- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03879408
Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study
November 9, 2022 updated by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Randomized, Double-Blind, Placebo And Active Controlled, Study To Evaluate Two Strengths Of Concomitantly Dosed Naproxen Sodium With Acetaminophen, Compared With Naproxen Sodium and Hydrocodone/Acetaminophen In Postoperative Dental Pain
Study assessing efficacy and safety of concomitantly dosed naproxen sodium with acetaminophen, compared with naproxen sodium, hydrocodone/acetaminophen and Placebo in a postoperative dental pain.
Study Overview
Status
Completed
Conditions
Detailed Description
This is a randomized, double-blind, placebo- and active-controlled, parallel-group study to evaluate the analgesic efficacy and safety of concomitantly administered naproxen sodium 440 mg with acetaminophen 1000 mg and concomitantly administered naproxen sodium 220 mg with acetaminophen 650 mg, compared with a fixed combination of hydrocodone 10 mg/acetaminophen 650 mg, naproxen sodium 440 mg, and placebo over a twelve-hour period after surgical extraction of four third molars.
Study Type
Interventional
Enrollment (Actual)
290
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84107
- Jean Brown Research Clinical Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 50 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males of females 17-50 years old
- Weigh 100 pounds or greater and have a body mass index (BMI) of 18.5 to 35 (inclusive) at screening
- Surgical removal of up to 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 known allergy or hypersensitivity to naproxen or other NSAIDS, including aspirin, or to acetaminophen, tramadol, 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 peptic ulcer disease or gastrointestinal bleeding in the last two years or hematologic bleeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 440 mg naproxen sodium with 1000 mg acetaminophen
440 mg naproxen sodium with 1000 mg acetaminophen administered as a single dose of two naproxen sodium 220 mg tablets and two acetaminophen 500 mg tablets
|
440 mg naproxen sodium with 1000 mg acetaminophen administered as a single dose of two naproxen sodium 220 mg tablets and two acetaminophen 500 mg tablets
Other Names:
|
Experimental: 220 mg naproxen sodium with 650 mg acetaminophen
220 mg naproxen sodium with 650 mg acetaminophen administered as a single dose of one naproxen sodium 220 mg tablet and two acetaminophen 325 mg tablets and one placebo tablet
|
220 mg naproxen sodium with 650 mg acetaminophen administered as a single dose of one naproxen sodium 220 mg tablet and two acetaminophen 325 mg tablets and one placebo tablet
Other Names:
|
Active Comparator: 10 mg hydrocodone + 650 mg acetaminophen
10 mg hydrocodone + 650 mg acetaminophen administered as a single dose of two hydrocodone 5 mg + acetaminophen 325 mg tablets and two placebo tablets
|
10 mg hydrocodone with 650 mg acetaminophen administered as a single dose of two hydrocodone 5 mg + acetaminophen 325 mg tablets and two placebo tablets
Other Names:
|
Active Comparator: 440 mg naproxen sodium
440 mg naproxen sodium administered as a single dose of two naproxen sodium 220 mg tablets and two placebo tablets
|
440 mg naproxen sodium administered as a single dose of two naproxen sodium 220 mg tablets and two placebo tablets
Other Names:
|
Placebo Comparator: Placebo tablet
Single dose of four placebo tablets
|
Single dose of four placebo tablets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 6 Hours (SPID 0-6)
Time Frame: Baseline (0 hour) up to 6 hours post-dose
|
Time-weighted sum of the pain intensity difference (SPID) score was measured using a Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain).
The possible range of SPID for 0-6 hours was from -60 to 60.
A higher value of SPID indicated greater pain relief.
PID was the difference between baseline pain intensity and pain intensity at assessment.
Time-weighted sum of the pain intensity difference 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 intervals from 0 to 6 hours.
|
Baseline (0 hour) up to 6 hours post-dose
|
Time-weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 12 Hours (SPID 0-12)
Time Frame: Baseline (0 hour) up to 12 hours post-dose
|
Time-weighted sum of the pain intensity difference score was measured using a PI-NRS ranging from 0-10 (0 = no pain, 10 = very severe pain).
The possible range of SPID for 0-12 hours was from -120 to 120.
A higher value of SPID indicated greater pain relief.
