Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study

McNeil-PPC

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Drug: 440 mg naproxen sodium; Drug: 220 mg naproxen sodium with 650 mg acetaminophen; Drug: 10 mg hydrocodone + 650 mg acetaminophen; Drug: 440 mg naproxen sodium with 1000 mg acetaminophen; Drug: Placebo tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT03879408

CCSPAA001068

Details and patient eligibility

About

Study assessing efficacy and safety of concomitantly dosed naproxen sodium with acetaminophen, compared with naproxen sodium, hydrocodone/acetaminophen and Placebo in a postoperative dental pain.

Full description

This is a randomized, double-blind, placebo- and active-controlled, parallel-group study to evaluate the analgesic efficacy and safety of concomitantly administered naproxen sodium 440 mg with acetaminophen 1000 mg and concomitantly administered naproxen sodium 220 mg with acetaminophen 650 mg, compared with a fixed combination of hydrocodone 10 mg/acetaminophen 650 mg, naproxen sodium 440 mg, and placebo over a twelve-hour period after surgical extraction of four third molars.

Enrollment: 290 patients

Sex: All

Ages: 17 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males of females 17-50 years old
2. Weigh 100 pounds or greater and have a body mass index (BMI) of 18.5 to 35 (inclusive) at screening
3. Surgical removal of up to four third molars, of which, two must be mandibular impactions
4. Meets requirements for post -surgical pain level
5. Females of childbearing potential and males agree to contraceptive requirements of study
6. Have a negative urine drug screen at screening, and on day of surgical procedure

Exclusion criteria

1. Pregnant female, breastfeeding, trying to become pregnant or male with pregnant partner or partner currently trying to become pregnant
2. Have known allergy or hypersensitivity to naproxen or other NSAIDS, including aspirin, or to acetaminophen, tramadol, hydrocodone or other opioids
3. Not able to swallow large tablets or capsules
4. History of any condition (s) in investigator's opinion, may jeopardize subject safety, well-being and integrity of study
5. Use analgesics 5 or more times per week
6. History of chronic tranquilizer use, heavy drinking, substance abuse as judged by investigator site staff within last 5 years
7. Use of immunosuppressive drugs within 2 weeks of screening
8. History of peptic ulcer disease or gastrointestinal bleeding in the last two years or hematologic bleeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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290 participants in 5 patient groups, including a placebo group

440 mg naproxen sodium with 1000 mg acetaminophen

Experimental group

Description:

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

Treatment:

Drug: 440 mg naproxen sodium with 1000 mg acetaminophen

220 mg naproxen sodium with 650 mg acetaminophen

Experimental group

Description:

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

Treatment:

Drug: 220 mg naproxen sodium with 650 mg acetaminophen

10 mg hydrocodone + 650 mg acetaminophen

Active Comparator group

Description:

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

Treatment:

Drug: 10 mg hydrocodone + 650 mg acetaminophen

440 mg naproxen sodium

Active Comparator group

Description:

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

Treatment:

Drug: 440 mg naproxen sodium

Placebo tablet

Placebo Comparator group

Description:

Single dose of four placebo tablets

Treatment:

Drug: Placebo tablet