PainPhase 2NCT02209181

A Dental Pain Study to Test the Effectiveness of a New Pain Reliever Medicine

A Phase 2 study testing JNJ-10450232 / Not yet marketed and acetaminophen / Tylenol in people with Pain, run by McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. 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

To assess the safety and effectiveness one dose of a new pain reliever medicine (JNJ-10450232 at either the 250 or 1000 mg strength) compared with placebo (sugar pill) or acetaminophen 1000 mg after surgical removal of third molars. Read more about this study

Who is it for?: Ages 18 to 45 years, men only
Conditions the study is for: Pain
What is being tested?: JNJ-10450232 / Not yet marketed and acetaminophen / Tylenol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 269 participants
Where: 1 siteUnited States
Study dates: Aug 2014to Apr 2015
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 18 to 45 years
Men only
No healthy volunteers
Adult

Who may be able to join

Subjects aged 18-45 years
At least moderate dental pain assessed by a categorical scale pain intensity scale and a score of at least 5 on the 11-point (0-10) pain intensity numerical rating scale (PI-NRS) following surgical removal of three third-molars

Who cannot join

Subjects who are not otherwise healthy
Test positive for the urine drug screen
Taking prohibited medications will not be allowed to participate in this study

Trial locations and contacts

1 site in 1 country.

United States1 site

Jean Brown Research
Salt Lake City, Utah, 84124

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo- and Active-controlled Trial to Investigate the Single-dose Efficacy, Safety, and Pharmacokinetics of 250 and 1000 mg JNJ-10450232 in Postoperative Dental Pain

Read the detailed description

This is a single-center, randomized, double-blind, placebo- and active-controlled, parallel group study to evaluate the efficacy, safety and pharmacokinetic profile of JNJ-10450232, administered as a single dose in capsules (250 or 1000 mg), over a 24 hour period after molar extractions. Subjects will stay at the research center for ~24 hours after administration of study drug. Healthy male subjects, ages 18 to 45 years inclusive, will be screened by medical history, vital signs, an electrocardiogram (ECG), and clinical laboratory tests. Eligible subjects will return to the clinic on the day of surgery and complete baseline vital signs and clinical laboratory tests. They will undergo dental extraction of a minimum of three third-molars and, if qualified, will be randomly assigned to one of four study treatments for pain.

Conditions: Pain
Being tested: JNJ-10450232 / Not yet marketed, acetaminophen / Tylenol
Keywords: dental pain, post-surgical dental 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.

JNJ-10450232 / Not yet marketedDrug
Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.
JNJ-10450232 / Not yet marketedDrug
Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.
JNJ-10450232 / Not yet marketedDrug
Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.
acetaminophen / TylenolDrug
Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.

Study groups in NCT02209181
Study group	Role	What they receive
JNJ-10450232 250 mg	Experimental	Not described Receives: Drug: JNJ-10450232 / Not yet marketed
JNJ-10450232 1000 mg	Experimental	Not described Receives: Drug: JNJ-10450232 / Not yet marketed
Placebo	Placebo comparator	Not described Receives: Drug: JNJ-10450232 / Not yet marketed
Acetaminophen 1000 mg	Active comparator	Not described Receives: Drug: acetaminophen / Tylenol

What is being measured

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

Analgesic Efficacy From 0 to 6 Hours After the Dose Using the Time-weighted Sum of Pain Intensity Difference (SPID 0-6)
Time-weighted sum of pain intensity difference by first multiplying each pain intensity difference (PID) score by the time from the previous time point, and adding them together for each scheduled time point within 0-6 hours. Time points included 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours. The minimum SPID 0-6 was -30 and the maximum SPID 0-6 was 60, where higher is better. Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain).
Measured: 6 Hours

Secondary outcomes (38)

