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JNJ-10450232/ Not yet marketed

Phase 2

Pain | Small molecule | Pain |Johnson & Johnson|Last Updated: Feb 3, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment269

FDA Designations

No designations recorded

Clinical trial landscape

JNJ-10450232/ Not yet marketed · 1 trial · 1 indication

Phase 2 1
NCT02209181A Dental Pain Study to Test the Effectiveness of a New Pain Reliever MedicinePain
COMPLETED269 Analytics
PHASE2COMPLETED
A Dental Pain Study to Test the Effectiveness of a New Pain Reliever Medicine
PainUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

Pain Intensity Difference From Baseline (PID) Scores at 15 Minutes Post Dose
Baseline to 15 minutes post dose
Pain Intensity Difference From Baseline (PID) Scores at 30 Minutes Post Dose
Baseline to 30 minutes post dose
Pain Intensity Difference From Baseline (PID) Scores at 45 Minutes Post Dose
Baseline to 45 minutes post dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
JNJ-10450232 250 mgEXPERIMENTAL -
JNJ-10450232 1000 mgEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Acetaminophen 1000 mgACTIVE_COMPARATOR -

Interventions

NameTypeDescription
JNJ-10450232 / Not yet marketedDRUGSubjects 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 / TylenolDRUGSubjects 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.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 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 Exclusion Criteria: ...

Countries:United States
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Frequently asked questions about JNJ-10450232/ Not yet marketed

What is JNJ-10450232 used for?

JNJ-10450232 is an investigational small molecule being developed for the treatment of pain. It is currently in Phase 2 clinical development and has been studied in a completed trial for pain management.

What does JNJ-10450232 target?

The molecular target of JNJ-10450232 has not been disclosed. It is a small molecule being studied for its pain-relieving effects, but its specific mechanism of action is not publicly available.

Who makes JNJ-10450232?

JNJ-10450232 is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ.

What phase is JNJ-10450232 in?

JNJ-10450232 is in Phase 2 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. One Phase 2 trial has been completed.

What clinical trials is JNJ-10450232 in?

JNJ-10450232 has been studied in one completed Phase 2 clinical trial, NCT02209181, titled 'A Dental Pain Study to Test the Effectiveness of a New Pain Reliever Medicine.' The trial enrolled 269 male participants aged 18 years and older in the United States.

Is JNJ-10450232 the same as any other drug?

No alternative names for JNJ-10450232 have been disclosed. It is identified solely by its investigational code and is not known to be marketed under any other name.