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

NCT02209181 | Completed Phase 2 Results

• 1 other identifier: CO-131230135611-CTPA
• Study Type: interventional
• Target: 269
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

dental pain; post-surgical dental pain

Outcome Measures

Primary Outcomes (1)

• 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).

  6 Hours

Secondary Outcomes (38)

• 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

• Pain Intensity Difference From Baseline (PID) Scores at 1 Hour Post Dose

  Baseline to 1 hour post dose

• Pain Intensity Difference From Baseline (PID) Scores at 1.5 Hours Post Dose

  Baseline to 1.5 hours post dose

Study Arms (4)

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

Interventions

JNJ-10450232 / Not yet marketed 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 250 mg

acetaminophen / Tylenol 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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.: lead

Study Sites (1)

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

Related Publications (1)

• 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.

  PMID: 37625518 DERIVED

MeSH Terms

Conditions

Pain; Toothache

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tooth Diseases; Stomatognathic Diseases; Facial Pain

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Joseph Aquilina, MD, Senior Director, Clinical Research
• Organization: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

JAquilin@its.jnj.com

(215) 273-8025

Study Officials

• Derek Muse, MD

  Jean Brown Research

  PRINCIPAL INVESTIGATOR

• Cathy Gelotte, Ph.D.

  McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: August 5, 2014
• Study Start: August 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: February 3, 2017
• Results First Posted: February 3, 2017

Record last verified: 2016-12

Locations

US (1)