A Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen and Naproxen Sodium in Postoperative Dental Pain
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate how well a fixed combination of acetaminophen/naproxen sodium relieves postoperative dental pain compared with acetaminophen, naproxen sodium and placebo.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Acetaminophen/Naproxen Sodium Fixed Combination Participants will receive a single oral dose of two Acetaminophen/Naproxen Sodium Fixed Combination tablets. |
Drug: Acetaminophen/Naproxen Sodium Fixed Combination
Fixed combination of Acetaminophen/Naproxen Sodium will be administered orally.
|
| Active Comparator: Naproxen Sodium Participants will receive a single oral dose of one Naproxen Sodium tablet with one Placebo capsule. |
Drug: Naproxen Sodium
Naproxen Sodium will be administered orally.
Drug: Placebo
Placebo will be administered orally.
|
| Active Comparator: Acetaminophen Participants will receive a single oral dose of two Acetaminophen tablets. |
Drug: Acetaminophen
Acetaminophen will be administered orally.
|
| Placebo Comparator: Placebo Participants will receive a single oral dose of two Placebo capsules. |
Drug: Placebo
Placebo will be administered orally.
|
Outcome Measures
Primary Outcome Measures
- Time-weighted Sum of Pain Intensity Difference from 0 to 12 Hours After Dosing (SPID 0-12) [0 to 12 hours]
Time-weighted sum of pain intensity difference (SPID) scores will be calculated using values collected on the Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain) collected at each scheduled timepoint within the specified timeframe.
Secondary Outcome Measures
- Time-weighted Sum of Pain Intensity Difference From 6 to 12 Hours (SPID 6-12) [6 to 12 hours]
Time-weighted sum of pain intensity difference (SPID) scores will be calculated using values collected on the PI-NRS ranging from 0-10 (0 = no pain, 10 = very severe pain) collected at each scheduled timepoint within the specified timeframe.
- Time to First Request of Rescue Analgesic [0 to 24 hours]
Time to first request for rescue medication will be measured as the elapsed time from when investigational product (IP) was given until the time rescue medication was first requested.
- Percentage of Participants who Request Rescue Analgesic During the First 12 hours [0 to 12 hours]
Percentage of participants who request rescue analgesic during the first 12 hours will be reported.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5 to 30.4 (inclusive) at screening
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Surgical removal of three or four third molars, of which, two must be mandibular impactions
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Meets requirements for post-surgical pain level
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Females of childbearing potential and males agree to contraceptive requirements of study
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Have a negative urine drug screen at screening, and on day of surgical procedure
Exclusion Criteria:
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Pregnant female, breastfeeding, trying to become pregnant or male with pregnant partner or partner currently trying to become pregnant
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Have a known allergy or hypersensitivity to naproxen (or other NSAIDs including aspirin) or to acetaminophen, oxycodone or other opioids
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Not able to swallow whole large tablets or capsules
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History of any condition(s) in investigator's opinion, may jeopardize subject safety, well-being and integrity of study
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Use analgesics 5 or more times per week
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History of chronic tranquilizer use, heavy drinking, or substance abuse, as judged by the investigator site staff, in the last 5 years
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Use any immunosuppressive drugs within 2 weeks of surgical procedure
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History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | JBR Clinical Research LLC | Salt Lake City | Utah | United States | 84107 |
Sponsors and Collaborators
- Johnson & Johnson Consumer Inc. (J&JCI)
Investigators
- Principal Investigator: Todd Bertoch, JBR Clinical Research
Study Documents (Full-Text)
None provided.More Information
Publications
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- 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.
- 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.
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- 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.
- 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.
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- 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.
- 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.
- 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.
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