PainPhase 2NCT03879408

Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study

A Phase 2 study testing 440 mg naproxen sodium with 1000 mg acetaminophen, 220 mg naproxen sodium with 650 mg acetaminophen and 10 mg hydrocodone + 650 mg acetaminophen in people with Pain, run by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division at 1 site 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

Study assessing efficacy and safety of concomitantly dosed naproxen sodium with acetaminophen, compared with naproxen sodium, hydrocodone/acetaminophen and Placebo in a postoperative dental pain. Read more about this study

Who is it for?: Ages 17 to 50 years
Conditions the study is for: Pain
What is being tested?: 440 mg naproxen sodium with 1000 mg acetaminophen, 220 mg naproxen sodium with 650 mg acetaminophen and 10 mg hydrocodone + 650 mg acetaminophen
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 290 participants
Where: 1 siteUnited States
Study dates: 28 May 2019to 13 Nov 2019
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 of females 17-50 years old
Weigh 100 pounds or greater and have a body mass index (BMI) of 18.5 to 35 (inclusive) at screening
Surgical removal of up to 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 known allergy or hypersensitivity to naproxen or other NSAIDS, including aspirin, or to acetaminophen, tramadol, hydrocodone or other opioids
Not able to swallow 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, substance abuse as judged by investigator site staff within last 5 years
Use of immunosuppressive drugs within 2 weeks of screening
History of peptic ulcer disease or gastrointestinal bleeding in the last two years or hematologic bleeding

Trial locations and contacts

1 site in 1 country.

United States1 site

Jean Brown Research Clinical Research
Salt Lake City, Utah, 84107

Other trials in United States

About this study

Official title: Randomized, Double-Blind, Placebo And Active Controlled, Study To Evaluate Two Strengths Of Concomitantly Dosed Naproxen Sodium With Acetaminophen, Compared With Naproxen Sodium and Hydrocodone/Acetaminophen In Postoperative Dental Pain

Study assessing efficacy and safety of concomitantly dosed naproxen sodium with acetaminophen, compared with naproxen sodium, hydrocodone/acetaminophen and Placebo in a postoperative dental pain.

Read the detailed description

This is a randomized, double-blind, placebo- and active-controlled, parallel-group study to evaluate the analgesic efficacy and safety of concomitantly administered naproxen sodium 440 mg with acetaminophen 1000 mg and concomitantly administered naproxen sodium 220 mg with acetaminophen 650 mg, compared with a fixed combination of hydrocodone 10 mg/acetaminophen 650 mg, naproxen sodium 440 mg, and placebo over a twelve-hour period after surgical extraction of four third molars.

Conditions: Pain
Being tested: 440 mg naproxen sodium with 1000 mg acetaminophen, 220 mg naproxen sodium with 650 mg acetaminophen, 10 mg hydrocodone + 650 mg acetaminophen, 440 mg naproxen sodium, Placebo tablet
Keywords: Analgesics, Dental Pain, Naproxen, Acetaminophen, Pain
Medical subject headings: Pain, Toothache

What participants receive

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

440 mg naproxen sodium with 1000 mg acetaminophenDrug
Also called Naproxen Sodium with Acetaminophen - High Dose
440 mg naproxen sodium with 1000 mg acetaminophen administered as a single dose of two naproxen sodium 220 mg tablets and two acetaminophen 500 mg tablets
220 mg naproxen sodium with 650 mg acetaminophenDrug
Also called Naproxen Sodium with Acetaminophen - Low Dose
220 mg naproxen sodium with 650 mg acetaminophen administered as a single dose of one naproxen sodium 220 mg tablet and two acetaminophen 325 mg tablets and one placebo tablet
10 mg hydrocodone + 650 mg acetaminophenDrug
Also called Commercial Hydrocodone + Acetaminophen Tablet
10 mg hydrocodone with 650 mg acetaminophen administered as a single dose of two hydrocodone 5 mg + acetaminophen 325 mg tablets and two placebo tablets
440 mg naproxen sodiumDrug
Also called Naproxen sodium
440 mg naproxen sodium administered as a single dose of two naproxen sodium 220 mg tablets and two placebo tablets
Placebo tabletDrug
Single dose of four placebo tablets

