Clinical trial NCT04447040: Acetaminophen/Naproxen Sodium Dose Ranging Study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Five Strengths of a Fixed Combination of Acetaminophen/Naproxen Sodium in Postoperative Dental Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: Analgesics
Dental Pain
Acetaminophen
Naproxen Sodium
Pain
Fixed-Dose
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2020-06-25
Enrollment: 304
Sex: ALL
Minimum age (years): 17
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Post-operative dental pain following third molar extraction.
Primary purpose: TREATMENT

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.

Detailed description: This is a randomized, double-blind, placebo-controlled study to evaluate the analgesic efficacy and safety profile of the following doses of a fixed combination of Acetaminophen (APAP)/Naproxen sodium (NPX) administered as a single two-tablet dose:\[Acetaminophen/Naproxen Sodium Dose A, Acetaminophen/Naproxen Sodium Dose B, Acetaminophen/Naproxen Sodium Dose C, Acetaminophen/Naproxen Sodium Dose D, Acetaminophen/Naproxen Sodium Dose E and Placebo\] following surgical extraction of four third molars.

Eligibility criteria: Inclusion Criteria:

1. Males or females 17-50 years old
2. Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5-35.4 (inclusive) at screening
3. Surgical removal of three or four third molars, of which, two must be mandibular impactions
4. Meets requirements for post-surgical pain level
5. Females of childbearing potential and males agree to contraceptive requirements of study
6. Have a negative urine drug screen at screening, and on day of surgical procedure

Exclusion Criteria:

1. Pregnant female, breastfeeding, trying to become pregnant or male with pregnant partner or partner currently trying to become pregnant
2. Have a known allergy or hypersensitivity to naproxen or other NSAIDs, including aspirin, or to acetaminophen, oxycodone or other opioids;
3. Not able to swallow whole large tablets or capsules
4. History of any condition (s) in investigator's opinion, may jeopardize subject safety, well-being and integrity of study
5. Use analgesics 5 or more times per week
6. History of chronic tranquilizer use, heavy drinking, or substance abuse, as judged by the investigator site staff, in the last 5 years
7. Use of any immunosuppressive drugs within 2 weeks of screening
8. History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years

Primary outcomes:
measure: Time Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 12 Hours (SPID 0-12)
timeFrame: Baseline (0 hour) up to 12 hours post-dose on Day 1
Secondary outcomes:
measure: Time Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 12 Hours (TOTPAR 0-12)
timeFrame: Baseline (0 hour) up to 12 hours post-dose on Day 1
measure: Time Weighted Sum of Pain Intensity Difference Score From 6 Hours to 12 Hours (SPID 6-12)
timeFrame: From 6 hours up to 12 hours post-dose on Day 1
measure: Time to First Use of Rescue Analgesic Medication
timeFrame: From 0 minute up to 1440 minutes post-dose (that is, up to 24 hours post-dose) on Day 1
measure: Proportion of Participants Who Required Rescue Analgesic Medication
timeFrame: From 0 hour up to 24 hours post-dose on Day 1
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: JBR Clinical Research
state: Utah
Study officials:
affiliation: JBR Clinical Research
name: Todd Bertoch, MD
role: PRINCIPAL_INVESTIGATOR
References: