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Safety of Acetaminophen/Naproxen Sodium in Adolescents with Orthodontic Pain
NCT05845008Phase 3
Key facts
- Status
- Withdrawn
- Start
- Jan 2024
- Primary completion
- Jul 2024
- Countries
- 1
- Sponsor
- Johnson & Johnson
- Modality
- Small Molecules
- Drugs
- acetaminophenAprol
- Conditions
- orthodontic pain
01
Overview
Phase 3, open-label, single-arm trial of acetaminophen and Aprol in orthodontic pain, sponsored by Johnson & Johnson. Primary endpoints: Number of Participants with Treatment-emergent Adverse Events, Number of Participants with Serious Adverse Events and 1 more. Planned start Jan 2024; status: withdrawn.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Acetaminophen/Naproxen Sodium Fixed Combination
Participants self-administer fixed combination orally.
03
Who it enrols
Adolescents 12 to <17 years old weighing >=72 lbs with post-procedure orthodontic pain, excluding those with motion sickness, routine analgesic use, or gastrointestinal/bleeding disorders.
04
Endpoints
Primary
Number of Participants with Treatment-emergent Adverse Events
Number of Participants with Serious Adverse Events
Number of Participants with Treatment-related Adverse Events
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