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Study Comparing Coristina® D to Resfenol® in the Symptomatic Treatment of Common Cold

Primary Purpose

Cold

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Resfenol
Coristina d
Sponsored by
Brainfarma Industria Química e Farmacêutica S/A
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cold focused on measuring Common cold treatment

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Corisitina D

    Resfenol

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Likert Scale for symptons
    It will be used a Likert Scale to evaluate the intensity of cold symptoms. It will be used at screening, between 3-5 days of randomization and between 1 to 3 days after the last dose.
    Sleep Questionnaire
    It will be used a Sleep questionnaire to evaluate the sleep quality. It will be used at screening, between 3-5 days of randomization and between 1 to 3 days after the last dose.
    Daily Activities
    It will be used a daily activities questionnaire to evaluate the physical and mental disposition on the routine daily activities. It will be used at screening, between 3-5 days of randomization and between 1 to 3 days after the last dose.
    Adverse Events
    It will be evaluated and monitored the adverse events in order to assess the patient safety. It will be evaluated from randomization up to 1-3 days after last dose.

    Full Information

    First Posted
    March 18, 2016
    Last Updated
    April 6, 2016
    Sponsor
    Brainfarma Industria Química e Farmacêutica S/A
    Collaborators
    Techtrials Pesquisa e Tecnologia Ltda, Pharmagenix
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02735070
    Brief Title
    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

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2016 (undefined)
    Primary Completion Date
    March 2017 (Anticipated)
    Study Completion Date
    March 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Brainfarma Industria Química e Farmacêutica S/A
    Collaborators
    Techtrials Pesquisa e Tecnologia Ltda, Pharmagenix

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cold
    Keywords
    Common cold treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    366 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Corisitina D
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Resfenol
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Resfenol
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Coristina d
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Global Evaluation from 1 to 3 days after last dose
    Description
    The primary outcome will be the global evaluation from investigator to be done from 1 to 3 days after the last dose.
    Time Frame
    From 1 to 3 days after the last dose
    Secondary Outcome Measure Information:
    Title
    Likert Scale for symptons
    Description
    It will be used a Likert Scale to evaluate the intensity of cold symptoms. It will be used at screening, between 3-5 days of randomization and between 1 to 3 days after the last dose.
    Time Frame
    From the screening until 1 to 3 days after the last dose
    Title
    Sleep Questionnaire
    Description
    It will be used a Sleep questionnaire to evaluate the sleep quality. It will be used at screening, between 3-5 days of randomization and between 1 to 3 days after the last dose.
    Time Frame
    From the screening until 1 to 3 days after the last dose
    Title
    Daily Activities
    Description
    It will be used a daily activities questionnaire to evaluate the physical and mental disposition on the routine daily activities. It will be used at screening, between 3-5 days of randomization and between 1 to 3 days after the last dose.
    Time Frame
    From the screening until 1 to 3 days after the last dose
    Title
    Adverse Events
    Description
    It will be evaluated and monitored the adverse events in order to assess the patient safety. It will be evaluated from randomization up to 1-3 days after last dose.
    Time Frame
    From the randomization until 1 to 3 days after the last dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rosária Vastella
    Phone
    551130339742
    Email
    rosariavastella@ttrial.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Juliana V Petti
    Phone
    551130339741
    Email
    julianapetti@ttrials.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Márcio Antônio Pereira, Dr.
    Organizational Affiliation
    MAP Clínica de Endocrinologia Ltda
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Amanda Faulhaber, Dr.
    Organizational Affiliation
    Pesquisare Saude S/S Ltda
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Clóvis Eduardo S Galvão, Dr.
    Organizational Affiliation
    Instituto de Pesquisa Clínica e Medicina Avançada - IMA
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Antônio Carlos da Silva, Dr.
    Organizational Affiliation
    Clinilive
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Paula YU Tokunaga, Dr.
    Organizational Affiliation
    Centro de Estudos Clínicos do Interior Paulista - CECIP
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Carlos I Filho, Dr.
    Organizational Affiliation
    Unidade de Pesquisa Clínica do Centro de Medicina Reprodutiva Dr.Carlos Isaia Filho Ltda.
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Durval C Kraychete, Dr.
    Organizational Affiliation
    CTD Dor Clinica de Diagnostico e Terapia da Dor Ltda
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Lívia FA Oliveira, Dr.
    Organizational Affiliation
    Universidade Federal do Triângulo Mineiro - Núcleo de Estudos Clínicos
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Flávio Sano, Dr.
    Organizational Affiliation
    Departamento Centro de Estudos do Hospital Nipo-Brasileiro
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Martti A Antila, Dr.
    Organizational Affiliation
    Clínica de Alergia Martti Antila S/C Ltda
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    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.
    Citations:
    PubMed Identifier
    22336807
    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.
    Results Reference
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    24468694
    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.
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    24261438
    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.
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    Citation
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    15288679
    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.
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    Links:
    URL
    http://portal.anvisa.gov.br/wps/wcm/connect/8e558300474586988fcfdf3fbc4c6735/sistema+WHO-UMC_2_.pdf?MOD=AJPERES
    Description
    The Uppsala Monitoring Centre (UMC) - World Healthy Organization (WHO) causal categories

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    Study Comparing Coristina® D to Resfenol® in the Symptomatic Treatment of Common Cold

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