Pain Intensity Difference From Baseline (PID) Scores at 15 Minutes Post Dose
Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Measured: Baseline to 15 minutes post dose
Pain Intensity Difference From Baseline (PID) Scores at 30 Minutes Post Dose
Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Measured: Baseline to 30 minutes post dose
Pain Intensity Difference From Baseline (PID) Scores at 45 Minutes Post Dose
Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Measured: Baseline to 45 minutes post dose
Pain Intensity Difference From Baseline (PID) Scores at 1 Hour Post Dose
Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Measured: Baseline to 1 hour post dose
Pain Intensity Difference From Baseline (PID) Scores at 1.5 Hours Post Dose
Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Measured: Baseline to 1.5 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 2 Hours Post Dose
Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Measured: Baseline to 2 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 3 Hours Post Dose
Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Measured: Baseline to 3 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 4 Hours Post Dose
Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Measured: Baseline to 4 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 5 Hours Post Dose
Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Measured: Baseline to 5 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 6 Hours Post Dose
Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Measured: Baseline to 6 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 7 Hours Post Dose
Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Measured: Baseline to 7 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 8 Hours Post Dose
Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Measured: Baseline to 8 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 9 Hours Post Dose
Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Measured: Baseline to 9 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 10 Hours Post Dose
Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Measured: Baseline to 10 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 11 Hours Post Dose
Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Measured: Baseline to 11 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 12 Hours Post Dose
Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Measured: Baseline to 12 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 16 Hours Post Dose
Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Measured: Baseline to 16 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 24 Hours Post Dose
Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Measured: Baseline to 24 hours post dose
Pain Relief (PAR) Scores at 15 Minutes Post Dose
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Measured: 15 minutes post dose
Pain Relief (PAR) Scores at 30 Minutes Post Dose
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Measured: 30 minutes post dose
Pain Relief (PAR) Scores at 45 Minutes Post Dose
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Measured: 45 minutes post dose
Pain Relief (PAR) Scores at 1 Hour Post Dose
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Measured: 1 hour post dose
Pain Relief (PAR) Scores at 1.5 Hours Post Dose
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Measured: 1.5 hours post dose
Pain Relief (PAR) Scores at 2 Hours Post Dose
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Measured: 2 hours post dose
Pain Relief (PAR) Scores at 3 Hours Post Dose
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Measured: 3 hours post dose
Pain Relief (PAR) Scores at 4 Hours Post Dose
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Measured: 4 hours post dose
Pain Relief (PAR) Scores at 5 Hours Post Dose
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Measured: 5 hours post dose
Pain Relief (PAR) Scores at 6 Hours Post Dose
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Measured: 6 hours post dose
Pain Relief (PAR) Scores at 7 Hours Post Dose
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Measured: 7 hours post dose
Pain Relief (PAR) Scores at 8 Hours Post Dose
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Measured: 8 hours post dose
Pain Relief (PAR) Scores at 9 Hours Post Dose
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Measured: 9 hours post dose
Pain Relief (PAR) Scores at 10 Hours Post Dose
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Measured: 10 hours post dose
Pain Relief (PAR) Scores at 11 Hours Post Dose
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Measured: 11 hours post dose
Pain Relief (PAR) Scores at 12 Hours Post Dose
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Measured: 12 hours post dose
Pain Relief (PAR) Scores at 16 Hours Post Dose
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Measured: 16 hours post dose
Pain Relief (PAR) Scores at 24 Hours Post Dose
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Measured: 24 hours post dose
Duration of Pain Relief After Dosing (Time to Rescue Medication)
Time (minutes) to rescue medication was measured as the elapsed time from when the investigational product was given until the time rescue medication was given.
Measured: Completed at time of the first rescue medication (hours post dose), estimated up through Day 2
Subject Global Evaluation
How the subject would rate the study medication as a pain-reliever on a scale of 0-4 (where 0=poor and 4=excellent).
Measured: Completed at hour 12 or at time of the first rescue medication (hours post dose).

Timeline

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

Aug 2014Apr 2015

First posted5 Aug 2014 (estimated)
Study startAug 2014
Primary completionApr 2015
Study completionApr 2015

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.
Publications (1)Papers the sponsor has linked to this study.
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
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 269 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02209181
Sponsor's protocol ID: CO-131230135611-CTPA
Status last verified: Dec 2016
First submitted: 22 Jul 2014
Last updated: 3 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Gelotte CK, Vakil AM, Zimmerman BA, Zannikos P, Mishra R, Eichenbaum G, Kuffner EK, Flores CM. JNJ-10450232 (NTM-006), A novel non-opioid with structural similarities to acetaminophen, produces relatively long-lasting analgesia after a single dose in patients undergoing 3rd molar extraction. Regul Toxicol Pharmacol. 2025 Sep;161 Suppl 1:105480. doi: 10.1016/j.yrtph.2023.105480. Epub 2023 Aug 23.
PubMed 37625518

