check_circleStudy Completed

Dental Care, Pain

Bayer Identifier:

Trial_CC-01566

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
Naproxen Sodium, Extra-Strength Tylenol and Placebo in the treatment of pain secondary to Dental Impaction Surgery

Trial purpose

This was a single-dose, randomized, parallel, double-blind, singlecenter,
placebo and active treatment-controlled study designed for
225 subjects. Subjects were randomly assigned at a ratio of 2:2:1 to
receive two capsules of either naproxen sodium, acetaminophen, or
placebo. Subjects rated their pain intensity on categorical (CAT) and
visual analog scales (VAS). Pain relief was rated on categorical scales.
Pain intensity was evaluated immediately prior to study drug
administration. Pain intensity, pain relief, and "pain half gone" were
evaluated at 20, 30, 40, and 60 minutes and hourly thereafter for 12
hours following study drug administration.

Key Participants Requirements

Sex

All

Age

15 - 62 Years
  • - Healthy males and females atleast 15 years of age with at least
    moderate post operative pain associated with surgical removal of
    three or four third molars (including at least one mandibular partial or
    complete bony impaction) were enrolled in the study.

Trial summary

Enrollment Goal
223
Trial Dates
October 1992 - April 1993
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Aleve (Naproxen Sodium, BAY117031)
Accepts Healthy Volunteer
N/A

Primary Outcome

  • Time to take back up medication.
    To determine, if 440 mg of naproxen sodium has a longer duration of action than 1000 mg of Extra Strength Tylenol® in the treatment of pain secondary to dental impaction surgery.

Secondary Outcome

  • PID score
    20-minute pain intensity difference (PID) score based on categorical scale.
  • SPID scores
    Summed pain intensity difference (SPID) scores based on a categorical scale
    date_rangeTime Frame:
    at 4-, 6-, 8-, 10- and 12-hours
  • PID(VAS) score
    20-minute pain intensity difference (PID) score based on visual analog scale.
  • SPID(VAS) scores
    Summed pain intensity difference (SPID) scores based on a visual analog scale.
    date_rangeTime Frame:
    at 4-, 6-, 8-, 10- and 12-hours
  • Relief score
    20-minute pain relief score
  • TOTPAR (Total Pain Relief) scores
    date_rangeTime Frame:
    at 4-, 6-, 8-, 10- and 12-hours
  • The proportion of time points when the subject reported starting pain at least one-half gone
  • The time to onset of "some" relief, i.e., the first time the subject recorded at least 2 on a 5-point relief scale
  • The proportion of subjects taking backup medication or terminating early due to ineffectiveness of study medication

Trial design

Single-Dose Study Comparing the Safety, Efficacy and Duration of Naproxen Sodium, Extra-Strength Tylenol and Placebo in the treatment of pain secondary to Dental Impaction Surgery
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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