as a single two-tablet dose.
Acetaminophen/naproxen sodium Dose BDrug
Acetaminophen/naproxen sodium Dose B administered as a single two-tablet dose.
Acetaminophen/naproxen sodium Dose CDrug
Acetaminophen/naproxen sodium Dose C administered as a single two-tablet dose.
Acetaminophen/naproxen sodium Dose DDrug
Acetaminophen/naproxen sodium Dose D administered as a single two-tablet dose.
Acetaminophen/naproxen sodium Dose EDrug
Acetaminophen/naproxen sodium Dose E administered as a single two-tablet dose.
PlaceboDrug
Placebo tablets administered as a single two-tablet dose.
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen/naproxen sodium Dose A | Experimental | Acetaminophen/naproxen sodium Dose A administered as a single two-tablet dose. Receives: Drug: Acetaminophen/naproxen sodium Dose A |
| Acetaminophen/naproxen sodium Dose B | Experimental | Acetaminophen/naproxen sodium Dose B administered as a single two-tablet dose. Receives: Drug: Acetaminophen/naproxen sodium Dose B |
| Acetaminophen/naproxen sodium Dose C | Experimental | Acetaminophen/naproxen sodium Dose C administered as a single two-tablet dose. Receives: Drug: Acetaminophen/naproxen sodium Dose C |
| Acetaminophen/naproxen sodium Dose D | Experimental | Acetaminophen/naproxen sodium Dose D administered as a single two-tablet dose. Receives: Drug: Acetaminophen/naproxen sodium Dose D |
| Acetaminophen/naproxen sodium Dose E | Experimental | Acetaminophen/naproxen sodium Dose E administered as a single two-tablet dose. Receives: Drug: Acetaminophen/naproxen sodium Dose E |
| Placebo | Placebo comparator | Placebo tablets administered as a single two-tablet dose. 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 Score From Baseline (0 Hour) to 12 Hours (SPID 0-12)
Time weighted sum of the pain intensity difference (SPID) score is derived from pain intensity difference (PID) score. Pain intensity-numerical rating scale (PI-NRS) was used to assess pain intensity on scale ranged from 0 (no pain) to 10 (very severe pain), higher score indicated severe pain intensity. PID score was the difference between baseline pain intensity and pain intensity at assessment timepoint (12 hours). The SPID scores were derived by first multiplying each PID score by the time from the previous time point and adding these time weighted PID scores together over the interval from 0 to 12 hours. The possible range of SPID for 0 to 12 hours was from -120 to 120. A higher value of SPID indicated greater pain relief.
Measured: Baseline (0 hour) up to 12 hours post-dose on Day 1
Secondary outcomes (4)
Time Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 12 Hours (TOTPAR 0-12)
Time weighted total pain relief (TOTPAR) was measured using a Pain Relief Numerical Rating Scale (PR-NRS) ranging from 0 to10 (0 = no relief, 10 = complete relief). A higher score indicated greater pain relief. Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value was 0, and the maximum value was 120. Higher scores were indicative of more pain relief.
Measured: Baseline (0 hour) up to 12 hours post-dose on Day 1
Time Weighted Sum of Pain Intensity Difference Score From 6 Hours to 12 Hours (SPID 6-12)
Time weighted sum of the pain intensity difference (SPID) score is derived from PID score. PI-NRS was used to assess pain intensity on scale ranged from 0 (no pain) to 10 (very severe pain), higher score indicated severe pain intensity. PID was the difference between pain intensity at 6 hours and pain intensity at assessment timepoint (12 hours). The SPID scores were derived by first multiplying each PID score by the time from the previous time point and adding these time weighted PID scores together over the intervals from 6 to 12 hours (6 hours). The possible range of SPID for 6 to12 hours was from -60 to 60. A higher value of SPID indicated greater pain relief.
Measured: From 6 hours up to 12 hours post-dose on Day 1
Time to First Use of Rescue Analgesic Medication
Time to first use of rescue analgesic medication was measured as the elapsed time (in minutes) from when the investigational product was given until the time rescue analgesic was first given. Participants who did not use rescue medication during the 24 hour study period had their time to rescue set to 24 hours and were censored at 24 hours. Kaplan-Meier method was used for the analysis.
Measured: From 0 minute up to 1440 minutes post-dose (that is, up to 24 hours post-dose) on Day 1
Proportion of Participants Who Required Rescue Analgesic Medication
Proportion (cumulative data) of participants who used rescue analgesic medication through 24 hours post study drug administration on Day 1 which was assessed by using Kaplan-Meier estimates were reported.
Measured: From 0 hour up to 24 hours post-dose on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start9 Nov 2020
- Primary completion9 Apr 2021
- Study completion3 May 2021
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 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
- Model description
- Post-operative dental pain following third molar extraction.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 304 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 Bertoch, MD, Principal investigator, JBR Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447040
- Sponsor's protocol ID
- CCSPAA002398
- Status last verified
- Mar 2024
- First submitted
- 23 Jun 2020
- Last updated
- 24 Mar 2025
- 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 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Five Strengths of a Fixed Combination of Acetaminophen/Naproxen Sodium in Postoperative Dental Pain
- ClinicalTrials.gov ID
- NCT04447040
- Acronym / sponsor ID
- CCSPAA002398
- Conditions
- Pain
- Keywords
- Analgesics, Dental Pain, Acetaminophen, Naproxen Sodium, Pain, Fixed-Dose
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 9 Apr 2021 (actual)
- Study completion
- 3 May 2021 (actual)
- First posted
- 25 Jun 2020 (actual)
- Results
- Posted 11 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study assessing the relative efficacy of five strengths of a fixed combination of acetaminophen and naproxen sodium is being investigated to help inform selection of dose(s) for further development and to evaluate the safety of a fixed combination of naproxen sodium and acetaminophen.
Detailed description
This is a randomized, double-blind, placebo-controlled study to evaluate the analgesic efficacy and safety profile of the following doses of a fixed combination of Acetaminophen (APAP)/Naproxen sodium (NPX) administered as a single two-tablet dose:[Acetaminophen/Naproxen Sodium Dose A, Acetaminophen/Naproxen Sodium Dose B, Acetaminophen/Naproxen Sodium Dose C, Acetaminophen/Naproxen Sodium Dose D, Acetaminophen/Naproxen Sodium Dose E and Placebo] following surgical extraction of 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
- 6
- Model description
- Post-operative dental pain following third molar extraction.
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen/naproxen sodium Dose A | Experimental | Drug: Acetaminophen/naproxen sodium Dose AAcetaminophen/naproxen sodium Dose A administered as a single two-tablet dose. |
| Acetaminophen/naproxen sodium Dose B | Experimental | Drug: Acetaminophen/naproxen sodium Dose BAcetaminophen/naproxen sodium Dose B administered as a single two-tablet dose. |
| Acetaminophen/naproxen sodium Dose C | Experimental | Drug: Acetaminophen/naproxen sodium Dose CAcetaminophen/naproxen sodium Dose C administered as a single two-tablet dose. |
| Acetaminophen/naproxen sodium Dose D | Experimental | Drug: Acetaminophen/naproxen sodium Dose DAcetaminophen/naproxen sodium Dose D administered as a single two-tablet dose. |
| Acetaminophen/naproxen sodium Dose E | Experimental | Drug: Acetaminophen/naproxen sodium Dose EAcetaminophen/naproxen sodium Dose E administered as a single two-tablet dose. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablets administered as a single two-tablet dose. |
Who may qualify
- Ages
- 17 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Males or females 17-50 years old
- Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5-35.4 (inclusive) at screening
- Surgical removal of three or four third molars, of which, two must be mandibular impactions
- Meets requirements for post-surgical pain level
- Females of childbearing potential and males agree to contraceptive requirements of study
Key exclusion criteria (8 listed)
- Pregnant female, breastfeeding, trying to become 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, oxycodone or other opioids;
- Not able to swallow whole 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 |
|---|---|---|
| Acetaminophen/naproxen sodium Dose AAcetaminophen/naproxen sodium Dose A administered as a single two-tablet dose. | Drug | Acetaminophen/naproxen sodium Dose A |
| Acetaminophen/naproxen sodium Dose BAcetaminophen/naproxen sodium Dose B administered as a single two-tablet dose. | Drug | Acetaminophen/naproxen sodium Dose B |
| Acetaminophen/naproxen sodium Dose CAcetaminophen/naproxen sodium Dose C administered as a single two-tablet dose. | Drug | Acetaminophen/naproxen sodium Dose C |
| Acetaminophen/naproxen sodium Dose DAcetaminophen/naproxen sodium Dose D administered as a single two-tablet dose. | Drug | Acetaminophen/naproxen sodium Dose D |
| Acetaminophen/naproxen sodium Dose EAcetaminophen/naproxen sodium Dose E administered as a single two-tablet dose. | Drug | Acetaminophen/naproxen sodium Dose E |
| PlaceboPlacebo tablets administered as a single two-tablet dose. | Drug | Placebo |
Primary outcome
Time Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 12 Hours (SPID 0-12)
Time frame: Baseline (0 hour) up to 12 hours post-dose on Day 1
Time weighted sum of the pain intensity difference (SPID) score is derived from pain intensity difference (PID) score. Pain intensity-numerical rating scale (PI-NRS) was used to assess pain intensity on scale ranged from 0 (no pain) to 10 (very severe pain), higher score indicated severe pain intensity. PID score was the difference between baseline pain intensity and pain intensity at assessment timepoint (12 hours). The SPID scores were derived by first multiplying each PID score by the time from the previous time point and adding these time weighted PID scores together over the interval from 0 to 12 hours. The possible range of SPID for 0 to 12 hours was from -120 to 120. A higher value of SPID indicated greater pain relief.
4 secondary outcomes
Time Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 12 Hours (TOTPAR 0-12)
Time frame: Baseline (0 hour) up to 12 hours post-dose on Day 1
Time Weighted Sum of Pain Intensity Difference Score From 6 Hours to 12 Hours (SPID 6-12)
Time frame: From 6 hours up to 12 hours post-dose on Day 1
Time to First Use of Rescue Analgesic Medication
Time frame: From 0 minute up to 1440 minutes post-dose (that is, up to 24 hours post-dose) on Day 1
Proportion of Participants Who Required Rescue Analgesic Medication
Time frame: From 0 hour up to 24 hours post-dose on Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- 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.
Related trials for Pain
Not yet recruiting
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
Not yet recruitingPhase 3
Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT
Chronic Low Back Pain, Musculoskeletal Pain
Not yet recruiting
Testing the Timing and Application of Virtual Reality Distraction During Knee Injections in a VA Pain Clinic
Pain Management, Injection Pain Prevention
Not yet recruiting
The Effect of a Ginger Formula on Menstrual Health vs a Placebo
Painful Menstruation
Not yet recruitingEarly Phase 1
Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
Opioid Use Disorder, Alcohol Intoxication
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 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 2 study testing Acetaminophen/naproxen sodium Dose A, Acetaminophen/naproxen sodium Dose B and Acetaminophen/naproxen sodium Dose C in people with 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 24 Mar 2025. 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?
Yes. Results are posted in the registry (first posted 11 Apr 2024). 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 Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 12 Hours (SPID 0-12) (time frame: Baseline (0 hour) up to 12 hours post-dose on Day 1). 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 24 Mar 2025.