check_circleStudy Completed

Dental Care, Pain

Bayer Identifier:

Trial_CC-01550

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
Naproxen, ibuprofen and placebo in the treatment of pain secondary to dental impaction surgery

Trial purpose

This single center, single-dose randomized, double-blind, parallel,
placebo- and active- controlled study was designed for 175 evaluable
subjects. Subjects were randomly assigned to one of the 3 treatment
groups in the ratio of 2:2:1 (naproxen 187.5 mg [NAP187.5] or
ibuprofen 200 mg [IBU200] or placebo). Pain response was evaluated
immediately prior to administration of study drug, 1 hour and hourly
thereafter up to 12 hours. Pain intensity and pain relief were
measured on categorical scales and subjects were asked if their pain
was at least half gone from baseline at each time point. Subjects
remained in the study for up to 12 hours. Back up analgesic
medications was available for those subjects who experienced
insufficient pain relief from the study medication.

Key Participants Requirements

Sex

N/A

Age

15 Years
  • - Healthy subjects > 15 years of age who experienced at least moderate
    pain following the surgical extraction of one or two third molars (at
    least one must be a mandibular partial bony or complete bony
    impaction).

Trial summary

Enrollment Goal
175
Trial Dates
June 1992 - July 1992
Phase
Phase 4
Could I Receive a placebo
Yes
Products
Aleve (Naproxen Sodium, BAY117031)
Accepts Healthy Volunteer
N/A

Primary Outcome

  • Computing the total pain relief (TOTPAR) scores for each subject
    date_rangeTime Frame:
    at 6, 8, 10 and 12 hours

Secondary Outcome

  • Summed pain intensity difference (SPID) scores
    Based on a categorical scale
    date_rangeTime Frame:
    at 6, 8, 10 and 12 hours
  • The proportion of time points when the subject reported starting pain at least one-half gone
  • Peak PID: maximum pain intensity difference (PID) score
  • Peak relief: maximum pain relief score
  • The time to onset of pain relief
    Time interval between taking study medication and onset of at least "some" pain relief (as indicated by a score of at least 2 on a 5-point scale)
  • The proportion of subjects taking backup medication
  • The time interval between taking study medication and taking backup medication

Trial design

Single-dose efficacy comparison of naproxen, ibuprofen 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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