PID was the difference between baseline pain intensity and pain intensity at assessment (12 hours).
Time-weighted sum of the pain intensity difference 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 intervals from 0 to 12 hours.
|
Baseline (0 hour) up to 12 hours post-dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 6 Hours (TOTPAR 0-6)
Time Frame: Baseline (0 hour) up to 6 hours post-dose
|
Time-weighted total pain relief (TOTPAR) was measured using a Pain Relief Numerical Rating Scale (PR-NRS) ranging from 0-10 (0 = no relief, 10 = complete relief).
Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.
The minimum value was 0, and the maximum value was 60.
Higher scores was indicative of more pain relief.
|
Baseline (0 hour) up to 6 hours post-dose
|
Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 8 Hours (TOTPAR 0-8)
Time Frame: Baseline (0 hour) up to 8 hours post-dose
|
TOTPAR was measured using a PR-NRS ranging from 0-10 (0 = no relief, 10 = complete relief).
Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.
The minimum value was 0, and the maximum value was 80. Higher scores was indicative of more pain relief.
|
Baseline (0 hour) up to 8 hours post-dose
|
Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 12 Hours (TOTPAR 0-12)
Time Frame: Baseline (0 hour) up to 12 hours post-dose
|
TOTPAR was measured using a PR-NRS ranging from 0-10 (0 = no relief, 10 = complete relief).
Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.
The minimum value was 0, and the maximum value was 120.
Higher scores was indicative of more pain relief.
|
Baseline (0 hour) up to 12 hours post-dose
|
Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 8 Hours (SPID 0-8)
Time Frame: Baseline (0 hour) up to 8 hours post-dose
|
Time-weighted sum of the pain intensity difference score was measured using a PI-NRS ranging from 0-10 (0 = no pain, 10 = very severe pain).
The possible range of SPID for 0-8 hours was from -80 to 80.
A higher value of SPID indicated greater pain relief.
PID was the difference between baseline pain intensity and pain intensity at assessment (8 hours).
Time-weighted sum of the pain intensity difference 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 intervals from 0 to 8 hours.
|
Baseline (0 hour) up to 8 hours post-dose
|
Pain Relief (PAR) Scores at Individual Timepoints
Time Frame: 0.25 hours, 0.5 hours, 0.75 hours, 1 hours, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, and 12 hours
|
Participants answered a question at individual time points: "how much relief do you have from your starting pain?" on a 11-point PR-NRS.
Scale ranged from 0=no relief to 10=complete relief.
Higher score indicated improvement in pain.
|
0.25 hours, 0.5 hours, 0.75 hours, 1 hours, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, and 12 hours
|
Pain Intensity Difference (PID) Scores at Individual Time Points
Time Frame: 0.25 hours, 0.5 hours, 0.75 hours, 1 hours, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, and 12 hours
|
Pain Intensity was self-reported over 12 hours, using a pain rating of 0-10 on the PI-NRS, with score ranged from 0-10 (0= no pain; 10 = worst imaginable pain).
Pain intensity differences were calculated with respect to baseline at each time point after study drug administration.
|
0.25 hours, 0.5 hours, 0.75 hours, 1 hours, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, and 12 hours
|
Participant's Global Evaluation of Study Medication OR Overall Impression of Study Medication According to Participant's Global Evaluation
Time Frame: Up to 12 hours
|
Participants were asked to rate their overall impression of the study medication using the following scale: poor (0), fair (1), good (2), very good (3), and excellent (4) where higher score represented better outcome.
|
Up to 12 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Todd Bertoch, MD, Jean Brown Research (JBR)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 28, 2019
Primary Completion (Actual)
November 7, 2019
Study Completion (Actual)
November 13, 2019
Study Registration Dates
First Submitted
March 1, 2019
First Submitted That Met QC Criteria
March 15, 2019
First Posted (Actual)
March 18, 2019
Study Record Updates
Last Update Posted (Actual)
December 5, 2022
Last Update Submitted That Met QC Criteria
November 9, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antipyretics
- Analgesics, Opioid
- Narcotics
- Respiratory System Agents
- Gout Suppressants
- Antitussive Agents
- Acetaminophen
- Naproxen
- Hydrocodone
- Acetaminophen, hydrocodone drug combination
Other Study ID Numbers
- CCSPAA001068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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