Clinical trial NCT02735070: Study Comparing Coristina® D to Resfenol® in the Symptomatic Treatment of Common Cold
Official title: Phase III Study Comparing Coristina® D to Resfenol® in the Symptomatic Treatment of Common Cold
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cold
Keywords: Common cold treatment
Lead sponsor: Brainfarma Industria Química e Farmacêutica S/A
Sponsor class: INDUSTRY
Collaborators: name: Techtrials Pesquisa e Tecnologia Ltda
name: Pharmagenix
First posted: 2016-04-12
Enrollment: 366
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the non-inferiority of Coristina® d in the symptomatic treatment of the common cold compared to Resfenol® comparator.

Detailed description: Eligible patients must sign the informed consent form and they will be between 18 and 60 years old and common cold symptoms for no more than 72 hours.

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

Eligibility criteria: Inclusion Criteria:

1. Sign and date the informed consent form;
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:

1. Presence of suggestive symptoms or prior diagnosis requiring regular and continuous treatment of allergic rhinitis or asthma in the last 2 years;
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).

Primary outcomes:
measure: Global Evaluation from 1 to 3 days after last dose
timeFrame: From 1 to 3 days after the last dose
Secondary outcomes:
measure: Likert Scale for symptons
timeFrame: From the screening until 1 to 3 days after the last dose
measure: Sleep Questionnaire
timeFrame: From the screening until 1 to 3 days after the last dose
measure: Daily Activities
timeFrame: From the screening until 1 to 3 days after the last dose
measure: Adverse Events
timeFrame: From the randomization until 1 to 3 days after the last dose
Other outcomes:
Locations:
Study officials:
affiliation: MAP Clínica de Endocrinologia Ltda
name: Márcio Antônio Pereira, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Pesquisare Saude S/S Ltda
name: Amanda Faulhaber, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Pesquisa Clínica e Medicina Avançada - IMA
name: Clóvis Eduardo S Galvão, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinilive
name: Antônio Carlos da Silva, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro de Estudos Clínicos do Interior Paulista - CECIP
name: Paula YU Tokunaga, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Unidade de Pesquisa Clínica do Centro de Medicina Reprodutiva Dr.Carlos Isaia Filho Ltda.
name: Carlos I Filho, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: CTD Dor Clinica de Diagnostico e Terapia da Dor Ltda
name: Durval C Kraychete, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal do Triângulo Mineiro - Núcleo de Estudos Clínicos
name: Lívia FA Oliveira, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Departamento Centro de Estudos do Hospital Nipo-Brasileiro
name: Flávio Sano, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Clínica de Alergia Martti Antila S/C Ltda
name: Martti A Antila, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Bula Coristina d (Nov 2012, atualizada em 2014).
citation: Micromedex novembro de 2015: ácido acetilsalicílico Micromedex novembro de 2015: dexclorfeniramina
citation: Bantz EW, Dolen WK, Chadwick EW, Nelson HS. Chronic chlorpheniramine therapy: subsensitivity, drug metabolism, and compliance. Ann Allergy. 1987 Nov;59(5):341-6.
citation: 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.
citation: 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.
citation: Product Information: Polaramine(R), dexchlorpheniramine maleate. Schering Corporation, Kenilworth, NJ, 1990.
citation: 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.
citation: Micromedex novembro de 2015: fenilefrina
citation: 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.
citation: Hengstmann JH, Goronzy J. Pharmacokinetics of 3H-phenylephrine in man. Eur J Clin Pharmacol. 1982;21(4):335-41. doi: 10.1007/BF00637623.
citation: Product Information: phenylephrine hydrochloride injection solution, phenylephrine hydrochloride injection solution. PARENTA Pharmaceuticals, Inc, West Columbia, SC.
citation: Micromedex novembro de 2015: cafeína
citation: 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.
citation: Bula Resfenol - Laboratorios Kleyhertz (Data da bula: 21/05/2014).
citation: Brochura Coristina d - Hypermarcas AS.
citation: 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.
citation: Chow, Shao and Wang. Sample Size Calculations. In Clinical Research. Taylor & Francis, NY. (2003): Página 88.
citation: 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.
citation: Pinto VF. Estudos clínicos de não-inferioridade: fundamentos e controvérsias. J Vasc Bras; 2010, v.9, n.3.