A Dental Pain Study to Test the Effectiveness of a New Pain Reliever Medicine
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ClinicalTrials.gov Identifier: NCT02209181 |
Recruitment Status :
Completed
First Posted : August 5, 2014
Results First Posted : February 3, 2017
Last Update Posted : February 3, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pain | Drug: JNJ-10450232 / Not yet marketed Drug: acetaminophen / Tylenol | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 269 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 Start Date : | August 2014 |
Actual Primary Completion Date : | April 2015 |
Actual Study Completion Date : | April 2015 |
Arm | Intervention/treatment |
---|---|
Experimental: JNJ-10450232 250 mg |
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. |
Experimental: JNJ-10450232 1000 mg |
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. |
Placebo Comparator: Placebo |
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. |
Active Comparator: Acetaminophen 1000 mg |
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. |
- Analgesic Efficacy From 0 to 6 Hours After the Dose Using the Time-weighted Sum of Pain Intensity Difference (SPID 0-6) [ Time Frame: 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).
- Pain Intensity Difference From Baseline (PID) Scores at 15 Minutes Post Dose [ Time Frame: Baseline to 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 [ Time Frame: Baseline to 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 [ Time Frame: Baseline to 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 [ Time Frame: Baseline to 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 [ Time Frame: Baseline to 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 [ Time Frame: Baseline to 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 [ Time Frame: Baseline to 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 [ Time Frame: Baseline to 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 [ Time Frame: Baseline to 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 [ Time Frame: Baseline to 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 [ Time Frame: Baseline to 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 [ Time Frame: Baseline to 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 [ Time Frame: Baseline to 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 [ Time Frame: Baseline to 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 [ Time Frame: Baseline to 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 [ Time Frame: Baseline to 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 [ Time Frame: Baseline to 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 [ Time Frame: Baseline to 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 Frame: Completed at time of the first rescue medication (hours post dose), estimated up through Day 2 ]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 [ Time Frame: Completed at hour 12 or at time of the first rescue medication (hours post dose). ]How the subject would rate the study medication as a pain-reliever on a scale of 0-4 (where 0=poor and 4=excellent).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02209181
United States, Utah | |
Jean Brown Research | |
Salt Lake City, Utah, United States, 84124 |
Principal Investigator: | Derek Muse, MD | Jean Brown Research | |
Study Director: | Cathy Gelotte, Ph.D. | McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. |
Responsible Party: | McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. |
ClinicalTrials.gov Identifier: | NCT02209181 |
Other Study ID Numbers: |
CO-131230135611-CTPA |
First Posted: | August 5, 2014 Key Record Dates |
Results First Posted: | February 3, 2017 |
Last Update Posted: | February 3, 2017 |
Last Verified: | December 2016 |
dental pain post-surgical dental pain |
Toothache Tooth Diseases Stomatognathic Diseases Facial Pain Pain Neurologic Manifestations Acetaminophen |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antipyretics |