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

Last updated: April 6, 2016
Sponsor: Brainfarma Industria Química e Farmacêutica S/A
Overall Status: Trial Status Unknown

Phase

3

Condition

Common Cold

Acute Rhinitis

Treatment

N/A

Clinical Study ID

NCT02735070
Coristina® d
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 10symptoms following: runny nose, sneezing, nasal congestion, headache, myalgia, throatdiscomfort or sore throat, hoarseness, cough or fever. Each of the symptoms listedabove 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 oneis 30, which included patients with score higher or equal to 4 points.

Exclusion

Exclusion Criteria:

  1. Presence of suggestive symptoms or prior diagnosis requiring regular and continuoustreatment of allergic rhinitis or asthma in the last 2 years;

  2. Chronic disease of any kind that is contraindicate the participation of the patientbased 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 justifiedbenefit by the investigator).

Study Design

Total Participants: 366
Study Start date:
September 01, 2016
Estimated Completion Date:
March 31, 2017

Study 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