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Completed

NCT Number: NCT02209181

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

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.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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 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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 5, 2014
Registry last updated
Feb 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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