Study Comparing Coristina® D to Resfenol® in the Symptomatic Treatment of Common Cold
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|ClinicalTrials.gov Identifier: NCT02735070|
Recruitment Status : Unknown
Verified April 2016 by Brainfarma Industria Química e Farmacêutica S/A.
Recruitment status was: Not yet recruiting
First Posted : April 12, 2016
Last Update Posted : April 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cold||Drug: Resfenol Drug: Coristina d||Phase 3|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||366 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Phase III Study Comparing Coristina® D to Resfenol® in the Symptomatic Treatment of Common Cold|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||March 2017|
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.
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02735070
|Contact: Rosária Vastellaemail@example.com|
|Contact: Juliana V Pettifirstname.lastname@example.org|
|Principal Investigator:||Márcio Antônio Pereira, Dr.||MAP Clínica de Endocrinologia Ltda|
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|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|