Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CCSPAA005199 | Other Grant/Funding Number | Johnson & Johnson Consumer, Inc. (JJCI) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This is a randomized, double-blind, placebo-controlled, single-dose full-factorial study to evaluate the analgesic efficacy and safety of a fixed combination of acetaminophen and naproxen sodium, compared with acetaminophen or naproxen sodium alone, and placebo following surgical extraction of three or four third molars.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetaminophen/Naproxen Sodium Fixed Combination | Experimental | Participants will receive a single oral dose of two Acetaminophen/Naproxen Sodium Fixed Combination tablets. |
|
| Naproxen Sodium | Active Comparator | Participants will receive a single oral dose of one Naproxen Sodium tablet with one Placebo capsule. |
|
| Acetaminophen | Active Comparator | Participants will receive a single oral dose of two Acetaminophen tablets. |
|
| Placebo | Placebo Comparator | Participants will receive a single oral dose of two Placebo capsules. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen/Naproxen Sodium Fixed Combination | Drug | Fixed combination of Acetaminophen/Naproxen Sodium will be administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time-weighted Sum of Pain Intensity Difference from 0 to 12 Hours After Dosing (SPID 0-12) | 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. | 0 to 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time-weighted Sum of Pain Intensity Difference From 6 to 12 Hours (SPID 6-12) | 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. | 6 to 12 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Todd Bertoch | JBR Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JBR Clinical Research LLC | Salt Lake City | Utah | 84107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24141714 | Background | 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. | |
| 14191090 | Background | 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. |
Not provided
Not provided
Johnson & Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
Not provided
Not provided
Not provided
Not provided
Post-operative dental pain following third molar extraction.
Not provided
Not provided
Not provided
| Naproxen Sodium | Drug | Naproxen Sodium will be administered orally. |
|
| Acetaminophen | Drug | Acetaminophen will be administered orally. |
|
| Placebo | Drug | Placebo will be administered orally. |
|
| Time to First Request of Rescue Analgesic |
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. |
| 0 to 24 hours |
| Percentage of Participants who Request Rescue Analgesic During the First 12 hours | Percentage of participants who request rescue analgesic during the first 12 hours will be reported. | 0 to 12 hours |
| 14248351 | Background | 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. |
| 16413237 | Background | 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. |
| 16580905 | Background | 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. |
| 18485596 | Background | 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. |
| 790189 | Background | Koch-Weser J. Drug therapy. Acetaminophen. N Engl J Med. 1976 Dec 2;295(23):1297-300. doi: 10.1056/NEJM197612022952306. No abstract available. |
| 6743 | Background | 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. |
| 329728 | Background | Ameer B, Greenblatt DJ. Acetaminophen. Ann Intern Med. 1977 Aug;87(2):202-9. doi: 10.7326/0003-4819-87-2-202. |
| Background | Product Monograph for Aleve (Naproxen Sodium Tablets USP/Liquid Gels/Capsules 220 mg). Bayer Inc. Consumer Care. Revised 8 January 2015 |
| 2202585 | Background | 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. |
| 9113437 | Background | Davies NM, Anderson KE. Clinical pharmacokinetics of naproxen. Clin Pharmacokinet. 1997 Apr;32(4):268-93. doi: 10.2165/00003088-199732040-00002. |
| 20336423 | Background | 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. |
| 26683233 | Background | 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. |
| 26997353 | Background | 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. |
| 18164917 | Background | 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. |
| 17933588 | Background | 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. |
| Background | 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. |
| Background | 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. |
| Background | 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. |
| Background | Little RJ, Rubin DB. Statistical analysis with missing data: John Wiley & Sons; 2002. |
| ID | Term |
|---|---|
| D010146 | Pain |
| D014098 | Toothache |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
Not provided
Not provided