Acetaminophen/Naproxen Sodium Dose Ranging Study
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Five Strengths of a Fixed Combination of Acetaminophen/Naproxen Sodium in Postoperative Dental Pain
1 other identifier
interventional
304
1 country
1
Brief Summary
Study assessing the relative efficacy of five strengths of a fixed combination of acetaminophen and naproxen sodium is being investigated to help inform selection of dose(s) for further development and to evaluate the safety of a fixed combination of naproxen sodium and acetaminophen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 pain
Started Nov 2020
Shorter than P25 for phase_2 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2020
CompletedFirst Posted
Study publicly available on registry
June 25, 2020
CompletedStudy Start
First participant enrolled
November 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 3, 2021
CompletedResults Posted
Study results publicly available
April 11, 2024
CompletedMarch 24, 2025
March 1, 2024
5 months
June 23, 2020
March 14, 2024
March 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 12 Hours (SPID 0-12)
Time weighted sum of the pain intensity difference (SPID) score is derived from pain intensity difference (PID) score. Pain intensity-numerical rating scale (PI-NRS) was used to assess pain intensity on scale ranged from 0 (no pain) to 10 (very severe pain), higher score indicated severe pain intensity. PID score was the difference between baseline pain intensity and pain intensity at assessment timepoint (12 hours). The SPID scores were derived by first multiplying each PID score by the time from the previous time point and adding these time weighted PID scores together over the interval from 0 to 12 hours. The possible range of SPID for 0 to 12 hours was from -120 to 120. A higher value of SPID indicated greater pain relief.
Baseline (0 hour) up to 12 hours post-dose on Day 1
Secondary Outcomes (4)
Time Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 12 Hours (TOTPAR 0-12)
Baseline (0 hour) up to 12 hours post-dose on Day 1
Time Weighted Sum of Pain Intensity Difference Score From 6 Hours to 12 Hours (SPID 6-12)
From 6 hours up to 12 hours post-dose on Day 1
Time to First Use of Rescue Analgesic Medication
From 0 minute up to 1440 minutes post-dose (that is, up to 24 hours post-dose) on Day 1
Proportion of Participants Who Required Rescue Analgesic Medication
From 0 hour up to 24 hours post-dose on Day 1
Study Arms (6)
Acetaminophen/naproxen sodium Dose A
EXPERIMENTALAcetaminophen/naproxen sodium Dose A administered as a single two-tablet dose.
Acetaminophen/naproxen sodium Dose B
EXPERIMENTALAcetaminophen/naproxen sodium Dose B administered as a single two-tablet dose.
Acetaminophen/naproxen sodium Dose C
EXPERIMENTALAcetaminophen/naproxen sodium Dose C administered as a single two-tablet dose.
Acetaminophen/naproxen sodium Dose D
EXPERIMENTALAcetaminophen/naproxen sodium Dose D administered as a single two-tablet dose.
Acetaminophen/naproxen sodium Dose E
EXPERIMENTALAcetaminophen/naproxen sodium Dose E administered as a single two-tablet dose.
Placebo
PLACEBO COMPARATORPlacebo tablets administered as a single two-tablet dose.
Interventions
Acetaminophen/naproxen sodium Dose A administered as a single two-tablet dose.
Acetaminophen/naproxen sodium Dose B administered as a single two-tablet dose.
Acetaminophen/naproxen sodium Dose C administered as a single two-tablet dose.
Acetaminophen/naproxen sodium Dose D administered as a single two-tablet dose.
Acetaminophen/naproxen sodium Dose E administered as a single two-tablet dose.
Eligibility Criteria
You may qualify if:
- Males or females 17-50 years old
- Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5-35.4 (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
You may not qualify if:
- 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 of any immunosuppressive drugs within 2 weeks of screening
- History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
JBR Clinical Research
Salt Lake City, Utah, 84107, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Assoc Dir Med Sci Leader US Self Care Pain
- Organization
- Johnson & Johnson Consumer, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Todd Bertoch, MD
JBR Clinical Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2020
First Posted
June 25, 2020
Study Start
November 9, 2020
Primary Completion
April 9, 2021
Study Completion
May 3, 2021
Last Updated
March 24, 2025
Results First Posted
April 11, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will share
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.