A Phase 3 interventional study of Acetaminophen/Naproxen Sodium Fixed Combination and Naproxen Sodium in Pain, sponsored by Johnson & Johnson Consumer Inc. (J&JCI). Completed at 1 site in United States. Open to participants aged 16 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Johnson & Johnson Consumer Inc. (J&JCI) (formerly part of Johnson & Johnson) · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate how well a fixed combination of acetaminophen/naproxen sodium relieves postoperative dental pain compared with acetaminophen, naproxen sodium and placebo.
This is a randomized, double-blind, placebo-controlled, single-dose full-factorial study to evaluate the analgesic efficacy and safety of a fixed combination of acetaminophen and naproxen sodium, compared with acetaminophen or naproxen sodium alone, and placebo following surgical extraction of three or four third molars.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's enrollment of 447 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Johnson & Johnson Consumer Inc. (J&JCI) is the lead sponsor of 55 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 10 (83%) have results posted.
First submitted before Johnson & Johnson Consumer Inc. (J&JCI) left Johnson & Johnson.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a single oral dose of two Acetaminophen/Naproxen Sodium Fixed Combination tablets.
Drug: Acetaminophen/Naproxen Sodium Fixed Combination
Participants will receive a single oral dose of one Naproxen Sodium tablet with one Placebo capsule.
Drug: Naproxen Sodium · Drug: Placebo
Participants will receive a single oral dose of two Acetaminophen tablets.
Drug: Acetaminophen
Participants will receive a single oral dose of two Placebo capsules.
Drug: Placebo
Fixed combination of Acetaminophen/Naproxen Sodium will be administered orally.
Naproxen Sodium will be administered orally.
Acetaminophen will be administered orally.
Placebo will be administered orally.
Time-weighted Sum of Pain Intensity Difference From 0 to 12 Hours After Dosing (SPID 0-12)
Time-weighted sum of the pain intensity difference (SPID) scores were calculated using a Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain) collected at each scheduled timepoint within the specified timeframe. The Pain Intensity Difference (PID) at each time point was derived by subtracting the pain intensity at that time point from the baseline pain intensity. The SPID scores were derived by first multiplying each PID score by the time from the previous timepoint and adding these time weighted PID scores together over the intervals from 0-12 hours. PID is ranging from 0 to 10 point and SPID 0-12 ranging from 0 to 120. A higher value of SPID indicated greater pain relief.
Time frame: Baseline (0 hour) up to 12 hours post-dose
Time-weighted Sum of Pain Intensity Difference From 6 to 12 Hours (SPID 6-12)
Time-weighted sum of the pain intensity difference (SPID) scores were calculated using a Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain) collected at each scheduled timepoint within the specified timeframe. The Pain Intensity Difference (PID) at each time point was derived by subtracting the pain intensity at that time point from the baseline pain intensity. The SPID scores were derived by first multiplying each PID score by the time from the previous timepoint and adding these time weighted PID scores together over the intervals from 6-12 hours. PID is ranging from 0 to 10 point and SPID6-12 ranging from 0 to 60. A higher value of SPID indicated greater pain relief.
Time frame: From 6 to 12 hours
Time to First Request of Rescue Analgesic
Time to first request for rescue medication was measured as the elapsed time from when investigational product (IP) was given until the time rescue medication was first requested.
Time frame: 0 to 24 hours
Proportion of Subjects Who Request Rescue Analgesic During the First 12 Hours
Proportion of participants who requested rescue analgesic during the first 12 hours was reported.
Time frame: Up to 12 hours
| Milestone | Acetaminophen/Naproxen Sodium Fixed Combination | Naproxen Sodium | Acetaminophen | Placebo |
|---|---|---|---|---|
| Started | 160 | 162 | 82 | 43 |
| Completed | 159 | 161 | 81 | 43 |
| Not completed | 1 | 1 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 1 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 | 0 |
Time-weighted sum of the pain intensity difference (SPID) scores were calculated using a Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain) collected at each scheduled timepoint within the specified timeframe. The Pain Intensity Difference (PID) at each time point was derived by subtracting the pain intensity at that time point from the baseline pain intensity. The SPID scores were derived by first multiplying each PID score by the time from the previous timepoint and adding these time weighted PID scores together over the intervals from 0-12 hours. PID is ranging from 0 to 10 point and SPID 0-12 ranging from 0 to 120. A higher value of SPID indicated greater pain relief.
| units on a scale*hours | Acetaminophen/Naproxen Sodium Fixed Combination | Naproxen Sodium | Acetaminophen | Placebo |
|---|---|---|---|---|
| Time-weighted Sum of Pain Intensity Difference From 0 to 12 Hours After Dosing (SPID 0-12) | 49.33 ± 2.090 | 40.74 ± 2.075 | 24.01 ± 2.912 | 4.11 ± 4.002 |
Time-weighted sum of the pain intensity difference (SPID) scores were calculated using a Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain) collected at each scheduled timepoint within the specified timeframe. The Pain Intensity Difference (PID) at each time point was derived by subtracting the pain intensity at that time point from the baseline pain intensity. The SPID scores were derived by first multiplying each PID score by the time from the previous timepoint and adding these time weighted PID scores together over the intervals from 6-12 hours. PID is ranging from 0 to 10 point and SPID6-12 ranging from 0 to 60. A higher value of SPID indicated greater pain relief.
