A Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen and Naproxen Sodium in Postoperative Dental Pain
NCT ID: NCT05761574
Last Updated: 2025-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
447 participants
INTERVENTIONAL
2023-05-22
2024-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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Acetaminophen/Naproxen Sodium Fixed Combination
Participants will receive a single oral dose of two Acetaminophen/Naproxen Sodium Fixed Combination tablets.
Acetaminophen/Naproxen Sodium Fixed Combination
Fixed combination of Acetaminophen/Naproxen Sodium will be administered orally.
Naproxen Sodium
Participants will receive a single oral dose of one Naproxen Sodium tablet with one Placebo capsule.
Naproxen Sodium
Naproxen Sodium will be administered orally.
Placebo
Placebo will be administered orally.
Acetaminophen
Participants will receive a single oral dose of two Acetaminophen tablets.
Acetaminophen
Acetaminophen will be administered orally.
Placebo
Participants will receive a single oral dose of two Placebo capsules.
Placebo
Placebo will be administered orally.
Interventions
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Acetaminophen/Naproxen Sodium Fixed Combination
Fixed combination of Acetaminophen/Naproxen Sodium will be administered orally.
Naproxen Sodium
Naproxen Sodium will be administered orally.
Acetaminophen
Acetaminophen will be administered orally.
Placebo
Placebo will be administered orally.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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 any immunosuppressive drugs within 2 weeks of surgical procedure
* History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years
16 Years
50 Years
ALL
No
Sponsors
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Johnson & Johnson Consumer Inc. (J&JCI)
INDUSTRY
Responsible Party
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Principal Investigators
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Todd Bertoch
Role: PRINCIPAL_INVESTIGATOR
JBR Clinical Research
Locations
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JBR Clinical Research LLC
Salt Lake City, Utah, United States
Countries
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References
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World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
GUZMAN F, BRAUN C, LIM RK, POTTER GD, RODGERS DW. NARCOTIC AND NON-NARCOTIC ANALGESICS WHICH BLOCK VISCERAL PAIN EVOKED BY INTRA-ARTERIAL INJECTION OF BRADYKININ AND OTHER ALGESIC AGENTS. Arch Int Pharmacodyn Ther. 1964 Jun 1;149:571-88. No abstract available.
LIM RK, GUZMAN F, RODGERS DW, GOTO K, BRAUN C, DICKERSON GD, ENGLE RJ. SITE OF ACTION OF NARCOTIC AND NON-NARCOTIC ANALGESICS DETERMINED BY BLOCKING BRADYKININ-EVOKED VISCERAL PAIN. Arch Int Pharmacodyn Ther. 1964 Nov 1;152:25-58. No abstract available.
Aronoff DM, Oates JA, Boutaud O. New insights into the mechanism of action of acetaminophen: Its clinical pharmacologic characteristics reflect its inhibition of the two prostaglandin H2 synthases. Clin Pharmacol Ther. 2006 Jan;79(1):9-19. doi: 10.1016/j.clpt.2005.09.009. No abstract available.
Pickering G, Loriot MA, Libert F, Eschalier A, Beaune P, Dubray C. Analgesic effect of acetaminophen in humans: first evidence of a central serotonergic mechanism. Clin Pharmacol Ther. 2006 Apr;79(4):371-8. doi: 10.1016/j.clpt.2005.12.307.
Mallet C, Daulhac L, Bonnefont J, Ledent C, Etienne M, Chapuy E, Libert F, Eschalier A. Endocannabinoid and serotonergic systems are needed for acetaminophen-induced analgesia. Pain. 2008 Sep 30;139(1):190-200. doi: 10.1016/j.pain.2008.03.030. Epub 2008 May 15.
Koch-Weser J. Drug therapy. Acetaminophen. N Engl J Med. 1976 Dec 2;295(23):1297-300. doi: 10.1056/NEJM197612022952306. No abstract available.
