stop_circleTerminated/Withdrawn

Dental Care, Pain

Bayer Identifier:

Trial_CC-00594

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

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

Trial purpose

This was a single-dose, randomized, parallel, double-blind design
requiring 175 evaluable subjects at a single center. Subjects were
randomly assigned to one of the 3 groups in 2:2:1 ratio to receive a
single dose of naproxen (187.5 mg), ibuprofen (200 mg), or placebo.
After dosing with study medication, the subjects had to remain at the
study site for 2 hours. Analgesic response was evaluated on
categorical scales by subjects’ ratings of their pain intensity and pain
relief. Pain intensity was evaluated immediately prior to study drug
administration, and both pain intensity and pain relief were evaluated
hourly thereafter for 12 hours following study drug administration.

Key Participants Requirements

Sex

All

Age

17 - 43 Years
  • - Generally healthy subjects, at least 15 years of age, with at least
    moderate pain following surgical extraction of one or 2 third molars
    with at least one being a mandibular partial or complete bony
    impaction were enrolled in the study.

Trial summary

Enrollment Goal
12
Trial Dates
June 1992 - July 1992
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Aleve (Naproxen Sodium, BAY117031)
Accepts Healthy Volunteer
N/A

Primary Outcome

  • Total pain relief (TOTPAR) scores
    date_rangeTime Frame:
    6, 8, 10, and 12 hours

Secondary Outcome

  • Summed pain intensity difference (SPID) scores
    Based on a categorical scale
    date_rangeTime Frame:
    6-, 8-, 10- and 12-hour
  • The proportion of time points when the subject reported starting pain at least one-half gone
  • Peak PID: maximum pain intensity difference (PID) score
  • 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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