Efficacy and Safety Study of a Test Naproxen Sodium 220mg Tablet in Postoperative Dental Pain

NCT03566979 | Completed Phase 3 Results FDA Drug

• 1 other identifier: CCSPAA000457
• Study Type: interventional
• Target: 501
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate analgesic onset, efficacy, and safety of a single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets compared with two commercial naproxen sodium products (two naproxen sodium 220 mg tablets and two naproxen sodium 220 mg liquid gels capsules) and placebo in the dental pain model following third-molar extractions.

Conditions

Post-operative Dental Pain

Outcome Measures

Primary Outcomes (1)

• Time to Confirmed Perceptible Pain Relief

  Minutes until confirmed first perceptible pain relief was achieved. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The first perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief.

  12 hours

Secondary Outcomes (1)

• Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments

  Up to 45 minutes after dosing

Study Arms (4)

Test naproxen sodium tablet

EXPERIMENTAL

Single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets (Test NPX)

Drug: Test naproxen sodium tablet

Commercial naproxen sodium tablet

ACTIVE COMPARATOR

Single dose of 440 mg of naproxen sodium administered as two commercial naproxen sodium 220 mg tablets

Drug: Commercial naproxen sodium tablet

Commercial naproxen sodium liquid gels capsule

ACTIVE COMPARATOR

Single dose of 440 mg of naproxen sodium administered as two 220 mg commercial liquid gels capsules

Drug: Commercial naproxen sodium liquid gels capsule

Placebo tablet

PLACEBO COMPARATOR

Single dose of two Placebo tablets

Drug: Placebo tablet

Interventions

Test naproxen sodium tablet DRUG

Single dose of 2 test naproxen sodium 220 mg tablets

Also known as: Test NPX tablet

Test naproxen sodium tablet

Commercial naproxen sodium tablet DRUG

Single dose of 2 naproxen sodium 220 mg tablets

Also known as: Commercial NPX tablet

Commercial naproxen sodium tablet

Commercial naproxen sodium liquid gels capsule DRUG

Single dose of 2 naproxen sodium 220 mg liquid gel capsules

Also known as: Commercial NPX liquid gels capsule

Commercial naproxen sodium liquid gels capsule

Placebo tablet DRUG

2 placebo tablets

Placebo tablet

Eligibility Criteria

• Age: 17 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years old
• Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5 to 30.4 (inclusive) at screening
• Dental extraction of three or four third molars
• Meets post-surgical pain
• 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

You may not qualify if:

• Pregnant female, breastfeeding, trying to be 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, hydrocodone or other opioids
• Not able to swallow 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, substance abuse as judged by investigator site staff within last 5 years
• Use of immunosuppressive drugs within 2 weeks of screening
• History of endoscopically documented peptic ulcer disease or bleeding disorder in last 2 years

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division: lead

Study Sites (1)

JBR Clinical Research

Salt Lake City, Utah, 84107, United States

Location

Limitations and Caveats

No study limitation was reported.

Results Point of Contact

• Title: Steven Sacavage, Associate Director Clinical Research
• Organization: Johnson & Johnson Worldwide

SSacavag@its.jnj.com

215-273-8568

Study Officials

• Todd M Bertoch, MD

  JBR Clinical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Post-operative dental pain following third molar extraction.

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: June 25, 2018
• Study Start: August 13, 2018
• Primary Completion: March 26, 2019
• Study Completion: April 15, 2019
• Last Updated: April 9, 2020
• Results First Posted: April 9, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)