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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Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo- and Active-controlled Trial to Investigate the Single-dose Efficacy, Safety, and Pharmacokinetics of 250 and 1000 mg JNJ-10450232 in Postoperative Dental Pain
ClinicalTrials.gov ID: NCT02209181
Acronym / sponsor ID: CO-131230135611-CTPA
Conditions: Pain
Keywords: dental pain, post-surgical dental pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 269 participants (actual)
Lead sponsor: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.Industry (pharma, biotech, devices)
Study start: Aug 2014
Primary completion: Apr 2015 (actual)
Study completion: Apr 2015 (actual)
First posted: 5 Aug 2014 (estimated)
Results: Posted 3 Feb 2017

Clinical summary

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

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: 4

Arm	Type	Receives
JNJ-10450232 250 mg	Experimental	Drug: JNJ-10450232 / Not yet marketed
JNJ-10450232 1000 mg	Experimental	Drug: JNJ-10450232 / Not yet marketed
Placebo	Placebo comparator	Drug: JNJ-10450232 / Not yet marketed
Acetaminophen 1000 mg	Active comparator	Drug: acetaminophen / Tylenol

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Subjects aged 18-45 years
At least moderate dental pain assessed by a categorical scale pain intensity scale and a score of at least 5 on the 11-point (0-10) pain intensity numerical rating scale (PI-NRS) following surgical removal of three third-molars

Key exclusion criteria (3 listed)

Subjects who are not otherwise healthy
Test positive for the urine drug screen
Taking prohibited medications will not be allowed to participate in this 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
JNJ-10450232 / Not yet marketedSubjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.	Drug	JNJ-10450232 250 mg
JNJ-10450232 / Not yet marketedSubjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.	Drug	JNJ-10450232 1000 mg
JNJ-10450232 / Not yet marketedSubjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.	Drug	Placebo
acetaminophen / TylenolSubjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.	Drug	Acetaminophen 1000 mg

Primary outcome

Analgesic Efficacy From 0 to 6 Hours After the Dose Using the Time-weighted Sum of Pain Intensity Difference (SPID 0-6)
Time frame: 6 Hours
Time-weighted sum of pain intensity difference by first multiplying each pain intensity difference (PID) score by the time from the previous time point, and adding them together for each scheduled time point within 0-6 hours. Time points included 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours. The minimum SPID 0-6 was -30 and the maximum SPID 0-6 was 60, where higher is better. Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain).

38 secondary outcomes

Pain Intensity Difference From Baseline (PID) Scores at 15 Minutes Post Dose
Time frame: Baseline to 15 minutes post dose
Pain Intensity Difference From Baseline (PID) Scores at 30 Minutes Post Dose
Time frame: Baseline to 30 minutes post dose
Pain Intensity Difference From Baseline (PID) Scores at 45 Minutes Post Dose
Time frame: Baseline to 45 minutes post dose
Pain Intensity Difference From Baseline (PID) Scores at 1 Hour Post Dose
Time frame: Baseline to 1 hour post dose
Pain Intensity Difference From Baseline (PID) Scores at 1.5 Hours Post Dose
Time frame: Baseline to 1.5 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 2 Hours Post Dose
Time frame: Baseline to 2 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 3 Hours Post Dose
Time frame: Baseline to 3 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 4 Hours Post Dose
Time frame: Baseline to 4 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 5 Hours Post Dose
Time frame: Baseline to 5 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 6 Hours Post Dose
Time frame: Baseline to 6 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 7 Hours Post Dose
Time frame: Baseline to 7 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 8 Hours Post Dose
Time frame: Baseline to 8 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 9 Hours Post Dose
Time frame: Baseline to 9 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 10 Hours Post Dose
Time frame: Baseline to 10 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 11 Hours Post Dose
Time frame: Baseline to 11 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 12 Hours Post Dose
Time frame: Baseline to 12 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 16 Hours Post Dose
Time frame: Baseline to 16 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 24 Hours Post Dose
Time frame: Baseline to 24 hours post dose
Pain Relief (PAR) Scores at 15 Minutes Post Dose
Time frame: 15 minutes post dose
Pain Relief (PAR) Scores at 30 Minutes Post Dose
Time frame: 30 minutes post dose
Pain Relief (PAR) Scores at 45 Minutes Post Dose
Time frame: 45 minutes post dose
Pain Relief (PAR) Scores at 1 Hour Post Dose
Time frame: 1 hour post dose
Pain Relief (PAR) Scores at 1.5 Hours Post Dose
Time frame: 1.5 hours post dose
Pain Relief (PAR) Scores at 2 Hours Post Dose
Time frame: 2 hours post dose
Pain Relief (PAR) Scores at 3 Hours Post Dose
Time frame: 3 hours post dose
Pain Relief (PAR) Scores at 4 Hours Post Dose
Time frame: 4 hours post dose
Pain Relief (PAR) Scores at 5 Hours Post Dose
Time frame: 5 hours post dose
Pain Relief (PAR) Scores at 6 Hours Post Dose
Time frame: 6 hours post dose
Pain Relief (PAR) Scores at 7 Hours Post Dose
Time frame: 7 hours post dose
Pain Relief (PAR) Scores at 8 Hours Post Dose
Time frame: 8 hours post dose
Pain Relief (PAR) Scores at 9 Hours Post Dose
Time frame: 9 hours post dose
Pain Relief (PAR) Scores at 10 Hours Post Dose
Time frame: 10 hours post dose
Pain Relief (PAR) Scores at 11 Hours Post Dose
Time frame: 11 hours post dose
Pain Relief (PAR) Scores at 12 Hours Post Dose
Time frame: 12 hours post dose
Pain Relief (PAR) Scores at 16 Hours Post Dose
Time frame: 16 hours post dose
Pain Relief (PAR) Scores at 24 Hours Post Dose
Time frame: 24 hours post dose
Duration of Pain Relief After Dosing (Time to Rescue Medication)
Time frame: Completed at time of the first rescue medication (hours post dose), estimated up through Day 2
Subject Global Evaluation
Time frame: Completed at hour 12 or at time of the first rescue medication (hours post dose).

