Acetaminophen/Naproxen Sodium Dose Ranging Study

Sponsor

Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (Industry)

Overall Status

Completed

CT.gov ID

NCT04447040

Collaborator

(none)

304

Enrollment

Location

Arms

5.7

Actual Duration (Months)

52.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: Acetaminophen/naproxen sodium Dose A Drug: Acetaminophen/naproxen sodium Dose B Drug: Acetaminophen/naproxen sodium Dose C Drug: Acetaminophen/naproxen sodium Dose D Drug: Acetaminophen/naproxen sodium Dose E Drug: Placebo	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

304 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Post-operative dental pain following third molar extraction.Post-operative dental pain following third molar extraction.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Five Strengths of a Fixed Combination of Acetaminophen/Naproxen Sodium in Postoperative Dental Pain

Actual Study Start Date :

Nov 9, 2020

Actual Primary Completion Date :

Apr 9, 2021

Actual Study Completion Date :

May 3, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acetaminophen/naproxen sodium Dose A Acetaminophen/naproxen sodium Dose A administered as a single two-tablet dose.	Drug: Acetaminophen/naproxen sodium Dose A Acetaminophen/naproxen sodium Dose A administered as a single two-tablet dose.
Experimental: Acetaminophen/naproxen sodium Dose B Acetaminophen/naproxen sodium Dose B administered as a single two-tablet dose.	Drug: Acetaminophen/naproxen sodium Dose B Acetaminophen/naproxen sodium Dose B administered as a single two-tablet dose.
Experimental: Acetaminophen/naproxen sodium Dose C Acetaminophen/naproxen sodium Dose C administered as a single two-tablet dose.	Drug: Acetaminophen/naproxen sodium Dose C Acetaminophen/naproxen sodium Dose C administered as a single two-tablet dose.
Experimental: Acetaminophen/naproxen sodium Dose D Acetaminophen/naproxen sodium Dose D administered as a single two-tablet dose.	Drug: Acetaminophen/naproxen sodium Dose D Acetaminophen/naproxen sodium Dose D administered as a single two-tablet dose.
Experimental: Acetaminophen/naproxen sodium Dose E Acetaminophen/naproxen sodium Dose E administered as a single two-tablet dose.	Drug: Acetaminophen/naproxen sodium Dose E Acetaminophen/naproxen sodium Dose E administered as a single two-tablet dose.
Placebo Comparator: Placebo Placebo tablets administered as a single two-tablet dose.	Drug: Placebo Placebo tablets administered as a single two-tablet dose.

Outcome Measures

Primary Outcome Measures

Time Weighted Sum of Pain Intensity Difference from 0 to 12 hours after dosing (SPID 0-12) [0 to 12 hours]
Time-weighted sum of the pain intensity difference scores (SPID) will be calculated using values collected on the pain intensity Numerical Rating Scale ranging from 0-10 (0 = no pain, 10 = very severe pain) collected at each scheduled timepoint within the specified timeframe.

Secondary Outcome Measures

Time Weighted Sum of Pain Relief from 0 to 12 hours (TOTPAR 0-12) [0 to 12 hours]
Time-weighted sum of the pain relief scores (TOTPAR) will be calculated using values collected on the pain relief Numerical Rating Scale ranging from 0-10 (0= no relief, 10= complete relief) collected at each scheduled timepoint within the specified timeframe.
Time weighted sum of pain intensity difference from 6 to 12 hours (SPID 6-12) [6 to 12 hours]
Time-weighted sum of the pain intensity difference scores (SPID) will be calculated using values collected on the pain intensity Numerical Rating Scale ranging from 0-10 (0 = no pain, 10 = very severe pain) collected at each scheduled timepoint within the specified timeframe.
Time to first use of rescue analgesic [0 to 24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Males or females 17-50 years old
Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5-35.4 (inclusive) at screening
Surgical removal of three or four third molars, of which, two must be mandibular impactions
Meets requirements for post-surgical pain level
Females of childbearing potential and males agree to contraceptive requirements of study
Have a negative urine drug screen at screening, and on day of surgical procedure

Exclusion Criteria:

Pregnant female, breastfeeding, trying to become pregnant or male with pregnant partner or partner currently trying to become pregnant
Have a known allergy or hypersensitivity to naproxen or other NSAIDs, including aspirin, or to acetaminophen, oxycodone or other opioids;
Not able to swallow whole large tablets or capsules
History of any condition (s) in investigator's opinion, may jeopardize subject safety, well-being and integrity of study
Use analgesics 5 or more times per week
History of chronic tranquilizer use, heavy drinking, or substance abuse, as judged by the investigator site staff, in the last 5 years
Use of any immunosuppressive drugs within 2 weeks of screening
History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years