check_circleStudy Completed

Pain, Postoperative

Study to find out the optimal dose of Caffeine in the combination tablet of Naproxen Sodium and Caffeine in patients experiencing moderate to severe pain after having wisdom teeth removed

Trial purpose

The researchers in this study wanted to find out the optimal dose of Caffeine in the combination tablet of Naproxen Sodium and Caffeine that works in patients experiencing moderate to severe pain after having wisdom teeth removed. In the US, Naproxen has been marketed since 1976, and Naproxen Sodium has been approved for over-the-counter (OTC) use since 1994 for the temporary relief of minor aches and pains. Caffeine, which is generally consumed as coffee, tea or cocoa, has been shown to enhance the effectiveness of various pain relievers, and therefore is accepted as an additive to painkillers like aspirin and acetaminophen. Patients participating in this study underwent a surgery to remove 3 or 4 wisdom teeth. If the pain severity after the surgery met the study requirement, patients would receive oral tablet(s) of Naproxen Sodium and Caffeine, or Naproxen Sodium, or Caffeine, or placebo (drug with no active ingredient). Patients could also receive additional pain medication when needed. Researchers would also learn if the patients have any medical problems during the study.

Key Participants Requirements

Sex

All

Age

16 - N/A

Trial summary

Enrollment Goal
193
Trial Dates
November 2019 - March 2020
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Naproxen sodium and caffeine (BAY2880376)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
JBR Clinical ResearchSalt Lake City, 84107, United States

Primary Outcome

  • Sum of pain intensity difference (SPID) over 8 hours
    Pain intensity is measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each post dose time point, pain intensity difference (PID) is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score – post-baseline score). A positive difference is indicative of improvement. Sum of Pain Intensity Differences (SPIDs) was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 8 hours ranges from -80 to 80. A higher value indicates a better pain reduction.
    date_rangeTime Frame:
    Up to 8 hours post dose

Secondary Outcome

  • Sum of pain intensity differences (SPIDs) from 0 to 2, 4 and 12 hours post-dose
    Pain intensity is measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each post dose time point, pain intensity difference (PID) is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score – post-baseline score). A positive difference is indicative of improvement. Sum of Pain Intensity Differences (SPIDs) was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID 0-2 ranges from -20 to 20, SPID 0-4 ranges from -40 to 40 and SPID 0-12 ranges from -120 to 120. A higher value indicates a better pain reduction.
    date_rangeTime Frame:
    Up to 2 hours, 4 hours and 12 hours post dose
  • Total pain relief (TOTPAR) over 8 hours
    Pain relief is measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total Pain Relief is calculated as the area under the curve of pain relief score over time for the given time period by multiplying the pain relief score at each time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. TOTPAR over 8 hours ranges from 0 to 32, a higher value indicates more pain relief.
    date_rangeTime Frame:
    Up to 8 hours post dose
  • Total pain relief (TOTPAR) from 0 to 2, 4 and 12 hours post-dose
    Pain relief is measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total Pain Relief is calculated as the area under the curve of pain relief score over time for the given time period by multiplying the pain relief score at each time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. TOTPAR 0-2 ranges from 0 to 8, TOTPAR 0-4 ranges from 0 to 16, and TOTPAR 0-12 ranges from 0 to 48. A higher value indicates more pain relief
    date_rangeTime Frame:
    Up to 2 hours, 4 hours and 12 hours post dose
  • Time to first use of rescue medication
    date_rangeTime Frame:
    Up to 12 hours post dose
  • The cumulative percentage of participants taking rescue medication
    date_rangeTime Frame:
    Up to 12 hours post dose
  • Pain Intensity Difference (PID) at each evaluation
    Pain intensity is measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each post dose time point, pain intensity difference (PID) is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score – post-baseline score). A positive difference is indicative of improvement
    date_rangeTime Frame:
    Up to 12 hours post dose
  • Peak pain intensity difference (PID)
    Pain intensity is measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). Participants circle a number (from 0 to 10) on the Numerical Rating Scale to indicate the severity the pain they are experiencing at baseline and at each post dose time point. For each post dose time point, pain intensity difference (PID) is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score).
    date_rangeTime Frame:
    Up to 12 hours post dose
  • Pain relief score at each evaluation
    Pain relief is measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief)
    date_rangeTime Frame:
    Up to 12 hours post dose
  • Peak pain relief score
    Pain relief is measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). At each post-dose time point, participants check the appropriate box (from 0 to 4) on the Categorical Pain Relief Rating Scale to indicate the relief from starting pain at the post dose time points.
    date_rangeTime Frame:
    Up to 12 hours post dose
  • Global assessment of the investigational product
    Global assessment is performed either at 12 hours post-dose or immediately prior to the first intake of rescue medication. Global assessment is based on the question 'Overall, I would rate the study medication I received: 0=Poor, 1=Fair, 2=Good, 3=Very Good, 4=Excellent.'
    date_rangeTime Frame:
    Up to 12 hours post dose
  • Number of participants with adverse events
    date_rangeTime Frame:
    Up to 5 days post dose
  • The number of participants with clinically significant changes in physical examinations and vital signs
    date_rangeTime Frame:
    Up to 5 days post dose

Trial design

A Randomized, Double-Blind, Single-Dose, Parallel, Placebo-Controlled Trial to Determine the Dose of Caffeine in a Fixed Dose Combination Tablet of Naproxen Sodium and Caffeine to Effectively Alleviate Postsurgical Dental Pain
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
7