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

This study is not yet open for participant recruitment.
Verified April 2016 by Brainfarma Industria Química e Farmacêutica S/A
Sponsor:
ClinicalTrials.gov Identifier:
NCT02735070
First Posted: April 12, 2016
Last Update Posted: April 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Techtrials Pesquisa e Tecnologia Ltda
Pharmagenix
Information provided by (Responsible Party):
Brainfarma Industria Química e Farmacêutica S/A
  Purpose
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.

Condition Intervention Phase
Cold Drug: Resfenol Drug: Coristina d Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Phase III Study Comparing Coristina® D to Resfenol® in the Symptomatic Treatment of Common Cold

Resource links provided by NLM:


Further study details as provided by Brainfarma Industria Química e Farmacêutica S/A:

Primary Outcome Measures:
  • Global Evaluation from 1 to 3 days after last dose [ Time Frame: From 1 to 3 days after the 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 [ Time Frame: From the screening until 1 to 3 days after the last dose ]
    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 [ Time Frame: From the screening until 1 to 3 days after the last dose ]
    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 [ Time Frame: From the screening until 1 to 3 days after the last dose ]
    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 [ Time Frame: From the randomization until 1 to 3 days after the last dose ]
    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.


Estimated Enrollment: 366
Study Start Date: September 2016
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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.
Active Comparator: 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.
Drug: 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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02735070


Contacts
Contact: Rosária Vastella 551130339742 rosariavastella@ttrial.com
Contact: Juliana V Petti 551130339741 julianapetti@ttrials.com

Sponsors and Collaborators
Brainfarma Industria Química e Farmacêutica S/A
Techtrials Pesquisa e Tecnologia Ltda
Pharmagenix
Investigators
Principal Investigator: 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
  More Information

Publications:
Bula Coristina d (Nov 2012, atualizada em 2014).
Micromedex novembro de 2015: ácido acetilsalicílico Micromedex novembro de 2015: dexclorfeniramina
Product Information: Polaramine(R), dexchlorpheniramine maleate. Schering Corporation, Kenilworth, NJ, 1990.
Micromedex novembro de 2015: fenilefrina
Product Information: phenylephrine hydrochloride injection solution, phenylephrine hydrochloride injection solution. PARENTA Pharmaceuticals, Inc, West Columbia, SC.
Micromedex novembro de 2015: cafeína
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.
Pinto VF. Estudos clínicos de não-inferioridade: fundamentos e controvérsias. J Vasc Bras; 2010, v.9, n.3.

Responsible Party: Brainfarma Industria Química e Farmacêutica S/A
ClinicalTrials.gov Identifier: NCT02735070     History of Changes
Other Study ID Numbers: Coristina® d
First Submitted: March 18, 2016
First Posted: April 12, 2016
Last Update Posted: April 12, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.


Keywords provided by Brainfarma Industria Química e Farmacêutica S/A:
Common cold treatment

Additional relevant MeSH terms:
Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases