Trial Condition(s):
Dental Care, Pain
Ibuprofen, and placebo in the treatment of pain secondary to dental impaction surgery
Bayer Identifier:
Trial_CC-00594
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Inclusion Criteria
: - 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.
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status |
|---|
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
Primary Outcome
- Total pain relief (TOTPAR) scoresTimeframe: 6, 8, 10, and 12 hours
Secondary Outcome
- Summed pain intensity difference (SPID) scoresBased on a categorical scaleTimeframe: 6-, 8-, 10- and 12-hour
- The proportion of time points when the subject reported starting pain at least one-half goneTimeframe:
- Peak PID: maximum pain intensity difference (PID) scoreTimeframe:
- The proportion of subjects taking backup medicationTimeframe:
- The time interval between taking study medication and taking backup medicationTimeframe:
Additional Information
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