Acetaminophen/Naproxen Sodium Dose Ranging Study

McNeil-PPC

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Drug: Acetaminophen/naproxen sodium Dose E; Drug: Placebo; Drug: Acetaminophen/naproxen sodium Dose C; Drug: Acetaminophen/naproxen sodium Dose A; Drug: Acetaminophen/naproxen sodium Dose D; Drug: Acetaminophen/naproxen sodium Dose B

Study type: Interventional

Funder types: Industry

Identifiers

NCT04447040

CCSPAA002398

Details and patient eligibility

About

Study assessing the relative efficacy of five strengths of a fixed combination of acetaminophen and naproxen sodium is being investigated to help inform selection of dose(s) for further development and to evaluate the safety of a fixed combination of naproxen sodium and acetaminophen.

Full description

This is a randomized, double-blind, placebo-controlled study to evaluate the analgesic efficacy and safety profile of the following doses of a fixed combination of Acetaminophen (APAP)/Naproxen sodium (NPX) administered as a single two-tablet dose:[Acetaminophen/Naproxen Sodium Dose A, Acetaminophen/Naproxen Sodium Dose B, Acetaminophen/Naproxen Sodium Dose C, Acetaminophen/Naproxen Sodium Dose D, Acetaminophen/Naproxen Sodium Dose E and Placebo] following surgical extraction of four third molars.

Enrollment: 304 patients

Sex: All

Ages: 17 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males or females 17-50 years old
2. Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5-35.4 (inclusive) at screening
3. Surgical removal of three or 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 a known allergy or hypersensitivity to naproxen or other NSAIDs, including aspirin, or to acetaminophen, oxycodone or other opioids;
3. Not able to swallow whole 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, or substance abuse, as judged by the investigator site staff, in the last 5 years
7. Use of any immunosuppressive drugs within 2 weeks of screening
8. History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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304 participants in 6 patient groups, including a placebo group

Acetaminophen/naproxen sodium Dose A

Experimental group

Description:

Acetaminophen/naproxen sodium Dose A administered as a single two-tablet dose.

Treatment:

Drug: Acetaminophen/naproxen sodium Dose A

Acetaminophen/naproxen sodium Dose B

Experimental group

Description:

Acetaminophen/naproxen sodium Dose B administered as a single two-tablet dose.

Treatment:

Drug: Acetaminophen/naproxen sodium Dose B

Acetaminophen/naproxen sodium Dose C

Experimental group

Description:

Acetaminophen/naproxen sodium Dose C administered as a single two-tablet dose.

Treatment:

Drug: Acetaminophen/naproxen sodium Dose C

Acetaminophen/naproxen sodium Dose D

Experimental group

Description:

Acetaminophen/naproxen sodium Dose D administered as a single two-tablet dose.

Treatment:

Drug: Acetaminophen/naproxen sodium Dose D

Acetaminophen/naproxen sodium Dose E

Experimental group

Description:

Acetaminophen/naproxen sodium Dose E administered as a single two-tablet dose.

Treatment:

Drug: Acetaminophen/naproxen sodium Dose E

Placebo

Placebo Comparator group

Description:

Placebo tablets administered as a single two-tablet dose.

Treatment:

Drug: Placebo