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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02209181
Recruitment Status : Completed
First Posted : August 5, 2014
Results First Posted : February 3, 2017
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. )

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.

Condition or disease Intervention/treatment Phase
Pain Drug: JNJ-10450232 / Not yet marketed Drug: acetaminophen / Tylenol Phase 2

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.

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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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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).

  20. 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).

  21. 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).

  22. 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).

  23. 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).

  24. 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).

  25. 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).

  26. 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).

  27. 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).

  28. 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).

  29. 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).

  30. 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).

  31. 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).

  32. 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).

  33. 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).

  34. 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).

  35. 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).

  36. 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).

  37. 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.

  38. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Investigators
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Principal Investigator: Derek Muse, MD Jean Brown Research
Study Director: Cathy Gelotte, Ph.D. McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

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Responsible Party: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
ClinicalTrials.gov Identifier: NCT02209181     History of Changes
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

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. ):
dental pain
post-surgical dental pain

Additional relevant MeSH terms:
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Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics