Trial Condition(s):
Dental Care, Pain
Naproxen Sodium, Extra-Strength Tylenol and Placebo in the treatment of pain secondary to Dental Impaction Surgery
Bayer Identifier:
Trial_CC-01566
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, 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.
Inclusion Criteria
: - 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.
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 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
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.Timeframe:
Secondary Outcome
- PID score20-minute pain intensity difference (PID) score based on categorical scale.Timeframe:
- SPID scoresSummed pain intensity difference (SPID) scores based on a categorical scaleTimeframe: at 4-, 6-, 8-, 10- and 12-hours
- PID(VAS) score20-minute pain intensity difference (PID) score based on visual analog scale.Timeframe:
- SPID(VAS) scoresSummed pain intensity difference (SPID) scores based on a visual analog scale.Timeframe: at 4-, 6-, 8-, 10- and 12-hours
- Relief score20-minute pain relief scoreTimeframe:
- TOTPAR (Total Pain Relief) scoresTimeframe: at 4-, 6-, 8-, 10- and 12-hours
- The proportion of time points when the subject reported starting pain at least one-half goneTimeframe:
- The time to onset of "some" relief, i.e., the first time the subject recorded at least 2 on a 5-point relief scaleTimeframe:
- The proportion of subjects taking backup medication or terminating early due to ineffectiveness of study medicationTimeframe:
Additional Information
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