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

Study Overview
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Brief Summary
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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
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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

Official Title
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Phase III Study Comparing Coristina® D to Resfenol® in the Symptomatic Treatment of Common Cold

Conditions
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Cold

Intervention / Treatment
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* Drug: Resfenol
* Drug: Coristina d


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Corisitina D<br>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<br>* 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.<br>|
| Active Comparator: Resfenol<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From the screening until 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. | From the screening until 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. | From the screening until 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. | From the randomization until 1 to 3 days after the last dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Common cold treatment