Cold Clinical Trial
Official title:
Phase III Study Comparing Coristina® D to Resfenol® in the Symptomatic Treatment of Common Cold
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.
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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