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PainPhase 3NCT05868122

A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy

A Phase 3 study testing Acetaminophen/Naproxen Sodium Fixed Combination in people with Pain, run by Johnson & Johnson Consumer Inc. (J&JCI) at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate effectiveness of a fixed combination of acetaminophen/naproxen sodium compared with placebo for reduction of pain when administered as multiple doses over a 48-hour period. Read more about this study

Who is it for?
Ages 16 to 65 years
Conditions the study is for
Pain
What is being tested?
Acetaminophen/Naproxen Sodium Fixed Combination
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
143 participants
Where
4 sitesUnited States
Study dates
7 Sep 2023to 30 May 2024
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 16 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Females have a negative urine pregnancy at screening and on the morning of surgery
  • Weight of 100 pounds or greater and have a body mass index (BMI) of 17.5 to 38.0 (inclusive) at screening
  • Scheduled to undergo primary, unilateral, distal, first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures. Participants who have previously undergone bunionectomy on the contralateral foot will not be prohibited from enrolling in this study if performed greater than or equal to (>=) 6 months
  • Are able to comprehend and follow the requirements of the study (including pre-surgical instructions provided by the site and availability on scheduled visit dates) based upon research site personnel's assessment
  • Provide written informed consent (for participants who are below the age of legal consent, parent or legally authorized representative provides written informed consent and the participant provides written assent)
  • Participant agrees to the contraceptive requirements
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  • Are willing for this to be the only investigational product used during the study
  • Have a negative urine drug screen at screening, and on day of surgical procedure. a) a positive drug screen for a known prescribed concomitant medication that is not otherwise exclusionary will not disqualify a participant; b) drug and alcohol screen results must be negative for a participant to receive study medication, a positive Tetrahydrocannabinol (THC) screen will only be exclusionary on day of surgery (Day 0)
  • Postoperative Inclusion Criteria
  • Participant reports both of the following after discontinuation of the popliteal block and before 2:00 PM on Day 1. a) moderate or severe pain on a 4-point categorical pain rating scale (with categories of none, mild, moderate, or severe; b) a score >= 5 on 11-point pain intensity-numerical pain rating scale (PI-NRS)
  • Participant is able to answer questions and follow commands, and appropriately participate in requisite pain evaluation assessments dictated in the protocol
  • The surgical procedure from incision to closure was not longer than 2 hours
  • The participant has had no evidence of respiratory insufficiency, clinically significant hypotension, brady cardia, or any other abnormality, during or following surgery that, in the Investigator's opinion, significantly increases the risks of study drug administration
  • There were no significant deviations from the surgical protocol, anesthetic protocol, or specified analgesic regimen, that would, in the opinion of the Investigator, put the participant at risk of participation in the trial, confound the analgesic endpoints of the trial or cause concern regarding the participants ability to participate in the trial

Who cannot join

  • Are female and are pregnant, breastfeeding, or currently trying to become pregnant
  • Are male with a pregnant partner or a partner who is currently trying to become pregnant
  • Have a known allergy or hypersensitivity to: a) naproxen or other nonsteroidal anti-inflammatory drugs, including aspirin; b) oxycodone or other opioids; c) acetaminophen; d) any other drug listed in the surgical and anesthetic protocol or postoperative pain management of the study protocol
  • Have presence or a history of major medical condition that in the investigator's opinion may jeopardize the participant's safety or well-being, or the integrity of the study, example; a) hepatic, renal, pancreatic, gastrointestinal, cardiovascular, cerebrovascular, or thyroid diseases; b) history of head injury or seizures; c) history of respiratory depression or lung problems such as but not limited to asthma or chronic obstructive pulmonary disease; d) psychiatric disorders (although participants with well-controlled depression or anxiety, who are on a stable dose of medication may be allowed); e) problems urinating; f) history of blockage or narrowing of the stomach or intestines; g) uncontrolled hypertension indicated as systolic blood pressure >=160 millimetres of mercury (mmHg) or diastolic blood pressure >=100 mmHg. Blood pressure may be repeated after the participant has remained in a rested state for at least 10 minutes. The final blood pressure value will be used for eligibility; h) uncontrolled diabetes, as determined by the investigator, in the last six months; i) medical conditions that would interfere with normal pain perception (example diabetic neuropathy) in the opinion of the Investigator
  • Have a history of endoscopically documented peptic ulcer disease or bleeding disorder in the last two years
  • Are not able to swallow whole large tablets or capsules
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  • Participants will be excluded from the study for any of the following:a) routine use of oral analgesics >=3 times per week for a medical condition unrelated to bunion pain in the 2 months prior to surgery; b) opioid tolerant, that is, the participant is currently taking or has taken a chronic opioid for pain at a dose greater than or equal to 10 milligrams (mg) hydrocodone per day, more than 1 out of 7 days per week, in the 2 months prior to surgery; c. History of chronic tranquilizer use, heavy drinking, opioid abuse, or other substance abuse, as judged by the Investigator, in the last five years. Heavy drinking is defined as the use of more than four standard drinks daily or more than 14 drinks a week for men, and more than three standard drinks daily or more than seven standard drinks in a week for women. Standard drink refers to 14 grams (g) (0.6 ounce [oz.]) of pure alcohol, which is approximately 12 oz. of beer, 8 oz. of malt liquor, 5 oz. of wine, 1.5 oz. or "shot" of 80 proof distilled spirits or liquor (example., gin, rum, vodka, or whiskey); d) use of any immunosuppressive drugs, corticosteroids (except for topical corticosteroids), or injectable or oral anticoagulants (example., heparin, Lovenox, Xarelto, Eliquis, Pradaxa, Coumadin, Miradon) within 2 weeks prior to surgery; e) use of monoamine oxidase inhibitors within 2 weeks prior to surgery; f) use of alcohol within 24 hours prior to surgery; g) consumption of methylxanthine containing products (example, chocolate bars or chocolate beverages, coffee, tea, cola or caffeinated energy drinks), tobacco, or nicotine containing products (example, cigarettes, cigars, nicotine replacement therapies, vaping devices) less than (<) 12 hours prior to surgery; h) use of any other over-the-counter or prescription medications or supplements that, in the Investigator's opinion, may cause participation in the study to jeopardize the participant's safety or well-being, or may jeopardize the integrity of the study, within 5 days (or longer if the investigator deems a longer washout is warranted) prior to surgery
  • Have a positive test for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV)
  • Have participated in any interventional clinical trials within 30 days before screening
  • Are related to those persons involved directly or indirectly with the conduct of this study (that is., Principal Investigator, sub-investigators, study coordinators, other site personnel, employees of Johnson \& Johnson [J\&J] subsidiaries, contractors of J\&J, and the families of each)

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • First Surgical Hospital

    Bellaire, Texas, 77401

  • The Heights Hospital / Memorial Herman Village

    Houston, Texas, 77008

  • Lotus Clinical Research, LLC

    New Providence, New Jersey, 07974

  • Endeavor Clinical Trails

    San Antonio, Texas, 78240

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Multidose Clinical Trial to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy

The purpose of this study is to evaluate effectiveness of a fixed combination of acetaminophen/naproxen sodium compared with placebo for reduction of pain when administered as multiple doses over a 48-hour period.

Conditions
Pain
Being tested
Acetaminophen/Naproxen Sodium Fixed Combination, Placebo
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acetaminophen/Naproxen Sodium Fixed CombinationDrug

    Fixed combination of Acetaminophen/Naproxen Sodium will be administered orally.

  • PlaceboDrug

    Placebo will be administered orally.

Study groups in NCT05868122
Study groupRoleWhat they receive
Acetaminophen/Naproxen Sodium Fixed CombinationExperimentalParticipants will receive oral doses of two Acetaminophen/Naproxen Sodium Fixed Combination tablets taken with water. Multiple doses will be administered over a 48-hour period.
Receives: Drug: Acetaminophen/Naproxen Sodium Fixed Combination
PlaceboPlacebo comparatorParticipants will receive oral doses of two placebo tablets taken with water. Multiple doses will be administered over a 48-hour period.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time-weighted Sum of Pain Intensity Difference Score From 0 to 24 Hours After Dosing (SPID 0-24)

    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 0-24 hours. PID is ranging from 0 to 10 point and SPID0-24 ranging from 0 to 240. A higher value of SPID indicated greater pain relief.

    Measured: Baseline (0 hour) up to 24 hours post-dose

Secondary outcomes (6)

  1. Time-weighted SPID Score 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 SPID0-12 ranging from 0 to120. A higher value of SPID indicated greater pain relief.

    Measured: Baseline (0 hour) up to 12 hours post-dose

  2. Time-weighted SPID From 0 to 48 Hours After Dosing (SPID 0-48)

    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 0-48 hours. PID is ranging from 0 to 10 point and SPID0-48 ranging from 0 to 480. A higher value of SPID indicated greater pain relief.

    Measured: Baseline (0 hour) up to 48 hours post-dose

  3. Time to Confirmed Perceptible Pain Relief (TCPR)

    TCPR is defined as the time (in minutes) to perceptible pain relief as indicated on the first stopwatch, provided that the participant also stopped the second stopwatch indicating meaningful pain relief.

    Measured: Up to 12 hours

  4. Time to Meaningful Pain Relief (TMPR)

    TMPR is defined as the time (in minutes) to meaningful pain relief as indicated on the second stopwatch.

    Measured: Up to 12 hours

  5. Time to First Use of Rescue Medication

    Time to first use of rescue medication was measured as the elapsed time from when investigational product was given until the time rescue medication was first given.

    Measured: Up to 48 hours

  6. Proportion of Participants Who Use Rescue Medication During the First 12 Hours

    Proportion of participants who use rescue medication during the first 12 hours was reported.

    Measured: Up to 12 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2023
  2. Study start7 Sep 2023
  3. Primary completion25 May 2024
  4. Study completion30 May 2024

Resources

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
143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05868122
Sponsor's protocol ID
CCSPAA005197
Other IDs
CCSPAA005197
Status last verified
Aug 2026
First submitted
11 May 2023
Last updated
3 Nov 2026
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Acetaminophen/Naproxen Sodium Fixed Combination in people with Pain, run by Johnson & Johnson Consumer Inc. (J&JCI) at 4 sites 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 14 inclusion and 10 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 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 3 Nov 2026). 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 0 to 24 Hours After Dosing (SPID 0-24) (time frame: Baseline (0 hour) up to 24 hours post-dose). 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 NCT05868122.

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 Nov 2026.

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