Study groups in NCT03879408
Study group	Role	What they receive
440 mg naproxen sodium with 1000 mg acetaminophen	Experimental	440 mg naproxen sodium with 1000 mg acetaminophen administered as a single dose of two naproxen sodium 220 mg tablets and two acetaminophen 500 mg tablets Receives: Drug: 440 mg naproxen sodium with 1000 mg acetaminophen
220 mg naproxen sodium with 650 mg acetaminophen	Experimental	220 mg naproxen sodium with 650 mg acetaminophen administered as a single dose of one naproxen sodium 220 mg tablet and two acetaminophen 325 mg tablets and one placebo tablet Receives: Drug: 220 mg naproxen sodium with 650 mg acetaminophen
10 mg hydrocodone + 650 mg acetaminophen	Active comparator	10 mg hydrocodone + 650 mg acetaminophen administered as a single dose of two hydrocodone 5 mg + acetaminophen 325 mg tablets and two placebo tablets Receives: Drug: 10 mg hydrocodone + 650 mg acetaminophen
440 mg naproxen sodium	Active comparator	440 mg naproxen sodium administered as a single dose of two naproxen sodium 220 mg tablets and two placebo tablets Receives: Drug: 440 mg naproxen sodium
Placebo tablet	Placebo comparator	Single dose of four placebo tablets Receives: Drug: Placebo tablet

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 6 Hours (SPID 0-6)
Time-weighted sum of the pain intensity difference (SPID) score was measured using a Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain). The possible range of SPID for 0-6 hours was from -60 to 60. A higher value of SPID indicated greater pain relief. PID was the difference between baseline pain intensity and pain intensity at assessment. Time-weighted sum of the pain intensity difference 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 0 to 6 hours.
Measured: Baseline (0 hour) up to 6 hours post-dose
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 score was measured using a PI-NRS ranging from 0-10 (0 = no pain, 10 = very severe pain). The possible range of SPID for 0-12 hours was from -120 to 120. A higher value of SPID indicated greater pain relief. PID was the difference between baseline pain intensity and pain intensity at assessment (12 hours). Time-weighted sum of the pain intensity difference 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 0 to 12 hours.
Measured: Baseline (0 hour) up to 12 hours post-dose

Secondary outcomes (7)

Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 6 Hours (TOTPAR 0-6)
Time-weighted total pain relief (TOTPAR) was measured using a Pain Relief Numerical Rating Scale (PR-NRS) ranging from 0-10 (0 = no relief, 10 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose 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 60. Higher scores was indicative of more pain relief.
Measured: Baseline (0 hour) up to 6 hours post-dose
Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 8 Hours (TOTPAR 0-8)
TOTPAR was measured using a PR-NRS ranging from 0-10 (0 = no relief, 10 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose 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 80. Higher scores was indicative of more pain relief.
Measured: Baseline (0 hour) up to 8 hours post-dose
Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 12 Hours (TOTPAR 0-12)
TOTPAR was measured using a PR-NRS ranging from 0-10 (0 = no relief, 10 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose 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 was indicative of more pain relief.
Measured: Baseline (0 hour) up to 12 hours post-dose
Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 8 Hours (SPID 0-8)
Time-weighted sum of the pain intensity difference score was measured using a PI-NRS ranging from 0-10 (0 = no pain, 10 = very severe pain). The possible range of SPID for 0-8 hours was from -80 to 80. A higher value of SPID indicated greater pain relief. PID was the difference between baseline pain intensity and pain intensity at assessment (8 hours). Time-weighted sum of the pain intensity difference 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 0 to 8 hours.
Measured: Baseline (0 hour) up to 8 hours post-dose
Pain Relief (PAR) Scores at Individual Timepoints
Participants answered a question at individual time points: "how much relief do you have from your starting pain?" on a 11-point PR-NRS. Scale ranged from 0=no relief to 10=complete relief. Higher score indicated improvement in pain.
Measured: 0.25 hours, 0.5 hours, 0.75 hours, 1 hours, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, and 12 hours
Pain Intensity Difference (PID) Scores at Individual Time Points
Pain Intensity was self-reported over 12 hours, using a pain rating of 0-10 on the PI-NRS, with score ranged from 0-10 (0= no pain; 10 = worst imaginable pain). Pain intensity differences were calculated with respect to baseline at each time point after study drug administration.
Measured: 0.25 hours, 0.5 hours, 0.75 hours, 1 hours, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, and 12 hours
Participant's Global Evaluation of Study Medication OR Overall Impression of Study Medication According to Participant's Global Evaluation
Participants were asked to rate their overall impression of the study medication using the following scale: poor (0), fair (1), good (2), very good (3), and excellent (4) where higher score represented better outcome.
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.

