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

NCT ID: NCT02209181

Last Updated: 2017-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 269 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-04-30

Brief 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. The primary endpoint will evaluate pain relief effectiveness up to 6 hours after administration of the study drug.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

JNJ-10450232 250 mg

Group Type: EXPERIMENTAL

JNJ-10450232 / Not yet marketed

Intervention Type: DRUG

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 1000 mg

Group Type: EXPERIMENTAL

JNJ-10450232 / Not yet marketed

Intervention Type: DRUG

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.

Placebo

Group Type: PLACEBO_COMPARATOR

JNJ-10450232 / Not yet marketed

Intervention Type: DRUG

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 1000 mg

Group Type: ACTIVE_COMPARATOR

acetaminophen / Tylenol

Intervention Type: DRUG

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.

Interventions

JNJ-10450232 / Not yet marketed

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.

Intervention Type: DRUG

JNJ-10450232 / Not yet marketed

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.

Intervention Type: DRUG

JNJ-10450232 / Not yet marketed

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.

Intervention Type: DRUG

acetaminophen / Tylenol

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.

Intervention Type: DRUG

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Derek Muse, MD

Role: PRINCIPAL_INVESTIGATOR

Jean Brown Research

Cathy Gelotte, Ph.D.

Role: STUDY_DIRECTOR

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

Locations

Jean Brown Research

Salt Lake City, Utah, United States

Countries

United States

References

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. 2023 Aug 23:105480. doi: 10.1016/j.yrtph.2023.105480. Online ahead of print.

Reference Type: DERIVED

PMID: 37625518 (View on PubMed)

Other Identifiers

CO-131230135611-CTPA

Identifier Type: -

Identifier Source: org_study_id