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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02209181
• Other study ID #: CO-131230135611-CTPA
• Status: Completed
• Phase: Phase 2
• First received: July 22, 2014
• Last updated: January 28, 2016
• Start date: August 2014
• Est. completion date: April 2015

Study information

• Verified date: January 2016
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Toothache

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Jean Brown Research	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary: 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. Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain).	SPID 0-6	No
Secondary	Pain intensity difference from baseline (PID) scores	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.	Baseline to 24 hours post dose	No
Secondary	Pain relief (PAR) scores at each time point	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).	Baseline to 24 hours post dose	No
Secondary	Duration of pain relief after dosing (time to rescue medication)	Time to rescue medication will be measured as the elapsed time from when the investigational product was given until the time rescue medication was given.	Completed at time of the first rescue medication (hours postdose), estimated up through Day 2.	No
Secondary	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).	Completed at hour 12 or at time of the first rescue medication (hours postdose), estimated up through Day 2.	No