28 May 201913 Nov 2019

First posted18 Mar 2019
Study start28 May 2019
Primary completion7 Nov 2019
Study completion13 Nov 2019

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: 290 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03879408
Sponsor's protocol ID: CCSPAA001068
Status last verified: Nov 2022
First submitted: 1 Mar 2019
Last updated: 5 Dec 2022
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-Blind, Placebo And Active Controlled, Study To Evaluate Two Strengths Of Concomitantly Dosed Naproxen Sodium With Acetaminophen, Compared With Naproxen Sodium and Hydrocodone/Acetaminophen In Postoperative Dental Pain
ClinicalTrials.gov ID: NCT03879408
Acronym / sponsor ID: CCSPAA001068
Conditions: Pain
Keywords: Analgesics, Dental Pain, Naproxen, Acetaminophen, Pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 290 participants (actual)
Lead sponsor: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionIndustry (pharma, biotech, devices)
Study start: 28 May 2019 (actual)
Primary completion: 7 Nov 2019 (actual)
Study completion: 13 Nov 2019 (actual)
First posted: 18 Mar 2019 (actual)
Results: Posted 5 Dec 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study assessing efficacy and safety of concomitantly dosed naproxen sodium with acetaminophen, compared with naproxen sodium, hydrocodone/acetaminophen and Placebo in a postoperative dental pain.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5
Model description: Post-operative dental pain following third molar extraction.

Arm	Type	Receives
440 mg naproxen sodium with 1000 mg acetaminophen	Experimental	Drug: 440 mg naproxen sodium with 1000 mg acetaminophen440 mg naproxen sodium with 1000 mg acetaminophen administered as a single dose of two naproxen sodium 220 mg tablets and two acetaminophen 500 mg tablets
220 mg naproxen sodium with 650 mg acetaminophen	Experimental	Drug: 220 mg naproxen sodium with 650 mg acetaminophen220 mg naproxen sodium with 650 mg acetaminophen administered as a single dose of one naproxen sodium 220 mg tablet and two acetaminophen 325 mg tablets and one placebo tablet
10 mg hydrocodone + 650 mg acetaminophen	Active comparator	Drug: 10 mg hydrocodone + 650 mg acetaminophen10 mg hydrocodone + 650 mg acetaminophen administered as a single dose of two hydrocodone 5 mg + acetaminophen 325 mg tablets and two placebo tablets
440 mg naproxen sodium	Active comparator	Drug: 440 mg naproxen sodium440 mg naproxen sodium administered as a single dose of two naproxen sodium 220 mg tablets and two placebo tablets
Placebo tablet	Placebo comparator	Drug: Placebo tabletSingle dose of four placebo tablets

Who may qualify

Ages: 17 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

Males of females 17-50 years old
Weigh 100 pounds or greater and have a body mass index (BMI) of 18.5 to 35 (inclusive) at screening
Surgical removal of up to 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 known allergy or hypersensitivity to naproxen or other NSAIDS, including aspirin, or to acetaminophen, tramadol, hydrocodone or other opioids
Not able to swallow 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
440 mg naproxen sodium with 1000 mg acetaminophenAlso: Naproxen Sodium with Acetaminophen - High Dose440 mg naproxen sodium with 1000 mg acetaminophen administered as a single dose of two naproxen sodium 220 mg tablets and two acetaminophen 500 mg tablets	Drug	440 mg naproxen sodium with 1000 mg acetaminophen
220 mg naproxen sodium with 650 mg acetaminophenAlso: Naproxen Sodium with Acetaminophen - Low Dose220 mg naproxen sodium with 650 mg acetaminophen administered as a single dose of one naproxen sodium 220 mg tablet and two acetaminophen 325 mg tablets and one placebo tablet	Drug	220 mg naproxen sodium with 650 mg acetaminophen
10 mg hydrocodone + 650 mg acetaminophenAlso: Commercial Hydrocodone + Acetaminophen Tablet10 mg hydrocodone with 650 mg acetaminophen administered as a single dose of two hydrocodone 5 mg + acetaminophen 325 mg tablets and two placebo tablets	Drug	10 mg hydrocodone + 650 mg acetaminophen
440 mg naproxen sodiumAlso: Naproxen sodium440 mg naproxen sodium administered as a single dose of two naproxen sodium 220 mg tablets and two placebo tablets	Drug	440 mg naproxen sodium
Placebo tabletSingle dose of four placebo tablets	Drug	Placebo tablet

