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Acetaminophen/Naproxen Sodium Fixed Combination in Postoperative Dental Pain
NCT05761574Phase 3
Key facts
- Status
- Completed
- Start
- May 2023
- Primary completion
- May 2024
- Countries
- 1
- Sponsor
- Johnson & Johnson
- Modality
- Small Molecules
- Drugs
- acetaminophenAprol
- Conditions
- odontalgia
01
Overview
Phase 3, randomised, double-blind trial of acetaminophen and Aprol in odontalgia (4 arms), sponsored by Johnson & Johnson. Primary endpoint: Time-weighted Sum of Pain Intensity Difference From 0 to 12 Hours After Dosing. Started May 2023; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Acetaminophen/Naproxen Sodium Fixed Combination
Single oral dose of two Acetaminophen/Naproxen Sodium Fixed Combination tablets
Naproxen Sodium
Single oral dose of one Naproxen Sodium tablet with one Placebo capsule
Acetaminophen
Single oral dose of two Acetaminophen tablets
Placebo
Single oral dose of two Placebo capsules
03
Who it enrols
Participants must weigh at least 100 pounds, have a BMI of 17.5 to 30.4, and require surgical removal of three or four third molars (including two mandibular impactions). Pregnant or breastfeeding females, individuals with a history of substance abuse, and those with known allergies to NSAIDs or acetaminophen are excluded.
04
Endpoints
Primary
Time-weighted Sum of Pain Intensity Difference From 0 to 12 Hours After Dosing
Secondary
Time-weighted Sum of Pain Intensity Difference From 6 to 12 Hours
Time to First Request of Rescue Analgesic
Proportion of Subjects Who Request Rescue Analgesic During the First 12 Hours
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