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

Primary Purpose

Post-operative Dental Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Test naproxen sodium tablet
Commercial naproxen sodium tablet
Commercial naproxen sodium liquid gels capsule
Placebo tablet
Sponsored by
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Dental Pain

Eligibility Criteria

17 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • JBR Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Test naproxen sodium tablet

Commercial naproxen sodium tablet

Commercial naproxen sodium liquid gels capsule

Placebo tablet

Arm Description

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

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

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

Single dose of two Placebo tablets

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 12, 2018
Last Updated
April 8, 2020
Sponsor
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
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1. Study Identification

Unique Protocol Identification Number
NCT03566979
Brief Title
Efficacy and Safety Study of a Test Naproxen Sodium 220mg Tablet in Postoperative Dental Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 13, 2018 (Actual)
Primary Completion Date
March 26, 2019 (Actual)
Study Completion Date
April 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Dental Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Post-operative dental pain following third molar extraction.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
501 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test naproxen sodium tablet
Arm Type
Experimental
Arm Description
Single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets (Test NPX)
Arm Title
Commercial naproxen sodium tablet
Arm Type
Active Comparator
Arm Description
Single dose of 440 mg of naproxen sodium administered as two commercial naproxen sodium 220 mg tablets
Arm Title
Commercial naproxen sodium liquid gels capsule
Arm Type
Active Comparator
Arm Description
Single dose of 440 mg of naproxen sodium administered as two 220 mg commercial liquid gels capsules
Arm Title
Placebo tablet
Arm Type
Placebo Comparator
Arm Description
Single dose of two Placebo tablets
Intervention Type
Drug
Intervention Name(s)
Test naproxen sodium tablet
Other Intervention Name(s)
Test NPX tablet
Intervention Description
Single dose of 2 test naproxen sodium 220 mg tablets
Intervention Type
Drug
Intervention Name(s)
Commercial naproxen sodium tablet
Other Intervention Name(s)
Commercial NPX tablet
Intervention Description
Single dose of 2 naproxen sodium 220 mg tablets
Intervention Type
Drug
Intervention Name(s)
Commercial naproxen sodium liquid gels capsule
Other Intervention Name(s)
Commercial NPX liquid gels capsule
Intervention Description
Single dose of 2 naproxen sodium 220 mg liquid gel capsules
Intervention Type
Drug
Intervention Name(s)
Placebo tablet
Intervention Description
2 placebo tablets
Primary Outcome Measure Information:
Title
Time to Confirmed Perceptible Pain Relief
Description
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.
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
Description
Percentage of participants with confirmed perceptible pain relief from 45 minutes to successively earlier minutes in one-minute increments were reported.
Time Frame
Up to 45 minutes after dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 17 - 50 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd M Bertoch, MD
Organizational Affiliation
JBR Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
JBR Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Johnson & Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
IPD Sharing URL
http://yoda.yale.edu.

Learn more about this trial

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

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