A Study of Acetaminophen/Naproxen Sodium Fixed Combination Tablets in Adolescents 12 to <17 Years of Age With Pain
NCT ID: NCT05844995
Last Updated: 2024-03-15
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE1
Total Enrollment
24 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-09-13
Study Completion Date
2024-02-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The purpose of this study is to investigate the population pharmacokinetics of acetaminophen and naproxen from a novel acetaminophen /naproxen sodium fixed combination tablet in adolescents 12 to less than (\<) 17 years of age with post-procedure orthodontic pain and to describe the effect of subject-specific covariates, including age and body weight, on inter-subject variability in acetaminophen and naproxen pharmacokinetics in adolescents 12 to \<17 years of age with post-procedure orthodontic pain.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Multiple-Dose Safety Study of Fixed Combination of Acetaminophen/Naproxen Sodium in Adolescents With Orthodontic Pain
NCT05845008
Orthodontic Pain
WITHDRAWN
PHASE3
A Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen and Naproxen Sodium in Postoperative Dental Pain
NCT05761574
Pain
COMPLETED
PHASE3
Acetaminophen/Naproxen Sodium Dose Ranging Study
NCT04447040
Pain
COMPLETED
PHASE2
Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study
NCT03879408
Pain
COMPLETED
PHASE2
Pre-emptive Analgesics in Orthodontic Treatment
NCT03523988
NSAID
Pain Management
COMPLETED
PHASE4
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Orthodontic Pain
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Acetaminophen /Naproxen Sodium
Participants with age group 12 to less than (\<) 17 years who undergone a non-surgical orthodontic procedure will enroll and receive fixed dose combination of acetaminophen/naproxen sodium tablet orally on baseline (Day 0).
Group Type
EXPERIMENTAL
Acetaminophen/Naproxen Sodium
Intervention Type
DRUG
Fixed dose combination of acetaminophen/naproxen sodium tablet will be administered orally.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Acetaminophen/Naproxen Sodium
Fixed dose combination of acetaminophen/naproxen sodium tablet will be administered orally.
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* A parent or a legal guardian of the participant has signed and dated the informed consent document and a written assent has been signed by the participant
* Has undergone an orthodontic procedure within 72 hours prior to dosing
* Is otherwise a healthy adolescent between the ages of 12 to less than (\<) 17 years at baseline (dosing). Health is defined as the absence of clinically relevant abnormalities as judged by the principle investigator (PI) on the basis of a detailed medical history, physical examination, blood pressure, respiratory rate and pulse rate measurements, and clinical laboratory tests. The responsible PI may request additional investigations or analyses if necessary
* Has a minimum weight of 72 pounds and has a Body Mass Index (BMI) between the 5th and 95th percentile for their age at dosing
* Has been fasted for at least 10 hours prior to dose administration of the investigational product
* Is a non-tobacco user or previous user who completely stopped smoking or using any form of tobacco or nicotine-containing product \[including e-cigarettes, cigarettes, non-combusted cigarettes, cigars, smokeless tobacco (such as dip, snuff, snus, and chewing tobacco)\] for at least 12 months before screening visit of this study
* If female, have a negative test for pregnancy at screening and baseline (dosing)
* Females of childbearing potential and males agree to the contraceptive requirements
* Is able to comprehend the requirements of the study (based upon clinical site personnel's assessment) and is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified within the protocol
* Are willing for investigational product of this study to be the only analgesic product used during the study
* Is related to persons involved directly or indirectly with the conduct of the study (that is, principal investigator, sub-investigators, study coordinators, other study personnel, employees or contractors of the Sponsor or Johnson \& Johnson (J\&J) subsidiaries, and the family of each)
* Has undergone an orthodontic procedure within 72 hours prior to dosing
* Is otherwise a healthy adolescent between the ages of 12 to less than (\<) 17 years at baseline (dosing). Health is defined as the absence of clinically relevant abnormalities as judged by the principle investigator (PI) on the basis of a detailed medical history, physical examination, blood pressure, respiratory rate and pulse rate measurements, and clinical laboratory tests. The responsible PI may request additional investigations or analyses if necessary
* Has a minimum weight of 72 pounds and has a Body Mass Index (BMI) between the 5th and 95th percentile for their age at dosing
* Has been fasted for at least 10 hours prior to dose administration of the investigational product
