Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study

NCT03879408 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CCSPAA001068
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Keywords

Analgesics; Dental Pain; Naproxen; Acetaminophen; Pain

Outcome Measures

Primary Outcomes (2)

• Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 6 Hours (SPID 0-6)

  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-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 Outcomes (7)

• Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 6 Hours (TOTPAR 0-6)

  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)

  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)

  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)

  Baseline (0 hour) up to 8 hours post-dose

• Pain Relief (PAR) Scores at Individual Timepoints

  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

Study Arms (5)

440 mg naproxen sodium with 1000 mg acetaminophen

EXPERIMENTAL

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

Drug: 440 mg naproxen sodium with 1000 mg acetaminophen

220 mg naproxen sodium with 650 mg acetaminophen

EXPERIMENTAL

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

Drug: 220 mg naproxen sodium with 650 mg acetaminophen

10 mg hydrocodone + 650 mg acetaminophen

ACTIVE COMPARATOR

10 mg hydrocodone + 650 mg acetaminophen administered as a single dose of two hydrocodone 5 mg + acetaminophen 325 mg tablets and two placebo tablets

Drug: 10 mg hydrocodone + 650 mg acetaminophen

440 mg naproxen sodium

ACTIVE COMPARATOR

440 mg naproxen sodium administered as a single dose of two naproxen sodium 220 mg tablets and two placebo tablets

Drug: 440 mg naproxen sodium

Placebo tablet

PLACEBO COMPARATOR

Single dose of four placebo tablets

Drug: Placebo tablet

Interventions

440 mg naproxen sodium with 1000 mg acetaminophen DRUG

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

Also known as: Naproxen Sodium with Acetaminophen - High Dose

440 mg naproxen sodium with 1000 mg acetaminophen

220 mg naproxen sodium with 650 mg acetaminophen DRUG

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

Also known as: Naproxen Sodium with Acetaminophen - Low Dose

220 mg naproxen sodium with 650 mg acetaminophen

10 mg hydrocodone + 650 mg acetaminophen DRUG

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

Also known as: Commercial Hydrocodone + Acetaminophen Tablet

10 mg hydrocodone + 650 mg acetaminophen

440 mg naproxen sodium DRUG

440 mg naproxen sodium administered as a single dose of two naproxen sodium 220 mg tablets and two placebo tablets

Also known as: Naproxen sodium

440 mg naproxen sodium

Placebo tablet DRUG

Single dose of four placebo tablets

Placebo tablet

Eligibility Criteria

• Age: 17 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division: lead

Study Sites (1)

Jean Brown Research Clinical Research

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Pain; Toothache

Interventions

Naproxen; Acetaminophen; Hydrocodone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tooth Diseases; Stomatognathic Diseases; Facial Pain

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes

Results Point of Contact

• Title: ASSOCIATE DIRECTOR CLINICAL RESEARCH
• Organization: Johnson & Johnson Consumer, Inc.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Todd Bertoch, MD

  Jean Brown Research (JBR)

  PRINCIPAL INVESTIGATOR

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

Model Details: Post-operative dental pain following third molar extraction.

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 18, 2019
• Study Start: May 28, 2019
• Primary Completion: November 7, 2019
• Study Completion: November 13, 2019
• Last Updated: December 5, 2022
• Results First Posted: December 5, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)