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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test naproxen sodium tablet | Experimental | Single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets (Test NPX) |
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| Commercial naproxen sodium tablet | Active Comparator | Single dose of 440 mg of naproxen sodium administered as two commercial naproxen sodium 220 mg tablets |
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| 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 |
|
| Placebo tablet | Placebo Comparator | Single dose of two Placebo tablets |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test naproxen sodium tablet | Drug | Single dose of 2 test naproxen sodium 220 mg tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Todd M Bertoch, MD | JBR Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JBR Clinical Research | Salt Lake City | Utah | 84107 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Single dose of two Placebo tablets. |
| FG001 | Test Naproxen Sodium 440 Milligram (mg) | Single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets (Test NPX). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 19, 2018 | Mar 11, 2020 |
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Post-operative dental pain following third molar extraction.
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| Commercial naproxen sodium tablet | Drug | Single dose of 2 naproxen sodium 220 mg tablets |
|
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| Commercial naproxen sodium liquid gels capsule | Drug | Single dose of 2 naproxen sodium 220 mg liquid gel capsules |
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| Placebo tablet | Drug | 2 placebo tablets |
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| FG002 | Commercial Naproxen Sodium Tablet 440 mg | Single dose of 440 mg of naproxen sodium administered as two commercial naproxen sodium 220 mg tablets. |
| FG003 | Commercial Naproxen Sodium Liquid Gel Capsule 440 mg | Single dose of 440 mg of naproxen sodium administered as two 220 mg commercial liquid gels capsules. |
| COMPLETED |
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| NOT COMPLETED |
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Baseline characteristics were reported in all randomized participants who have received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Single dose of two Placebo tablets. |
| BG001 | Test Naproxen Sodium 440 Milligram (mg) | Single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets (Test NPX). |
| BG002 | Commercial Naproxen Sodium Tablet 440 mg | Single dose of 440 mg of naproxen sodium administered as two commercial naproxen sodium 220 mg tablets. |
| BG003 | Commercial Naproxen Sodium Liquid Gel Capsule 440 mg | Single dose of 440 mg of naproxen sodium administered as two 220 mg commercial liquid gels capsules. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Population analyzed included all randomized participants. | Posted | Median | Full Range | Minutes | 12 hours |
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| 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. | Population analyzed included all randomized participants. Data for this outcome measure was planned to be analyzed and reported only for Placebo and Test NPX (440 mg) arms. | Posted | Number | Percentage of Participants | Up to 45 minutes after dosing |
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Up to Day 70
The safety analysis dataset included all participants who took at least one dose of study medication and had any follow-up information.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Single dose of two Placebo tablets. | 0 | 58 | 0 | 58 | 6 | 58 |
| EG001 | Test Naproxen Sodium 440 Milligram (mg) | Single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets (Test NPX). | 0 | 152 | 0 | 152 | 2 | 152 |
| EG002 | Commercial Naproxen Sodium Tablet 440 mg | Single dose of 440 mg of naproxen sodium administered as two commercial naproxen sodium 220 mg tablets. | 0 | 142 | 0 | 142 | 6 | 142 |
| EG003 | Commercial Naproxen Sodium Liquid Gel Capsule 440 mg | Single dose of 440 mg of naproxen sodium administered as two 220 mg commercial liquid gels capsules. | 0 | 149 | 0 | 149 | 4 | 149 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 21.0 | Systematic Assessment |
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No study limitation was reported.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Sacavage, Associate Director Clinical Research | Johnson & Johnson Worldwide | 215-273-8568 | SSacavag@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 3, 2019 | Mar 11, 2020 | SAP_001.pdf |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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