* Is a non-tobacco user or previous user who completely stopped smoking or using any form of tobacco or nicotine-containing product \[including e-cigarettes, cigarettes, non-combusted cigarettes, cigars, smokeless tobacco (such as dip, snuff, snus, and chewing tobacco)\] for at least 12 months before screening visit of this study
* If female, have a negative test for pregnancy at screening and baseline (dosing)
* Females of childbearing potential and males agree to the contraceptive requirements
* Is able to comprehend the requirements of the study (based upon clinical site personnel's assessment) and is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified within the protocol
* Are willing for investigational product of this study to be the only analgesic product used during the study
* Is related to persons involved directly or indirectly with the conduct of the study (that is, principal investigator, sub-investigators, study coordinators, other study personnel, employees or contractors of the Sponsor or Johnson \& Johnson (J\&J) subsidiaries, and the family of each)
Exclusion Criteria
* Use of prescription or non-prescription medications within a period less than 5 half-lives before the first investigational product (IP) administration unless these are contraceptives or occasional use of other medications approved by the Investigator
* Use of Ibuprofen within 6 hours prior to the dose administration of the investigational product
* Use of any vitamins, dietary and herbal supplements within seven days before first dose of study drug
* Has hypersensitivity to acetaminophen, naproxen, other non-steroidal anti-inflammatory drug (NSAIDs), including acetylsalicylic acid, or to any of the ingredients
* If female, has a positive pregnancy test or is breast-feeding or currently trying to become pregnant
* Has a positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (anti-HCV)
* Has a positive test for drugs of abuse at screening or baseline (dosing)
* Has difficult venipuncture access and/or refuses to undergo venipuncture
* Has clinically significant renal or hepatic impairment according to the medically qualified Investigator discretion, or presence of a disease, which in the opinion of the Investigator, would preclude the use of IP
* Has a history of peptic ulcers, gastrointestinal bleeding of any etiology, bleeding disorders, gastrointestinal disease (including chronic heartburn or gastroesophageal reflux disease, or any other active inflammatory disease of the gastrointestinal tract such as ulcerative colitis or crohn's disease), or has a history of gastrointestinal surgery (including cholecystectomy) that would affect the pharmacokinetic (PK) assessment of the drug or the safety of the participant
* Has history of substance abuse, as judged by the PI, within 12 months preceding this study
* Has used alcohol within 24 hours of baseline visit and/or has positive alcohol test in expired air at screening or baseline visit
* Has used food or beverages containing xanthines (that is, tea, coffee, cola drinks, energy drinks or chocolate) for 48 hours prior to the dosing and during the study period
* Has used grapefruit and savoy oranges for 48 hours prior to the dosing and during the study period
* Participating in a clinical trial and/or treated with any investigational product within 3 months preceding the dose of study drug
* Has preplanned surgery, procedures, or personal commitments that would interfere with the conduct of the study
* Had an acute blood loss of 50 milliliter (mL) to 249 mL within the 30 days, or 250 mL to 449 mL within the 45 days, or greater than or equal to (\>=) 450 mL within the 60 days before first dose administration
* Has any acute or chronic medical or psychiatric condition(s) that may increase the risk associated with study participation or IP administration or may interfere with the interpretation of study results and, in the judgment of the medically qualified Investigator, would make the participant inappropriate for entry into this study
* Use of Ibuprofen within 6 hours prior to the dose administration of the investigational product
* Use of any vitamins, dietary and herbal supplements within seven days before first dose of study drug
* Has hypersensitivity to acetaminophen, naproxen, other non-steroidal anti-inflammatory drug (NSAIDs), including acetylsalicylic acid, or to any of the ingredients
* If female, has a positive pregnancy test or is breast-feeding or currently trying to become pregnant
* Has a positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (anti-HCV)
* Has a positive test for drugs of abuse at screening or baseline (dosing)
* Has difficult venipuncture access and/or refuses to undergo venipuncture
* Has clinically significant renal or hepatic impairment according to the medically qualified Investigator discretion, or presence of a disease, which in the opinion of the Investigator, would preclude the use of IP
