Status:
COMPLETED
Acetaminophen/Naproxen Sodium Dose Ranging Study
Lead Sponsor:
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Conditions:
Pain
Eligibility:
All Genders
17-50 years
Phase:
PHASE2
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 an...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2021
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT04447040
Start Date
November 9 2020
End Date
May 3 2021
Last Update
March 24 2025
Active Locations (1)
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1
JBR Clinical Research
Salt Lake City, Utah, United States, 84107