Study Comparing Coristina® D to Resfenol® in the Symptomatic Treatment of Common Cold
NCT ID: NCT02735070
Last Updated: 2016-04-12
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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UNKNOWN
PHASE3
366 participants
INTERVENTIONAL
2016-09-30
2017-03-31
Brief Summary
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Detailed Description
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It will be recruited for this study 366 patients, 183 patients per group. It is estimated that the total number of patients can be recruited in 4 to 6 months from the regulatory approval of the study.
The patient will stay in the study approximately 7 to 10 days (including screening visit / randomization, telephone contact in 3 to 5 days after randomization and final visit from 1 to 3 days after last dose).
Study medication (Coristina d and Resfenol) will be provided by the sponsor and will be appropriately labeled for the clinical study, containing the sponsor information, the trial identification, expiration date, batch and storage conditions
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Corisitina D
The patient will use the medication 4 times a day - orally The tablets of Coristina® d contain 400 mg acetylsalicylic acid, dexchlorpheniramine 1 mg, 10 mg phenylephrine, and 30 mg of caffeine. Coristina® d is indicated as an analgesic, antipyretic, antiallergic, and nasal congestion for the treatment of the symptoms of influenza and common cold.
Coristina d
Patients included in the study will take the drugs 4 times a day, orally. Patients should take the study medication without breaking or chewing together with a cup containing approximately 200 ml of water. The patient should ingest the study drug after fasting for at least 30 minutes.
Resfenol
The patient will use the medication 4x / day - orally Resfenol® drug acts against the symptoms of colds and flu, such as nasal congestion, runny nose, fever, headache, muscle pain and other symptoms. The capsules containing 400mg of paracetamol, 4 mg chlorpheniramine and 4mg phenylephrine.
Resfenol
Patients should take the study medication without breaking or chewing together with a cup containing approximately 200 ml of water. The patient should ingest the study drug after fasting for at least 30 minutes.
Interventions
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Resfenol
Patients should take the study medication without breaking or chewing together with a cup containing approximately 200 ml of water. The patient should ingest the study drug after fasting for at least 30 minutes.
Coristina d
Patients included in the study will take the drugs 4 times a day, orally. Patients should take the study medication without breaking or chewing together with a cup containing approximately 200 ml of water. The patient should ingest the study drug after fasting for at least 30 minutes.
Eligibility Criteria
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Inclusion Criteria
2. Age between 18 and 60 years old;
3. Symptoms of common cold not exceeding 72 hours must be present;
4. It will be considered symptoms of the common cold the presence of at least 2 of the 10 symptoms following: runny nose, sneezing, nasal congestion, headache, myalgia, throat discomfort or sore throat, hoarseness, cough or fever. Each of the symptoms listed above will receive a score by Likert scale (no symptom = 0, mild symptoms = 1, moderate symptoms = 2, intense symptoms = 3). The minimum total is 0 and maximum one is 30, which included patients with score higher or equal to 4 points.
Exclusion Criteria
2. Chronic disease of any kind that is contraindicate the participation of the patient based on the opinion of investigator;
3. Hypersensitivity or contraindication to use of components of the study medications;
4. Pregnant or women of childbearing age without adequate contraception;
5. Use of other anti-influenza drugs programmed during the study or for the last 5 days;
6. Regular active smokers (more than 3 cigarettes a day);
7. Participation in another clinical study in less than one year (unless justified benefit by the investigator).
18 Years
60 Years
ALL
No
Sponsors
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Techtrials Pesquisa e Tecnologia Ltda
UNKNOWN
Pharmagenix
UNKNOWN
Brainfarma Industria Química e Farmacêutica S/A
INDUSTRY
Responsible Party
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Principal Investigators
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Márcio Antônio Pereira, Dr.
Role: PRINCIPAL_INVESTIGATOR
MAP Clínica de Endocrinologia Ltda
Amanda Faulhaber, Dr.
Role: PRINCIPAL_INVESTIGATOR
Pesquisare Saude S/S Ltda
Clóvis Eduardo S Galvão, Dr.
Role: PRINCIPAL_INVESTIGATOR
Instituto de Pesquisa Clínica e Medicina Avançada - IMA
Antônio Carlos da Silva, Dr.
Role: PRINCIPAL_INVESTIGATOR
Clinilive
Paula YU Tokunaga, Dr.
Role: PRINCIPAL_INVESTIGATOR
Centro de Estudos Clínicos do Interior Paulista - CECIP
Carlos I Filho, Dr.
Role: PRINCIPAL_INVESTIGATOR
Unidade de Pesquisa Clínica do Centro de Medicina Reprodutiva Dr.Carlos Isaia Filho Ltda.
Durval C Kraychete, Dr.
Role: PRINCIPAL_INVESTIGATOR
CTD Dor Clinica de Diagnostico e Terapia da Dor Ltda
Lívia FA Oliveira, Dr.
Role: PRINCIPAL_INVESTIGATOR
Universidade Federal do Triângulo Mineiro - Núcleo de Estudos Clínicos
Flávio Sano, Dr.
Role: PRINCIPAL_INVESTIGATOR
Departamento Centro de Estudos do Hospital Nipo-Brasileiro
Martti A Antila, Dr.