* Has a history of peptic ulcers, gastrointestinal bleeding of any etiology, bleeding disorders, gastrointestinal disease (including chronic heartburn or gastroesophageal reflux disease, or any other active inflammatory disease of the gastrointestinal tract such as ulcerative colitis or crohn's disease), or has a history of gastrointestinal surgery (including cholecystectomy) that would affect the pharmacokinetic (PK) assessment of the drug or the safety of the participant
* Has history of substance abuse, as judged by the PI, within 12 months preceding this study
* Has used alcohol within 24 hours of baseline visit and/or has positive alcohol test in expired air at screening or baseline visit
* Has used food or beverages containing xanthines (that is, tea, coffee, cola drinks, energy drinks or chocolate) for 48 hours prior to the dosing and during the study period
* Has used grapefruit and savoy oranges for 48 hours prior to the dosing and during the study period
* Participating in a clinical trial and/or treated with any investigational product within 3 months preceding the dose of study drug
* Has preplanned surgery, procedures, or personal commitments that would interfere with the conduct of the study
* Had an acute blood loss of 50 milliliter (mL) to 249 mL within the 30 days, or 250 mL to 449 mL within the 45 days, or greater than or equal to (\>=) 450 mL within the 60 days before first dose administration
* Has any acute or chronic medical or psychiatric condition(s) that may increase the risk associated with study participation or IP administration or may interfere with the interpretation of study results and, in the judgment of the medically qualified Investigator, would make the participant inappropriate for entry into this study
Minimum Eligible Age
12 Years
Maximum Eligible Age
16 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Johnson & Johnson Consumer Inc. (J&JCI)
INDUSTRY
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Johnson & Johnson Consumer Inc. (J&JCI) Clinical Trial
Role: STUDY_DIRECTOR
Johnson & Johnson Consumer Inc. (J&JCI)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
JBR Clinical Research LLP
Salt Lake City, Utah, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
McGilveray IJ, Mattok GL, Fooks JR, et al. Acetaminophen II: A comparison of the physiological availabilities of different commercial dosage forms. Can J Pharmaceut Sci 1971;6:38-42.
Reference Type
BACKGROUND
Liu DJ, Collaku A, Youngberg SP. Bioavailability and pharmacokinetic profile of a newly-developed twice-a-day sustained-release paracetamol formulation. Int J Clin Pharmacol Ther. 2015 Feb;53(2):172-81. doi: 10.5414/CP202146.
Reference Type
BACKGROUND
Paracetamol. In: Sweetman S, ed. Martindale - The Complete Drug Reference. London, UK: The Pharmaceutical Press. 37th ed. 2011:76-79.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Grosser T, Smyth E, FitzGerald. Anti-Inflammatory, Antipyretic, and Analgesic Agents; Pharmacotherapy of Gout. In: Goodman LS, Brunton LL, Chabner B, Knollman BC. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 12th ed. New York, McGraw-Hill. 2011:959- 1004.
Reference Type
BACKGROUND
McNeil Consumer & Specialty Pharmaceuticals Clinical Pharmacology Report for Protocol 02- 161: Tolerability and multiple-dose pharmacokinetics of acetaminophen (paracetamol) at and above the currently recommended dose. Fort Washington, PA. McNeil Consumer & Specialty Pharmaceuticals Company. Aug 2005.
Reference Type
BACKGROUND
McNeil Consumer Products Company Statistical Report 7: Interim statistical analysis of the study of the bioavailability and antipyretic effectiveness of acetaminophen in children. Fort Washington, PA. McNeil Consumer Products Company. Dec 1978. [Meta-Analysis Code P00102]
Reference Type
BACKGROUND
McNeil Consumer Products Company Statistical Report 65 for Protocol 0-220: A double-blind multiple-dose study of the comparative antipyretic effectiveness and safety of standard and double standard doses of acetaminophen in febrile children. Fort Washington, PA. McNeil Consumer Products Company. Jun 1986. [Meta-Analysis Code P80220]
Reference Type
BACKGROUND
McNeil Protocol 2-227 Data Listings. A double-blind study of the comparative antipyretic effectiveness and safety of a single 15 mg/kg, 30 mg/kg or 40 mg/kg dose of acetaminophen. Oct 1982 [Meta-Analysis Code P82227]
Reference Type
BACKGROUND
McNeil Consumer Products Company Report for Protocol 93-308: Pharmacokinetic and pharmacodynamic modeling of acetaminophen in febrile children: Evaluation of three products. Fort Washington, PA. McNeil Consumer Products Company. 1994. [Meta-Analysis Code P93308]
Reference Type
BACKGROUND
McNeil Consumer Products Company Data Listings for Protocol 1-224: A double-blind study of the comparative antipyretic effectiveness and safety of a single 10 mg/kg, 20 mg/kg or 30 mg/kg dose of acetaminophen. Sep 1981. [Meta-Analysis Code P81224]
Reference Type
BACKGROUND
Ji P, Wang Y, Li Z, Doddapaneni S, Hertz S, Furness S, Sahajwalla CG. Regulatory review of acetaminophen clinical pharmacology in young pediatric patients. J Pharm Sci. 2012 Dec;101(12):4383-9. doi: 10.1002/jps.23331. Epub 2012 Oct 16.
Reference Type
BACKGROUND
Wilson JT, Brown RD, Bocchini JA Jr, Kearns GL. Efficacy, disposition and pharmacodynamics of aspirin, acetaminophen and choline salicylate in young febrile children. Ther Drug Monit. 1982;4(2):147-80. doi: 10.1097/00007691-198206000-00003. No abstract available.
Reference Type
BACKGROUND
Levy G. Comparative pharmacokinetics of aspirin and acetaminophen. Arch Intern Med. 1981 Feb 23;141(3 Spec No):279-81. doi: 10.1001/archinte.141.3.279.
Reference Type
BACKGROUND
Milligan TP, Morris HC, Hammond PM, Price CP. Studies on paracetamol binding to serum proteins. Ann Clin Biochem. 1994 Sep;31 ( Pt 5):492-6. doi: 10.1177/000456329403100512.
Reference Type
BACKGROUND
Forrest JA, Clements JA, Prescott LF. Clinical pharmacokinetics of paracetamol. Clin Pharmacokinet. 1982 Mar-Apr;7(2):93-107. doi: 10.2165/00003088-198207020-00001.
Reference Type
BACKGROUND
Paracetamol In: Dollery C., editor. Therapeutic drugs. 2nd ed. Vol 2. Edinburgh: Churchill Livingstone. 1999
Reference Type
BACKGROUND
Peterson RG, Rumack BH. Pharmacokinetics of acetaminophen in children. Pediatrics. 1978 Nov;62(5 Pt 2 Suppl):877-9.
Reference Type
BACKGROUND
Davies NM, Anderson KE. Clinical pharmacokinetics of naproxen. Clin Pharmacokinet. 1997 Apr;32(4):268-93. doi: 10.2165/00003088-199732040-00002.
Reference Type
BACKGROUND
Product Monograph for Aleve (Naproxen Sodium Tablets USP/Liquid Gels/Capsules 220 mg). Bayer Inc. Consumer Care. Revised January 8th, 2015.
Reference Type
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.
Reference Type
BACKGROUND
Segre EJ. Naproxen sodium (Anaprox): pharmacology, pharmacokinetics and drug interactions. J Reprod Med. 1980 Oct;25(4 Suppl):222-5.
Reference Type
BACKGROUND
Sevelius H, Runkel R, Segre E, Bloomfield SS. Bioavailability of naproxen sodium and its relationship to clinical analgesic effects. Br J Clin Pharmacol. 1980 Sep;10(3):259-63. doi: 10.1111/j.1365-2125.1980.tb01753.x.
Reference Type
BACKGROUND
Setiawati S et al. Bioequivalence study with two naproxen sodium tablet formulations in healthy subjects. J Bioequival Availab 2009;1: 28-33.
Reference Type
BACKGROUND
Inc., P., PRODUCT MONOGRAPH, PEDIAPHARM NAPROXEN SUSPENSION, naproxen, 25 mg/mL Suspension, USP, Non-Steroidal Anti-Inflammatory Drug (NSAID) 2018.
Reference Type
BACKGROUND
Valitalo P, Kumpulainen E, Manner M, Kokki M, Lehtonen M, Hooker AC, Ranta VP, Kokki H. Plasma and cerebrospinal fluid pharmacokinetics of naproxen in children. J Clin Pharmacol. 2012 Oct;52(10):1516-26. doi: 10.1177/0091270011418658. Epub 2011 Nov 8.
Reference Type
BACKGROUND
Altman RD. A rationale for combining acetaminophen and NSAIDs for mild-to-moderate pain. Clin Exp Rheumatol. 2004 Jan-Feb;22(1):110-7.
Reference Type
BACKGROUND
Ong CK, Seymour RA, Lirk P, Merry AF. Combining paracetamol (acetaminophen) with nonsteroidal antiinflammatory drugs: a qualitative systematic review of analgesic efficacy for acute postoperative pain. Anesth Analg. 2010 Apr 1;110(4):1170-9. doi: 10.1213/ANE.0b013e3181cf9281. Epub 2010 Feb 8.
