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

• Status: Unknown status
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brainfarma Industria Química e Farmacêutica S/A
• Collaborators: Pharmagenix; Techtrials Pesquisa e Tecnologia Ltda

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).