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

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.

Conditions

• Cold

Interventions

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.

Sponsors & Collaborators

• Techtrials Pesquisa e Tecnologia Ltda

  collaborator UNKNOWN

• Pharmagenix

  collaborator UNKNOWN

• Brainfarma Industria Química e Farmacêutica S/A

  lead INDUSTRY

Principal Investigators

• Márcio Antônio Pereira, Dr. · MAP Clínica de Endocrinologia Ltda

• Amanda Faulhaber, Dr. · Pesquisare Saude S/S Ltda

• Clóvis Eduardo S Galvão, Dr. · Instituto de Pesquisa Clínica e Medicina Avançada - IMA

• Antônio Carlos da Silva, Dr. · Clinilive

• Paula YU Tokunaga, Dr. · Centro de Estudos Clínicos do Interior Paulista - CECIP

• Carlos I Filho, Dr. · Unidade de Pesquisa Clínica do Centro de Medicina Reprodutiva Dr.Carlos Isaia Filho Ltda.

• Durval C Kraychete, Dr. · CTD Dor Clinica de Diagnostico e Terapia da Dor Ltda

• Lívia FA Oliveira, Dr. · Universidade Federal do Triângulo Mineiro - Núcleo de Estudos Clínicos

• Flávio Sano, Dr. · Departamento Centro de Estudos do Hospital Nipo-Brasileiro

• Martti A Antila, Dr. · Clínica de Alergia Martti Antila S/C Ltda

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-09-30

Primary Completion

2017-03-31

Completion

2017-03-31