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Status:

COMPLETED

Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu

Lead Sponsor:

Novartis

Conditions:

Upper Respiratory Tract Infection

Nasal Congestion

Eligibility:

All Genders

18-65 years

Phase:

PHASE3

Brief Summary

The study is a clinical evaluation of an over the counter (OTC) combination product containing paracetamol (500 mg), dimethindene maleate (1 mg), phenylephrine hydrochloride (10 mg) compared to parace...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • • acute URTI, diagnosed by a health care professional at the study site, with the following symptoms having started within 72 hours before the screening/baseline Visit: nasal congestion, sneezing, and rhinorrhea.
  • Exclusion criteria:
  • Use of other investigational drugs within 30 days or 10 half-lives before enrollment, whichever is longer.
  • History of or known hypersensitivity to any of the study drugs, excipients or to drugs of similar chemical classes.
  • Other protocol-defined inclusion/exclusion criteria may apply

Exclusion

    Key Trial Info

    Start Date :

    July 1 2013

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 1 2015

    Estimated Enrollment :

    341 Patients enrolled

    Trial Details

    Trial ID

    NCT01448057

    Start Date

    July 1 2013

    End Date

    August 1 2015

    Last Update

    March 3 2017

    Active Locations (6)

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    Page 1 of 2 (6 locations)

    1

    Santa Casa De Misericordia De Belo Horizonte - Avenida Francisco Sales 1111, Santa Efigenia

    Belo Horizonte/MG, Brazil, 30150-221

    2

    Sociedade Campineira De Educacao E Instrucao - Rodovia Dom Pedro I, KM 136 Parque das Universidades

    Campinas/SP, Brazil

    3

    Instituto de Ensino e Pesquisa Clínica do Ceará, Rua Coronel Jucá, 1952 - Dionísio Torres -

    Fortaleza/CE, Brazil, 60170-320

    4

    Polonio Clinica De Servicios Medicos EM Gastroenterologia E Cirurgia Toracica S/S LTDA - ME, Rua Major Alfredo Servulo de Oliveira Romao, 103, Chacara Braz Miraglia

    Jau/SP, Brazil, 17210-070