Reference Type
BACKGROUND
Mehlisch DR, Aspley S, Daniels SE, Southerden KA, Christensen KS. A single-tablet fixed-dose combination of racemic ibuprofen/paracetamol in the management of moderate to severe postoperative dental pain in adult and adolescent patients: a multicenter, two-stage, randomized, double-blind, parallel-group, placebo-controlled, factorial study. Clin Ther. 2010 Jun;32(6):1033-49. doi: 10.1016/j.clinthera.2010.06.002.
Reference Type
BACKGROUND
Palma-Aguirre JA, Villalpando-Hernandez J, Novoa-Heckel G, Oliva I, Carino L, Lopez-Bojorquez E, Burke-Fraga V, Namur S, Gonzalez-de la Parra M. Bioavailability of two oral-tablet and two oral-suspension formulations of naproxen sodium/paracetamol (acetaminophen): single-dose, randomized, open-label, two-period crossover comparisons in healthy Mexican adult subjects. Clin Ther. 2009 Feb;31(2):399-410. doi: 10.1016/j.clinthera.2009.02.002.
Reference Type
BACKGROUND
Topolski F, Moro A, Correr GM, Schimim SC. Optimal management of orthodontic pain. J Pain Res. 2018 Mar 16;11:589-598. doi: 10.2147/JPR.S127945. eCollection 2018.
Reference Type
BACKGROUND
Cheng C, Xie T, Wang J. The efficacy of analgesics in controlling orthodontic pain: a systematic review and meta-analysis. BMC Oral Health. 2020 Sep 18;20(1):259. doi: 10.1186/s12903-020-01245-w.
Reference Type
BACKGROUND
Monk AB, Harrison JE, Worthington HV, Teague A. Pharmacological interventions for pain relief during orthodontic treatment. Cochrane Database Syst Rev. 2017 Nov 28;11(11):CD003976. doi: 10.1002/14651858.CD003976.pub2.
Reference Type
BACKGROUND
Krishnan V. Orthodontic pain: from causes to management--a review. Eur J Orthod. 2007 Apr;29(2):170-9. doi: 10.1093/ejo/cjl081.
Reference Type
BACKGROUND
Polat O, Karaman AI, Durmus E. Effects of preoperative ibuprofen and naproxen sodium on orthodontic pain. Angle Orthod. 2005 Sep;75(5):791-6. doi: 10.1043/0003-3219(2005)75[791:EOPIAN]2.0.CO;2.
Reference Type
BACKGROUND
Zarif Najafi H, Oshagh M, Salehi P, Babanouri N, Torkan S. Comparison of the effects of preemptive acetaminophen, ibuprofen, and meloxicam on pain after separator placement: a randomized clinical trial. Prog Orthod. 2015;16:34. doi: 10.1186/s40510-015-0104-y. Epub 2015 Oct 14.
Reference Type
BACKGROUND
Gritsiuk AI. [On the problem of the effect of prednisolone and salicylates on the fibrinolytic activity of the blood in patients with rheumatism]. Ter Arkh. 1967 Sep;39(9):60-1. No abstract available. Russian.
Reference Type
BACKGROUND
Harrington JT, Isner JM, Kassirer JP. Our national obsession with potassium. Am J Med. 1982 Aug;73(2):155-9. doi: 10.1016/0002-9343(82)90171-1. No abstract available.
Reference Type
BACKGROUND
Bernhardt MK, Southard KA, Batterson KD, Logan HL, Baker KA, Jakobsen JR. The effect of preemptive and/or postoperative ibuprofen therapy for orthodontic pain. Am J Orthod Dentofacial Orthop. 2001 Jul;120(1):20-7. doi: 10.1067/mod.2001.115616.
