NCT02735070

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
366

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

April 12, 2016

Status Verified

April 1, 2016

Enrollment Period

6 months

First QC Date

March 18, 2016

Last Update Submit

April 6, 2016

Conditions

Cold

Keywords

Common cold treatment

Outcome Measures

Primary Outcomes (1)

  • Global Evaluation from 1 to 3 days after last dose

    The primary outcome will be the global evaluation from investigator to be done from 1 to 3 days after the last dose.

    From 1 to 3 days after the last dose

Secondary Outcomes (4)

  • Likert Scale for symptons

    From the screening until 1 to 3 days after the last dose

  • Sleep Questionnaire

    From the screening until 1 to 3 days after the last dose

  • Daily Activities

    From the screening until 1 to 3 days after the last dose

  • Adverse Events

    From the randomization until 1 to 3 days after the last dose

Study Arms (2)

Corisitina D

EXPERIMENTAL

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.

Drug: Coristina d

Resfenol

ACTIVE COMPARATOR

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.

Drug: Resfenol

Interventions

ResfenolDRUG

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
Coristina dDRUG

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.

Corisitina D

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Sign and date the informed consent form;
  • Age between 18 and 60 years old;
  • Symptoms of common cold not exceeding 72 hours must be present;
  • 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.

You may not qualify if:

  • Presence of suggestive symptoms or prior diagnosis requiring regular and continuous treatment of allergic rhinitis or asthma in the last 2 years;
  • Chronic disease of any kind that is contraindicate the participation of the patient based on the opinion of investigator;
  • Hypersensitivity or contraindication to use of components of the study medications;
  • Pregnant or women of childbearing age without adequate contraception;
  • Use of other anti-influenza drugs programmed during the study or for the last 5 days;
  • Regular active smokers (more than 3 cigarettes a day);
  • Participation in another clinical study in less than one year (unless justified benefit by the investigator).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (24)

  • 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.

    PMID: 22336807RESULT

  • 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.

    PMID: 24468694RESULT

  • 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.

    PMID: 24261438RESULT

  • 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.

    PMID: 17474541RESULT

  • 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.

    PMID: 15288679RESULT

  • Bula Coristina d (Nov 2012, atualizada em 2014).

    RESULT

  • Micromedex novembro de 2015: ácido acetilsalicílico Micromedex novembro de 2015: dexclorfeniramina

    RESULT

  • Bantz EW, Dolen WK, Chadwick EW, Nelson HS. Chronic chlorpheniramine therapy: subsensitivity, drug metabolism, and compliance. Ann Allergy. 1987 Nov;59(5):341-6.

    PMID: 3688558RESULT

  • 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.

    PMID: 6139040RESULT

  • 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.

    PMID: 2889217RESULT

  • Product Information: Polaramine(R), dexchlorpheniramine maleate. Schering Corporation, Kenilworth, NJ, 1990.

    RESULT

  • 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.

    PMID: 2892445RESULT

  • Micromedex novembro de 2015: fenilefrina

    RESULT

  • 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.

    PMID: 17264159RESULT

  • Hengstmann JH, Goronzy J. Pharmacokinetics of 3H-phenylephrine in man. Eur J Clin Pharmacol. 1982;21(4):335-41. doi: 10.1007/BF00637623.

    PMID: 7056280RESULT

  • Product Information: phenylephrine hydrochloride injection solution, phenylephrine hydrochloride injection solution. PARENTA Pharmaceuticals, Inc, West Columbia, SC.

    RESULT

  • Micromedex novembro de 2015: cafeína

    RESULT

  • 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.

    PMID: 3534532RESULT

  • Bula Resfenol - Laboratorios Kleyhertz (Data da bula: 21/05/2014).

    RESULT

  • Brochura Coristina d - Hypermarcas AS.

    RESULT

  • 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.

    RESULT

  • Chow, Shao and Wang. Sample Size Calculations. In Clinical Research. Taylor & Francis, NY. (2003): Página 88.

    RESULT

  • 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.

    PMID: 23113460RESULT

  • Pinto VF. Estudos clínicos de não-inferioridade: fundamentos e controvérsias. J Vasc Bras; 2010, v.9, n.3.

    RESULT

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Márcio Antônio Pereira, Dr.

    MAP Clínica de Endocrinologia Ltda

    PRINCIPAL INVESTIGATOR

  • Amanda Faulhaber, Dr.

    Pesquisare Saude S/S Ltda

    PRINCIPAL INVESTIGATOR

  • Clóvis Eduardo S Galvão, Dr.

    Instituto de Pesquisa Clínica e Medicina Avançada - IMA

    PRINCIPAL INVESTIGATOR

  • Antônio Carlos da Silva, Dr.

    Clinilive

    PRINCIPAL INVESTIGATOR

  • Paula YU Tokunaga, Dr.

    Centro de Estudos Clínicos do Interior Paulista - CECIP

    PRINCIPAL INVESTIGATOR

  • Carlos I Filho, Dr.

    Unidade de Pesquisa Clínica do Centro de Medicina Reprodutiva Dr.Carlos Isaia Filho Ltda.

    PRINCIPAL INVESTIGATOR

  • Durval C Kraychete, Dr.

    CTD Dor Clinica de Diagnostico e Terapia da Dor Ltda

    PRINCIPAL INVESTIGATOR

  • Lívia FA Oliveira, Dr.

    Universidade Federal do Triângulo Mineiro - Núcleo de Estudos Clínicos

    PRINCIPAL INVESTIGATOR

  • Flávio Sano, Dr.

    Departamento Centro de Estudos do Hospital Nipo-Brasileiro

    PRINCIPAL INVESTIGATOR

  • Martti A Antila, Dr.

    Clínica de Alergia Martti Antila S/C Ltda

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosária Vastella

CONTACT

551130339742rosariavastella@ttrial.com

Juliana V Petti

CONTACT

551130339741julianapetti@ttrials.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2016

First Posted

April 12, 2016

Study Start

September 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

April 12, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will share

The data that will be collected are: demographics data; medical history, disease characteristics; Likert scale; physician and patient perception about the study treatment; Sleep Questionnaire; evaluation for daily activities willingness; Safety Assessments; Vital Signs and Physical Examination; additional tests; Adverse Events. All data collected for the study will be recorded, stored and retrieved through electronic case report form designed specifically for this study. All information will be inserted in a database. All data collected for the study will be analyzed centrally by independent scientific consulting company designated for this purpose. The publication of the overall results of the study will be coordinated by the sponsor. The responsibility for the content of the publications will be shared between the sponsor and co-authors, who will participate in the review of the content and give consent for publication.