Results and safety

Results posted to the registry on 3 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	67	66
Acetaminophen 1000 mg	67	66
JNJ-10450232 250 mg	69	68
JNJ-10450232 1000 mg	66	66

Primary outcome: Analgesic Efficacy From 0 to 6 Hours After the Dose Using the Time-weighted Sum of Pain Intensity Difference (SPID 0-6)

Time frame: 6 Hours. Least squares mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 67	Acetaminophen 1000 mg n = 67	JNJ-10450232 250 mg n = 69	JNJ-10450232 1000 mg n = 66
Value	4.37 (1.783)	20.75 (1.783)	8.95 (1.757)	20.56 (1.797)

Placebo vs Acetaminophen 1000 mg: Least Squares Mean Difference: 16.38 (95% CI 11.42 to 21.35), p <0.001, ANOVA
Placebo vs JNJ-10450232 250 mg: Least Squares Mean Difference: 4.58 (95% CI -0.35 to 9.51), p = 0.068, ANOVA
Placebo vs JNJ-10450232 1000 mg: Least Squares Mean Difference: 16.20 (95% CI 11.21 to 21.18), p <0.001, ANOVA

Population analysed: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

38 secondary outcomes are reported in the full results.

Adverse events

Time frame: Within 7 days after dental surgery, +30 days for serious adverse events.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 67 (0%)	3 of 67 (4.5%)	Not reported
Acetaminophen 1000 mg	0 of 67 (0%)	5 of 67 (7.5%)	Not reported
JNJ-10450232 250 mg	0 of 69 (0%)	3 of 69 (4.3%)	Not reported
JNJ-10450232 1000 mg	0 of 66 (0%)	5 of 66 (7.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37625518Gelotte CK, Vakil AM, Zimmerman BA, Zannikos P, Mishra R, Eichenbaum G, Kuffner EK, Flores CM. JNJ-10450232 (NTM-006), A novel non-opioid with structural similarities to acetaminophen, produces relatively long-lasting analgesia after a single dose in patients undergoing 3rd molar extraction. Regul Toxicol Pharmacol. 2025 Sep;161 Suppl 1:105480. doi: 10.1016/j.yrtph.2023.105480. Epub 2023 Aug 23.

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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.

Derek Muse, MD principal investigator

Jean Brown Research

Cathy Gelotte, Ph.D. 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 JNJ-10450232 / Not yet marketed and acetaminophen / Tylenol in people with Pain, run by McNeil Consumer Healthcare 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 2 inclusion and 3 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 Feb 2017. 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 3 Feb 2017). 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?

Analgesic Efficacy From 0 to 6 Hours After the Dose Using the Time-weighted Sum of Pain Intensity Difference (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?

On the ClinicalTrials.gov record for NCT02209181, which also lists 1 linked publication.

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 Feb 2017.