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

Last updated: January 18, 2017
Sponsor: Novartis
Overall Status: Completed

Phase

3

Condition

Acute Rhinitis

Rhinitis, Allergic, Perennial

Respiratory Syncytial Virus (Rsv) Infection

Treatment

N/A

Clinical Study ID

NCT01448057
381-A-301
  • Ages 18-65
  • All Genders

Study 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 paracetamol (500 mg) alone in the treatment of nasal congestion, rhinorrhea, sneezing and other symptoms due to upper respiratory tract infection (URTI).

Eligibility Criteria

Inclusion

  • Inclusion criteria:

• acute URTI, diagnosed by a health care professional at the study site, with thefollowing symptoms having started within 72 hours before the screening/baseline Visit:nasal congestion, sneezing, and rhinorrhea.

Exclusion

  • Exclusion criteria:

  • Use of other investigational drugs within 30 days or 10 half-lives beforeenrollment, whichever is longer.

  • History of or known hypersensitivity to any of the study drugs, excipients or todrugs of similar chemical classes. Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Total Participants: 341
Study Start date:
July 01, 2013
Estimated Completion Date:
August 31, 2015

Connect with a study center

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

    Belo Horizonte/MG, 30150-221
    Brazil

    Site Not Available

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

    Campinas/SP,
    Brazil

    Site Not Available

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

    Fortaleza/CE, 60170-320
    Brazil

    Site Not Available

  • 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, 17210-070
    Brazil

    Site Not Available

  • Hospital Sao Lucas da PUCRS , Ave. Ipiranga 6690

    Porto Alegre/RS, 90610-000
    Brazil

    Site Not Available

  • Associacao Fundo De Incentivo A Pesquisa - AFIP - Rua Marselhesa 500 - Vila Clementino

    Sao Paulo,
    Brazil

    Site Not Available

  • CEPIC- Centro Paulista de Investigações Clínicas e Serviços Médicos LTDA, Rua Moreira e Costa, 342 - Ipiranga -

    São Paulo/SP, 04266-010
    Brazil

    Site Not Available

  • : Lal Clinica Centro de Pesquisa e Desenvolvimento Ltda, Rua General Osório, 503, Vila Martina / Valinhos

    São Paulo, 13271-130
    Brazil

    Site Not Available

  • CEPIC- Centro Paulista de Investigações Clínicas e Serviços Médicos LTDA, Rua Moreira e Costa, 342 - Ipiranga -

    São Paulo/SP, 04266-010
    Brazil

    Site Not Available

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