Milton AS. Modern views on the pathogenesis of fever and the mode of action of antipyretic drugs. J Pharm Pharmacol. 1976 Apr;28(4 SUPPL):393-9. doi: 10.1111/j.2042-7158.1976.tb04186.x. No abstract available.
Ameer B, Greenblatt DJ. Acetaminophen. Ann Intern Med. 1977 Aug;87(2):202-9. doi: 10.7326/0003-4819-87-2-202.
Product Monograph for Aleve (Naproxen Sodium Tablets USP/Liquid Gels/Capsules 220 mg). Bayer Inc. Consumer Care. Revised 8 January 2015
Todd PA, Clissold SP. Naproxen. A reappraisal of its pharmacology, and therapeutic use in rheumatic diseases and pain states. Drugs. 1990 Jul;40(1):91-137. doi: 10.2165/00003495-199040010-00006.
Davies NM, Anderson KE. Clinical pharmacokinetics of naproxen. Clin Pharmacokinet. 1997 Apr;32(4):268-93. doi: 10.2165/00003088-199732040-00002.
Cooper SA, Desjardins PJ. The value of the dental impaction pain model in drug development. Methods Mol Biol. 2010;617:175-90. doi: 10.1007/978-1-60327-323-7_15.
Cooper SA, Desjardins PJ, Turk DC, Dworkin RH, Katz NP, Kehlet H, Ballantyne JC, Burke LB, Carragee E, Cowan P, Croll S, Dionne RA, Farrar JT, Gilron I, Gordon DB, Iyengar S, Jay GW, Kalso EA, Kerns RD, McDermott MP, Raja SN, Rappaport BA, Rauschkolb C, Royal MA, Segerdahl M, Stauffer JW, Todd KH, Vanhove GF, Wallace MS, West C, White RE, Wu C. Research design considerations for single-dose analgesic clinical trials in acute pain: IMMPACT recommendations. Pain. 2016 Feb;157(2):288-301. doi: 10.1097/j.pain.0000000000000375.
Lipkovich I, Ratitch B, O'Kelly M. Sensitivity to censored-at-random assumption in the analysis of time-to-event endpoints. Pharm Stat. 2016 May;15(3):216-29. doi: 10.1002/pst.1738. Epub 2016 Mar 21.
Cheung R, Krishnaswami S, Kowalski K. Analgesic efficacy of celecoxib in postoperative oral surgery pain: a single-dose, two-center, randomized, double-blind, active- and placebo-controlled study. Clin Ther. 2007;29 Suppl:2498-510. doi: 10.1016/j.clinthera.2007.12.008.
Fricke J, Davis N, Yu V, Krammer G. Lumiracoxib 400 mg compared with celecoxib 400 mg and placebo for treating pain following dental surgery: a randomized, controlled trial. J Pain. 2008 Jan;9(1):20-7. doi: 10.1016/j.jpain.2007.08.004. Epub 2007 Oct 15.
Clinical Study Report CCSPAA001068. A randomized, double-blind, placebo- and activecontrolled, proof of concept study to evaluate two strengths of concomitantly dosed naproxen sodium with acetaminophen, compared with naproxen sodium, hydrocodone/acetaminophen and placebo in postoperative dental pain.: Johnson & Johnson Consumer, Inc., May 2019.
Clinical Study Report CCSPAA002398. A Randomized, Double-blind, Placebo-controlled Study to Evaluate Five Strengths of a Fixed Combination of Acetaminophen/Naproxen Sodium in Postoperative Dental Pain.: Johnson & Johnson Consumer, Inc., November 2020.
21 CFR ยง 300.50 - Fixed-combination prescription drugs for humans, 40 FR 13496, Mar. 27, 1975, as amended at 64 FR 401, Jan. 5, 1999.
Little RJ, Rubin DB. Statistical analysis with missing data: John Wiley & Sons; 2002.
Other Identifiers
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CCSPAA005199
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CCSPAA005199
Identifier Type: -
Identifier Source: org_study_id
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