NCT02735070

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 366 (estimated)
• Sponsor: Brainfarma Industria Química e Farmacêutica S/A · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Cold

Interventions

Type	Name	Description
DRUG	Resfenol	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.
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.

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2016-04-12
• Last updated: 2016-04-12