Primary outcome

Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 6 Hours (SPID 0-6)
Time frame: Baseline (0 hour) up to 6 hours post-dose
Time-weighted sum of the pain intensity difference (SPID) score was measured using a Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain). The possible range of SPID for 0-6 hours was from -60 to 60. A higher value of SPID indicated greater pain relief. PID was the difference between baseline pain intensity and pain intensity at assessment. Time-weighted sum of the pain intensity difference 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 0 to 6 hours.
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
Time-weighted sum of the pain intensity difference score was measured using a PI-NRS ranging from 0-10 (0 = no pain, 10 = very severe pain). The possible range of SPID for 0-12 hours was from -120 to 120. A higher value of SPID indicated greater pain relief. PID was the difference between baseline pain intensity and pain intensity at assessment (12 hours). Time-weighted sum of the pain intensity difference 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 0 to 12 hours.

7 secondary outcomes

Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 6 Hours (TOTPAR 0-6)
Time frame: Baseline (0 hour) up to 6 hours post-dose
Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 8 Hours (TOTPAR 0-8)
Time frame: Baseline (0 hour) up to 8 hours post-dose
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
Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 8 Hours (SPID 0-8)
Time frame: Baseline (0 hour) up to 8 hours post-dose
Pain Relief (PAR) Scores at Individual Timepoints
Time frame: 0.25 hours, 0.5 hours, 0.75 hours, 1 hours, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, and 12 hours
Pain Intensity Difference (PID) Scores at Individual Time Points
Time frame: 0.25 hours, 0.5 hours, 0.75 hours, 1 hours, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, and 12 hours
Participant's Global Evaluation of Study Medication OR Overall Impression of Study Medication According to Participant's Global Evaluation
Time frame: Up to 12 hours

Results and safety

Results posted to the registry on 5 Dec 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1: Placebo	35	33
Arm 2: Naproxen Sodium 440 mg	69	65
Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg	61	58
Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg	63	62
Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg	62	61

Primary outcome: Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 6 Hours (SPID 0-6)

Time frame: Baseline (0 hour) up to 6 hours post-dose. Least squares mean (Standard Error). Unit: Units on a scale

Measure	Arm 1: Placebo n = 35	Arm 2: Naproxen Sodium 440 mg n = 69	Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg n = 61	Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg n = 63	Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg n = 62
Value	2.36 (2.181)	25.59 (1.562)	30.28 (1.677)	33.77 (1.633)	23.60 (1.651)

Population analysed: Intent-to-Treat (ITT) analysis set included all randomized participants.

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. Least squares mean (Standard Error). Unit: Units on a scale

Measure	Arm 1: Placebo n = 35	Arm 2: Naproxen Sodium 440 mg n = 69	Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg n = 61	Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg n = 63	Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg n = 62
Value	5.80 (4.666)	50.07 (3.341)	55.47 (3.587)	66.43 (3.494)	39.94 (3.533)

Population analysed: ITT analysis set included all randomized participants.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Day 10. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1: Placebo	0 of 35 (0%)	14 of 35 (40%)	0 of 35
Arm 2: Naproxen Sodium 440 mg	0 of 69 (0%)	5 of 69 (7.2%)	0 of 69
Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg	0 of 61 (0%)	8 of 61 (13.1%)	0 of 61
Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg	0 of 63 (0%)	9 of 63 (14.3%)	0 of 63
Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg	0 of 62 (0%)	22 of 62 (35.5%)	0 of 62

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
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.

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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.

Todd Bertoch, MD principal investigator

Jean Brown Research (JBR)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 Dec 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 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 5 Dec 2022). 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 6 Hours (SPID 0-6) (time frame: Baseline (0 hour) up to 6 hours post-dose). The study lists 2 primary outcomes in all. 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 NCT03879408.

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 5 Dec 2022.