A Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen and Naproxen Sodium in Postoperative Dental Pain

Back to results

Primary Purpose

Status

Recruiting

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Acetaminophen/Naproxen Sodium Fixed Combination

Naproxen Sodium

Acetaminophen

Placebo

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

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

Inclusion Criteria: Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5 to 30.4 (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 any immunosuppressive drugs within 2 weeks of surgical procedure History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years

Sites / Locations

JBR Clinical Research LLCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Acetaminophen/Naproxen Sodium Fixed Combination

Naproxen Sodium

Acetaminophen

Placebo

Arm Description

Participants will receive a single oral dose of two Acetaminophen/Naproxen Sodium Fixed Combination tablets.

Participants will receive a single oral dose of one Naproxen Sodium tablet with one Placebo capsule.

Participants will receive a single oral dose of two Acetaminophen tablets.

Participants will receive a single oral dose of two Placebo capsules.

Outcomes

Primary Outcome Measures

Time-weighted Sum of Pain Intensity Difference from 0 to 12 Hours After Dosing (SPID 0-12)

Time-weighted sum of pain intensity difference (SPID) scores will be calculated using values collected on the Pain Intensity-Numerical Rating Scale (PI-NRS) 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 Intensity Difference From 6 to 12 Hours (SPID 6-12)

Time-weighted sum of pain intensity difference (SPID) scores will be calculated using values collected on the PI-NRS ranging from 0-10 (0 = no pain, 10 = very severe pain) collected at each scheduled timepoint within the specified timeframe.

Time to First Request of Rescue Analgesic

Time to first request for rescue medication will be measured as the elapsed time from when investigational product (IP) was given until the time rescue medication was first requested.

Percentage of Participants who Request Rescue Analgesic During the First 12 hours

Percentage of participants who request rescue analgesic during the first 12 hours will be reported.

Full Information

NCT ID

NCT05761574

First Posted

February 27, 2023

Last Updated

October 10, 2023

Sponsor

Johnson & Johnson Consumer Inc. (J&JCI)

1. Study Identification

Unique Protocol Identification Number

NCT05761574

Brief Title

A Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen and Naproxen Sodium in Postoperative Dental Pain

Official Title

A Full-Factorial, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single-Dose Efficacy and Safety Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen, and Naproxen Sodium in Postoperative Dental Pain

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 22, 2023 (Actual)

Primary Completion Date

April 16, 2024 (Anticipated)

Study Completion Date

April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johnson & Johnson Consumer Inc. (J&JCI)

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

The purpose of this study is to evaluate how well a fixed combination of acetaminophen/naproxen sodium relieves postoperative dental pain compared with acetaminophen, naproxen sodium and placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Postoperative dental pain following third molar extraction.

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acetaminophen/Naproxen Sodium Fixed Combination

Arm Type

Experimental

Arm Description

Participants will receive a single oral dose of two Acetaminophen/Naproxen Sodium Fixed Combination tablets.

Arm Title

Naproxen Sodium

Arm Type

Active Comparator

Arm Description

Participants will receive a single oral dose of one Naproxen Sodium tablet with one Placebo capsule.

Arm Title

Acetaminophen

Arm Type

Active Comparator

Arm Description

Participants will receive a single oral dose of two Acetaminophen tablets.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants will receive a single oral dose of two Placebo capsules.

Intervention Type

Drug

Intervention Name(s)

Acetaminophen/Naproxen Sodium Fixed Combination

Intervention Description

Fixed combination of Acetaminophen/Naproxen Sodium will be administered orally.

Intervention Type

Drug

Intervention Name(s)

Naproxen Sodium

Intervention Description

Naproxen Sodium will be administered orally.

Intervention Type

Drug

Intervention Name(s)

Acetaminophen

Intervention Description

Acetaminophen will be administered orally.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo will be administered orally.

Primary Outcome Measure Information:

Title

Time-weighted Sum of Pain Intensity Difference from 0 to 12 Hours After Dosing (SPID 0-12)

Description

Time-weighted sum of pain intensity difference (SPID) scores will be calculated using values collected on the Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain) collected at each scheduled timepoint within the specified timeframe.

Time Frame

0 to 12 hours

Secondary Outcome Measure Information:

Title

Time-weighted Sum of Pain Intensity Difference From 6 to 12 Hours (SPID 6-12)

Description

Time-weighted sum of pain intensity difference (SPID) scores will be calculated using values collected on the PI-NRS ranging from 0-10 (0 = no pain, 10 = very severe pain) collected at each scheduled timepoint within the specified timeframe.

Time Frame

6 to 12 hours

Title

Time to First Request of Rescue Analgesic

Description

Time to first request for rescue medication will be measured as the elapsed time from when investigational product (IP) was given until the time rescue medication was first requested.

Time Frame

0 to 24 hours

Title

Percentage of Participants who Request Rescue Analgesic During the First 12 hours

Description

Percentage of participants who request rescue analgesic during the first 12 hours will be reported.

Time Frame

0 to 12 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5 to 30.4 (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 any immunosuppressive drugs within 2 weeks of surgical procedure History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kenvue GCO Clinical Mailbox

Phone

1-877-929-5131

Email

KenvueClinical_KV@kenvue.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Todd Bertoch

Organizational Affiliation

JBR Clinical Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

JBR Clinical Research LLC

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Individual Site Status

Recruiting

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

Citations:

PubMed Identifier

24141714

Citation

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Results Reference

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Citation

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Results Reference

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Pain

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial