check_circleStudy Completed

Pain

Study to collect information on how well the study drug Naproxen Sodium Tablets works compared to Hydrocodone/Acetaminophen Tablets in order to relieve pain in participants experiencing moderate to severe pain after having their wisdom teeth removed

Trial purpose

With this study researchers want to collect information on how long the pain relief lasts after a fixed dose of naproxen sodium or hydrocodone/acetaminophen or placebo (contains no medication) over 12 hours in subjects experiencing moderate to severe pain after having their wisdom teeth removed. Naproxen Sodium (Aleve®) is a drug that is used for the temporary relief of minor aches and pains.

Hydrocodone/Acetaminophen is a combination drug used to relieve moderate to severe pain. It contains an opioid (narcotic) pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).

Key Participants Requirements

Sex

All

Age

18 - 40 Years

Trial summary

Enrollment Goal
221
Trial Dates
March 2020 - October 2020
Phase
Phase 4
Could I Receive a placebo
Yes
Products
Aleve (Naproxen Sodium, BAY117031)
Accepts Healthy Volunteer
No

Where to participate

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

Primary Outcome

  • Sum of Pain Intensity Difference over 12 hours (SPID 0-12)
    Pain intensity is measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain).
    date_rangeTime Frame:
    Up to 12 hours postdose

Secondary Outcome

  • Total Pain Relief over 12 hours (TOTPAR 0-12)
    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 postdose
  • Total Pain Relief over 6 hours (TOTPAR 0-6)
    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 6 hours postdose
  • Sum of Pain Intensity Difference over 6 hours (SPID 0-6)
    Pain intensity is measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain).
    date_rangeTime Frame:
    Up to 6 hours postdose
  • Number of participants required or did not reqiure rescue pain medication
    date_rangeTime Frame:
    Up to 12 hours postdose
  • Amount of rescue medication
    date_rangeTime Frame:
    Up to 12 hours postdose
  • Time to first use of rescue medication
    date_rangeTime Frame:
    Up to 12 hours
  • Duration of Pain at Least Half Gone over 12 hours
    date_rangeTime Frame:
    Up to 12 hours
  • Duration of Pain at Least Half Gone over first 6 hours
    date_rangeTime Frame:
    Up to 6 hours postdose

Trial design

A Randomized, Double-Blind, Placebo-Controlled Trial to Compare the Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Hydrocodone/Acetaminophen Tablets in Postsurgical Dental Pain
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
3