Role: PRINCIPAL_INVESTIGATOR
Clínica de Alergia Martti Antila S/C Ltda
Central Contacts
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References
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De Sutter AI, van Driel ML, Kumar AA, Lesslar O, Skrt A. Oral antihistamine-decongestant-analgesic combinations for the common cold. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD004976. doi: 10.1002/14651858.CD004976.pub3.
Allan GM, Arroll B. Prevention and treatment of the common cold: making sense of the evidence. CMAJ. 2014 Feb 18;186(3):190-9. doi: 10.1503/cmaj.121442. Epub 2014 Jan 27. No abstract available.
Picon PD, Costa MB, da Veiga Picon R, Fendt LC, Suksteris ML, Saccilotto IC, Dornelles AD, Schmidt LF. Symptomatic treatment of the common cold with a fixed-dose combination of paracetamol, chlorphenamine and phenylephrine: a randomized, placebo-controlled trial. BMC Infect Dis. 2013 Nov 22;13:556. doi: 10.1186/1471-2334-13-556.
Mizoguchi H, Wilson A, Jerdack GR, Hull JD, Goodale M, Grender JM, Tyler BA. Efficacy of a single evening dose of syrup containing paracetamol, dextromethorphan hydrobromide, doxylamine succinate and ephedrine sulfate in subjects with multiple common cold symptoms. Int J Clin Pharmacol Ther. 2007 Apr;45(4):230-6. doi: 10.5414/cpp45230.
Common Cold Collaborative Group; Robert M, Llorens M, Garcia E, Luria X. Efficacy and tolerability of ebastine 10 mg plus pseudoephedrine 120 mg in the symptomatic relief of the common cold. Eur J Intern Med. 2004 Jul;15(4):242-247. doi: 10.1016/j.ejim.2004.03.009.
Bula Coristina d (Nov 2012, atualizada em 2014).
Micromedex novembro de 2015: ácido acetilsalicílico Micromedex novembro de 2015: dexclorfeniramina
Bantz EW, Dolen WK, Chadwick EW, Nelson HS. Chronic chlorpheniramine therapy: subsensitivity, drug metabolism, and compliance. Ann Allergy. 1987 Nov;59(5):341-6.
Munch EP, Soborg M, Norreslet TT, Mygind N. A comparative study of dexchlorpheniramine maleate sustained release tablets and budesonide nasal spray in seasonal allergic rhinitis. Allergy. 1983 Oct;38(7):517-24. doi: 10.1111/j.1398-9995.1983.tb02361.x.
Pastorello EA, Ortolani C, Gerosa S, Pravettoni V, Codecasa LR, Fugazza A, Zanussi C. Antihistaminic treatment of allergic rhinitis: a double-blind study with terfenadine versus dexchlorpheniramine. Pharmatherapeutica. 1987;5(2):69-75.
Product Information: Polaramine(R), dexchlorpheniramine maleate. Schering Corporation, Kenilworth, NJ, 1990.
Simons FE, Simons KJ, Chung M, Yeh J. The comparative pharmacokinetics of H1-receptor antagonists. Ann Allergy. 1987 Dec;59(6 Pt 2):20-4.
Micromedex novembro de 2015: fenilefrina
Hatton RC, Winterstein AG, McKelvey RP, Shuster J, Hendeles L. Efficacy and safety of oral phenylephrine: systematic review and meta-analysis. Ann Pharmacother. 2007 Mar;41(3):381-90. doi: 10.1345/aph.1H679. Epub 2007 Jan 30.
Hengstmann JH, Goronzy J. Pharmacokinetics of 3H-phenylephrine in man. Eur J Clin Pharmacol. 1982;21(4):335-41. doi: 10.1007/BF00637623.
Product Information: phenylephrine hydrochloride injection solution, phenylephrine hydrochloride injection solution. PARENTA Pharmaceuticals, Inc, West Columbia, SC.
Micromedex novembro de 2015: cafeína
Abbott PJ. Caffeine: a toxicological overview. Med J Aust. 1986 Nov 17;145(10):518-21. doi: 10.5694/j.1326-5377.1986.tb139455.x.
Bula Resfenol - Laboratorios Kleyhertz (Data da bula: 21/05/2014).
Brochura Coristina d - Hypermarcas AS.
Bertolazi NA. Tradução, adaptação cultural e validação de dois instrumentos de avalição do sono: escala de sonolência de Epworth e Índice de Qualidade de Sono de Pittsburgh. Tese de Mestrado apresentada a UFRGS em 2008. Porto Alegre - RS.
Chow, Shao and Wang. Sample Size Calculations. In Clinical Research. Taylor & Francis, NY. (2003): Página 88.
Salisbury-Afshar E. Oral antihistamine/decongestant/analgesic combinations for the common cold. Am Fam Physician. 2012 Nov 1;86(9):812-3. No abstract available.
Pinto VF. Estudos clínicos de não-inferioridade: fundamentos e controvérsias. J Vasc Bras; 2010, v.9, n.3.
Other Identifiers
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Coristina® d
Identifier Type: -
Identifier Source: org_study_id
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