drugset / Trial / NCT06531707
Efficacy and Safety in the Combination of Ibuprofen / Loratadine Versus Ibuprofen Versus Loratadine
RandomizedParallel-groupDouble-blindTreatment
Summary
Phase III longitudinal, multicenter, randomized, double-blind clinical trial. The aim of this study is to evaluate the efficacy and safety of the drug combination of Ibuprofen/Loratadine versus Ibuprofen versus Loratadine as monotherapy for the symptomatic treatment of the common cold.
Timeline
- Start
- 2024-05-20
- Primary completion
- 2025-01-20
- Completion
- 2025-02-20
Publications
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- Background Eccles R. Efficacy and safety of over-the-counter analgesics in the treatment of common cold and flu. J Clin Pharm Ther. 2006 Aug;31(4):309-19. doi: 10.1111/j.1365-2710.2006.00754.x.
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- Background Zhang J, Kan D. Evaluation of efficiency and safety of combined loratadine and budesonide in patients with anaphylactic rhinitis: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2022 Apr 29;101(17):e28851. doi: 10.1097/MD.0000000000028851.
- Background Anolik R; Mometasone Furoate Nasal Spray With Loratadine Study Group. Clinical benefits of combination treatment with mometasone furoate nasal spray and loratadine vs monotherapy with mometasone furoate in the treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2008 Mar;100(3):264-71. doi: 10.1016/S1081-1206(10)60452-8.
- Background Ratner PH, van Bavel JH, Martin BG, Hampel FC Jr, Howland WC 3rd, Rogenes PR, Westlund RE, Bowers BW, Cook CK. A comparison of the efficacy of fluticasone propionate aqueous nasal spray and loratadine, alone and in combination, for the treatment of seasonal allergic rhinitis. J Fam Pract. 1998 Aug;47(2):118-25.
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- Background Dahlen B, Roquet A, Inman MD, Karlsson O, Naya I, Anstren G, O'Byrne PM, Dahlen SE. Influence of zafirlukast and loratadine on exercise-induced bronchoconstriction. J Allergy Clin Immunol. 2002 May;109(5):789-93. doi: 10.1067/mai.2002.123306.
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- Background Wahbi AA, Hassan E, Hamdy D, Khamis E, Barary M. Spectrophotometric methods for the determination of Ibuprofen in tablets. Pak J Pharm Sci. 2005 Oct;18(4):1-6.
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- Background Varrassi G, Pergolizzi JV, Dowling P, Paladini A. Ibuprofen Safety at the Golden Anniversary: Are all NSAIDs the Same? A Narrative Review. Adv Ther. 2020 Jan;37(1):61-82. doi: 10.1007/s12325-019-01144-9. Epub 2019 Nov 8.
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- Background Zoubek ME, Lucena MI, Andrade RJ, Stephens C. Systematic review: ibuprofen-induced liver injury. Aliment Pharmacol Ther. 2020 Mar;51(6):603-611. doi: 10.1111/apt.15645. Epub 2020 Jan 27.
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibuprofen | Small molecule | 400 mg | Oral |
| Subject | Loratadine | Small molecule | 5 mg | Oral |