| units on a scale*hours | Acetaminophen/Naproxen Sodium Fixed Combination | Naproxen Sodium | Acetaminophen | Placebo |
|---|---|---|---|---|
| Time-weighted Sum of Pain Intensity Difference From 6 to 12 Hours (SPID 6-12) | 22.24 ± 1.166 | 20.46 ± 1.158 | 8.39 ± 1.624 | 2.32 ± 2.233 |
Time to first request for rescue medication was measured as the elapsed time from when investigational product (IP) was given until the time rescue medication was first requested.
| Minutes | Acetaminophen/Naproxen Sodium Fixed Combination | Naproxen Sodium | Acetaminophen | Placebo |
|---|---|---|---|---|
| Time to First Request of Rescue Analgesic | 762.0 (687.0 to NA) | NA (716.0 to NA) | 382.0 (320.0 to 482.0) | 88.0 (81.0 to 95.0) |
Proportion of participants who requested rescue analgesic during the first 12 hours was reported.
| Percent of participants | Acetaminophen/Naproxen Sodium Fixed Combination | Naproxen Sodium | Acetaminophen | Placebo |
|---|---|---|---|---|
| Proportion of Subjects Who Request Rescue Analgesic During the First 12 Hours | 46.3 | 43.8 | 79.3 | 86.0 |
Collected over Adverse events were collected starting from the time a subject signed and dated the informed consent and until the completion of the subject's last study-related procedure, including contact for follow-up of safety, up to Day 10.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acetaminophen/Naproxen Sodium Fixed Combination | 0/160 (0%) | 0/160 (0%) | 8/160 (5%) |
| Naproxen Sodium | 0/162 (0%) | 0/162 (0%) | 8/162 (4.9%) |
| Acetaminophen | 0/82 (0%) | 0/82 (0%) | 5/82 (6.1%) |
| Placebo | 0/43 (0%) | 0/43 (0%) | 7/43 (16.3%) |
| Event | Acetaminophen/Naproxen Sodium Fixed Combination | Naproxen Sodium | Acetaminophen | Placebo |
|---|---|---|---|---|
| VomitingGastrointestinal disorders | 2/160 | 1/162 | 0/82 | 2/43 |
| HeadacheNervous system disorders | 0/160 | 2/162 | 1/82 | 2/43 |
| NauseaGastrointestinal disorders | 2/160 | 4/162 | 2/82 | 1/43 |
| DizzinessNervous system disorders | 1/160 | 0/162 | 0/82 | 1/43 |
| HypoaesthesiaNervous system disorders | 0/160 | 0/162 | 0/82 | 1/43 |
| Postoperative thrombosisInjury, poisoning and procedural complications | 1/160 | 0/162 | 1/82 | 1/43 |
| Incision site haemorrhageInjury, poisoning and procedural complications | 0/160 | 0/162 | 0/82 | 1/43 |
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 0/160 | 0/162 | 1/82 | 0/43 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 0/160 | 0/162 | 1/82 | 0/43 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 0/160 | 0/162 | 1/82 | 0/43 |
| Age, Continuous(years) | Acetaminophen/Naproxen Sodium Fixed Combination | Naproxen Sodium | Acetaminophen | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 17.9 ± 1.84 | 17.8 ± 1.89 | 18.0 ± 1.68 | 17.6 ± 1.68 | 17.8 ± 1.81 |
| Age, Customized(Participants) | Acetaminophen/Naproxen Sodium Fixed Combination | Naproxen Sodium | Acetaminophen | Placebo | Total |
|---|---|---|---|---|---|
| <18 years | 83 | 88 | 35 | 25 | 231 |
| ≥18 years | 77 | 74 | 47 | 18 | 216 |
| Sex: Female, Male(Participants) | Acetaminophen/Naproxen Sodium Fixed Combination | Naproxen Sodium | Acetaminophen | Placebo | Total |
|---|---|---|---|---|---|
| Female | 65 | 65 | 33 | 15 | 178 |
| Male | 95 | 97 | 49 | 28 | 269 |
| Ethnicity (NIH/OMB)(Participants) | Acetaminophen/Naproxen Sodium Fixed Combination | Naproxen Sodium | Acetaminophen | Placebo | Total |
|---|---|---|---|---|---|
| Ethnicity (NIH/OMB) — Hispanic or Latino | 23 | 23 | 11 | 4 | 61 |
| Ethnicity (NIH/OMB) — Not Hispanic or Latino | 135 | 137 | 71 | 39 | 382 |
| Ethnicity (NIH/OMB) — Unknown or Not Reported | 2 | 2 | 0 | 0 | 4 |
| Race (NIH/OMB)(Participants) | Acetaminophen/Naproxen Sodium Fixed Combination | Naproxen Sodium | Acetaminophen | Placebo | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 0 | 0 | 2 |
| Asian | 0 | 3 | 1 | 0 | 4 |
| Native Hawaiian or Other Pacific Islander | 3 | 2 | 2 | 0 | 7 |
| Black or African American | 1 | 1 | 0 | 1 | 3 |
| White | 151 | 152 | 77 | 42 | 422 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 3 | 2 | 0 | 9 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Data sharing details ↗ · yoda.yale.edu
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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