Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study

PHASE2CompletedINTERVENTIONAL
Enrollment

290

Participants

Timeline

Start Date

May 28, 2019

Primary Completion Date

November 7, 2019

Study Completion Date

November 13, 2019

Conditions
Pain
Interventions
DRUG

440 mg naproxen sodium with 1000 mg acetaminophen

440 mg naproxen sodium with 1000 mg acetaminophen administered as a single dose of two naproxen sodium 220 mg tablets and two acetaminophen 500 mg tablets

DRUG

220 mg naproxen sodium with 650 mg acetaminophen

220 mg naproxen sodium with 650 mg acetaminophen administered as a single dose of one naproxen sodium 220 mg tablet and two acetaminophen 325 mg tablets and one placebo tablet

DRUG

10 mg hydrocodone + 650 mg acetaminophen

10 mg hydrocodone with 650 mg acetaminophen administered as a single dose of two hydrocodone 5 mg + acetaminophen 325 mg tablets and two placebo tablets

DRUG

440 mg naproxen sodium

440 mg naproxen sodium administered as a single dose of two naproxen sodium 220 mg tablets and two placebo tablets

DRUG

Placebo tablet

Single dose of four placebo tablets

Trial Locations (1)

84107

Jean Brown Research Clinical Research, Salt Lake City

All Listed Sponsors
lead

Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

INDUSTRY

NCT03879408 - Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study | Biotech Hunter | Biotech Hunter