Reference Type
BACKGROUND
U.S. Department of Health and Human Services, Food and Drug Administration. Center for Drug Evaluation and Research (CDER); Center for Biologics Evaluation and Research (CBER). Population Pharmacokinetics, Guidance for Industry. (February 2022). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/population-pharmacokinetics
Reference Type
BACKGROUND
U.S. Department of Health and Human Services, Food and Drug Administration. Center for Drug Evaluation and Research (CDER). General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products. Guidance for Industry (Draft). (September 2022). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-clinical-pharmacologyconsiderations- pediatric-studies-drugs-including-biological-products
Reference Type
BACKGROUND
Wang Y, Jadhav PR, Lala M, Gobburu JV. Clarification on precision criteria to derive sample size when designing pediatric pharmacokinetic studies. J Clin Pharmacol. 2012 Oct;52(10):1601-6. doi: 10.1177/0091270011422812. Epub 2011 Dec 12. No abstract available.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CCSPAP005203
Identifier Type: OTHER
Identifier Source: secondary_id
CCSPAP005203
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Efficacy of Combined Ibuprofen and Acetaminophen Therapy Versus Ibuprofen Alone Versus Placebo Alone for Pain Management
NCT04059172
RECRUITING
EARLY_PHASE1
Evaluation of the Efficacy of Novel Ibuprofen Acetaminophen Combination Formulations in the Treatment of Post-surgical Dental Pain
NCT01559259
COMPLETED
PHASE2
Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain
NCT01280591
COMPLETED
PHASE3
A Study to Assess Menstrual Cramp Pain Associated With Primary Dysmenorrhea
NCT03448536
COMPLETED
PHASE4
Assessing the Analgesic Efficacy of Naproxen Sodium in Postsurgical Dental Pain.
NCT00720057
COMPLETED
PHASE3
An Effectiveness and Safety Study of Acetaminophen 1000 mg and Ibuprofen 400 mg in Postoperative Dental Pain.
NCT00240825
COMPLETED
PHASE4
An Effectiveness and Safety Study of Acetaminophen Extended Release Caplets in Treating Muscle Aches and Soreness That Occur After a Marathon Race
NCT00240851
COMPLETED
PHASE4
Open-Label, Placebo-Controlled, Parallel Group Study in Healthy Volunteers to Evaluate the Effects of Two Single MT 400 or Naproxen Sodium Tablets
NCT00596245
COMPLETED
PHASE1
Pharmacokinetic Interaction Between Ibuprofen and Acetaminophen Oral Suspension
NCT05428293
COMPLETED
PHASE1
Safety and Efficacy of Intravenous Acetaminophen (IV APAP) in Adult Inpatients
NCT00598559
COMPLETED
PHASE3
To Evaluate the Safety and Efficacy of Acetaminophen 650 mg and 1000mg in Dental Pain After Surgery
NCT01115673
COMPLETED
PHASE3
An Effectiveness and Safety Study Comparing Acetaminophen (3900 mg/Day) to Ibuprofen (1200 mg/Day) in the Treatment of Post-Race Muscle Soreness.
NCT00240838
COMPLETED
PHASE4
Acetaminophen-Protein Adduct Resolution
NCT01021410
COMPLETED
An Effectiveness and Safety Study of Acetaminophen 1000 mg and Ibuprofen 400 mg in Postoperative Dental Pain
NCT00240864
COMPLETED
PHASE4
Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine
NCT01118273
COMPLETED
PHASE4
Evaluate Onset of Action of a Fast Release Aspirin
NCT01420094
COMPLETED
PHASE3
Randomized, Double-Blind, Single-Dose, Efficacy and Safety Study of Test Acetaminophen Tablet in Postoperative Dental Pain
NCT03224403
COMPLETED
PHASE3
Post-operative Dental Pain Study Comparing Analgesic Efficacy
NCT01082081
COMPLETED
PHASE4
Bioequivalence Study of Dr.Reddy's Ibuprofen and Diphenhydramine Citrate 200 mg/38 mg Caplets Under Fasting Condition
NCT01053208
COMPLETED
PHASE1
A Safety and Effectiveness Study of Acetaminophen Extended Release (3900 mg/Day) and Ibuprofen (1200 mg/Day) in the Treatment of Pain Associated With Ankle Sprains.
NCT00261560
COMPLETED
PHASE4
Evaluate Efficacy and Safety of Extended Release (ER) Naproxen Sodium
NCT01389284
COMPLETED
PHASE3
A Randomized Crossover Study to Determine the Pharmacokinetics of Intranasally Administered Acetaminophen in Healthy Adults
NCT00855049
WITHDRAWN
NA
Investigation of Efficacy of Improved Acetaminophen Labeling
NCT01592448
COMPLETED
A Study Comparing the Efficacy and Safety of Orally Administered Ibuprofen and Placebo in Delayed Onset Muscle Soreness
NCT02113566
COMPLETED
PHASE4
Bioequivalence Study of Dr.Reddy's Ibuprofen and Diphenhydramine Citrate 200 mg/38 mg Caplets Under Fed Condition
NCT01053338
COMPLETED
PHASE1