Back to resultsA Dental Pain Study to Test the Effectiveness of a New Pain Reliever Medicine
Primary Purpose
Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
JNJ-10450232 / Not yet marketed
JNJ-10450232 / Not yet marketed
JNJ-10450232 / Not yet marketed
acetaminophen / Tylenol
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring dental pain, post-surgical dental pain
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
Sites / Locations
- Jean Brown Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Active Comparator
Arm Label
JNJ-10450232 250 mg
JNJ-10450232 1000 mg
Placebo
Acetaminophen 1000 mg
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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.
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).
Full Information
NCT ID
NCT02209181
First Posted
July 22, 2014
Last Updated
December 10, 2016
Sponsor
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02209181
Brief Title
A Dental Pain Study to Test the Effectiveness of a New Pain Reliever Medicine
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
dental pain, post-surgical dental pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
269 (Actual)
8. Arms, Groups, and Interventions
Arm Title
JNJ-10450232 250 mg
Arm Type
Experimental
Arm Title
JNJ-10450232 1000 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Acetaminophen 1000 mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
JNJ-10450232 / Not yet marketed
Intervention Description
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
Intervention Name(s)
JNJ-10450232 / Not yet marketed
Intervention Description
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
Intervention Name(s)
JNJ-10450232 / Not yet marketed
Intervention Description
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
Intervention Name(s)
acetaminophen / Tylenol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Analgesic Efficacy From 0 to 6 Hours After the Dose Using the Time-weighted Sum of Pain Intensity Difference (SPID 0-6)
Description
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).
Time Frame
6 Hours
Secondary Outcome Measure Information:
Title
Pain Intensity Difference From Baseline (PID) Scores at 15 Minutes Post Dose
Description
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.
Time Frame
Baseline to 15 minutes post dose
Title
Pain Intensity Difference From Baseline (PID) Scores at 30 Minutes Post Dose
Description
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.
Time Frame
Baseline to 30 minutes post dose
Title
Pain Intensity Difference From Baseline (PID) Scores at 45 Minutes Post Dose
Description
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.
Time Frame
Baseline to 45 minutes post dose
Title
Pain Intensity Difference From Baseline (PID) Scores at 1 Hour Post Dose
Description
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.
Time Frame
Baseline to 1 hour post dose
Title
Pain Intensity Difference From Baseline (PID) Scores at 1.5 Hours Post Dose
Description
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.
Time Frame
Baseline to 1.5 hours post dose
Title
Pain Intensity Difference From Baseline (PID) Scores at 2 Hours Post Dose
Description
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.
Time Frame
Baseline to 2 hours post dose
Title
Pain Intensity Difference From Baseline (PID) Scores at 3 Hours Post Dose
Description
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.
Time Frame
Baseline to 3 hours post dose
Title
Pain Intensity Difference From Baseline (PID) Scores at 4 Hours Post Dose
Description
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.
Time Frame
Baseline to 4 hours post dose
Title
Pain Intensity Difference From Baseline (PID) Scores at 5 Hours Post Dose
Description
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.
Time Frame
Baseline to 5 hours post dose
Title
Pain Intensity Difference From Baseline (PID) Scores at 6 Hours Post Dose
Description
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.
Time Frame
Baseline to 6 hours post dose
Title
Pain Intensity Difference From Baseline (PID) Scores at 7 Hours Post Dose
Description
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.
Time Frame
Baseline to 7 hours post dose
Title
Pain Intensity Difference From Baseline (PID) Scores at 8 Hours Post Dose
Description
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.
Time Frame
Baseline to 8 hours post dose
Title
Pain Intensity Difference From Baseline (PID) Scores at 9 Hours Post Dose
Description
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.
Time Frame
Baseline to 9 hours post dose
Title
Pain Intensity Difference From Baseline (PID) Scores at 10 Hours Post Dose
Description
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.
Time Frame
Baseline to 10 hours post dose
Title
Pain Intensity Difference From Baseline (PID) Scores at 11 Hours Post Dose
Description
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.
Time Frame
Baseline to 11 hours post dose
Title
Pain Intensity Difference From Baseline (PID) Scores at 12 Hours Post Dose
Description
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.
Time Frame
Baseline to 12 hours post dose
Title
Pain Intensity Difference From Baseline (PID) Scores at 16 Hours Post Dose
Description
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.
Time Frame
Baseline to 16 hours post dose
Title
Pain Intensity Difference From Baseline (PID) Scores at 24 Hours Post Dose
Description
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.
Time Frame
Baseline to 24 hours post dose
Title
Pain Relief (PAR) Scores at 15 Minutes Post Dose
Description
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame
15 minutes post dose
Title
Pain Relief (PAR) Scores at 30 Minutes Post Dose
Description
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame
30 minutes post dose
Title
Pain Relief (PAR) Scores at 45 Minutes Post Dose
Description
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame
45 minutes post dose
Title
Pain Relief (PAR) Scores at 1 Hour Post Dose
Description
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame
1 hour post dose
Title
Pain Relief (PAR) Scores at 1.5 Hours Post Dose
Description
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame
1.5 hours post dose
Title
Pain Relief (PAR) Scores at 2 Hours Post Dose
Description
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame
2 hours post dose
Title
Pain Relief (PAR) Scores at 3 Hours Post Dose
Description
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame
3 hours post dose
Title
Pain Relief (PAR) Scores at 4 Hours Post Dose
Description
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame
4 hours post dose
Title
Pain Relief (PAR) Scores at 5 Hours Post Dose
Description
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame
5 hours post dose
Title
Pain Relief (PAR) Scores at 6 Hours Post Dose
Description
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame
6 hours post dose
Title
Pain Relief (PAR) Scores at 7 Hours Post Dose
Description
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame
7 hours post dose
Title
Pain Relief (PAR) Scores at 8 Hours Post Dose
Description
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame
8 hours post dose
Title
Pain Relief (PAR) Scores at 9 Hours Post Dose
Description
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame
9 hours post dose
Title
Pain Relief (PAR) Scores at 10 Hours Post Dose
Description
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame
10 hours post dose
Title
Pain Relief (PAR) Scores at 11 Hours Post Dose
Description
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame
11 hours post dose
Title
Pain Relief (PAR) Scores at 12 Hours Post Dose
Description
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame
12 hours post dose
Title
Pain Relief (PAR) Scores at 16 Hours Post Dose
Description
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame
16 hours post dose
Title
Pain Relief (PAR) Scores at 24 Hours Post Dose
Description
Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Time Frame
24 hours post dose
Title
Duration of Pain Relief After Dosing (Time to Rescue Medication)
Description
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.
Time Frame
Completed at time of the first rescue medication (hours post dose), estimated up through Day 2
Title
Subject Global Evaluation
Description
How the subject would rate the study medication as a pain-reliever on a scale of 0-4 (where 0=poor and 4=excellent).
Time Frame
Completed at hour 12 or at time of the first rescue medication (hours post dose).
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derek Muse, MD
Organizational Affiliation
Jean Brown Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cathy Gelotte, Ph.D.
Organizational Affiliation
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Jean Brown Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Dental Pain Study to Test the Effectiveness of a New Pain Reliever Medicine
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