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

Post-operative Dental Pain Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo- and Active- Controlled, Efficacy and Safety Study of a Test Naproxen Sodium 220 mg Tablet in Postoperative Dental Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03566979
• Other study ID #: CCSPAA000457
• Status: Completed
• Phase: Phase 3
• Start date: August 13, 2018
• Est. completion date: April 15, 2019

Study information

• Verified date: April 2020
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a single-dose, randomized, double-blind, placebo- and active- controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of 440 mg of naproxen sodium administered as two Test NPX 220 mg tablets compared with two commercial products and placebo over a twelve-hour period after third-molar extractions. Subjects will undergo dental extraction of three or four third molars.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: April 15, 2019
• Est. primary completion date: March 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 50 Years

Eligibility

Inclusion Criteria:

1. 17 - 50 years old

2. Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5 to 30.4 (inclusive) at screening

3. Dental extraction of three or four third molars

4. Meets post-surgical pain

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 be 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, 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 endoscopically documented peptic ulcer disease or bleeding disorder in last 2 years

Related Conditions & MeSH terms

• Post-operative Dental Pain
• Toothache

Intervention

Drug:
• Test naproxen sodium tablet
Single dose of 2 test naproxen sodium 220 mg tablets
• Commercial naproxen sodium tablet
Single dose of 2 naproxen sodium 220 mg tablets
• Commercial naproxen sodium liquid gels capsule
Single dose of 2 naproxen sodium 220 mg liquid gel capsules
• Placebo tablet
2 placebo tablets

Locations

Country	Name	City	State
United States	JBR Clinical Research	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments	Percentage of participants with confirmed perceptible pain relief from 45 minutes to successively earlier minutes in one-minute increments were reported.	Up to 45 minutes after dosing