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

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: October 5, 2011
Last updated: January 18, 2017
Last verified: January 2017
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).

Condition Intervention Phase
Upper Respiratory Tract Infection
Nasal Congestion
Drug: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
Drug: Paracetamol (500 mg) tablets
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Investigator-Blind Study to Compare Three Days of Treatment With Paracetamol (500 mg) / Dimethindene Maleate (1 mg) / Phenylephrine Hydrochloride (10 mg) Tablets Versus Paracetamol 500 mg Alone in the Treatment of Nasal Congestion and Other Symptoms Due to Cold and Flu

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Physician Global Evaluation of Effectiveness on Nasal Symptoms [ Time Frame: Day 2 ]

    The Physician will measure the reduction of Nasal Symptoms (Nasal Congestion, Sneezing, and Rhinorrhea) on day 2.

    Range from 1 to 5 where 1 is excellent and 5 is bad :

    1 = excellent : 75% to 100% remission of signs and symptoms 5 = bad : exacerbation of nasal symptoms

Secondary Outcome Measures:
  • Daily Average of the Sum of a 100 mm Visual Analog Scale for All Symptoms [ Time Frame: Day 3 ]
    Subject will assess Nasal and non Nasal symptoms using a 100 mm Visual Analog Scale for each symptom, 0=no symptoms 100= the worst possible symptoms

Enrollment: 341
Study Start Date: July 2013
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combination Product
Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
Drug: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
Active Comparator: Paracetamol tablets
Paracetamol (500 mg) tablets
Drug: Paracetamol (500 mg) tablets
Paracetamol (500 mg) tablets


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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

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Please refer to this study by its identifier: NCT01448057

Santa Casa De Misericordia De Belo Horizonte - Avenida Francisco Sales 1111, Santa Efigenia
Belo Horizonte/MG, Brazil, 30150-221
Sociedade Campineira De Educacao E Instrucao - Rodovia Dom Pedro I, KM 136 Parque das Universidades
Campinas/SP, Brazil
Instituto de Ensino e Pesquisa Clínica do Ceará, Rua Coronel Jucá, 1952 - Dionísio Torres -
Fortaleza/CE, Brazil, 60170-320
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
Associacao Fundo De Incentivo A Pesquisa - AFIP - Rua Marselhesa 500 - Vila Clementino
Sao Paulo, Brazil
: Lal Clinica Centro de Pesquisa e Desenvolvimento Ltda, Rua General Osório, 503, Vila Martina / Valinhos
São Paulo, Brazil, 13271-130
Sponsors and Collaborators
  More Information

Responsible Party: Novartis Identifier: NCT01448057     History of Changes
Other Study ID Numbers: 381-A-301
Study First Received: October 5, 2011
Results First Received: August 16, 2016
Last Updated: January 18, 2017

Keywords provided by Novartis:
dimethindene maleate
phenylephrine hydrochloride
cold and flu symptoms

Additional relevant MeSH terms:
Respiratory Tract Infections
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Maleic acid
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Cardiotonic Agents
Autonomic Agents
Vasoconstrictor Agents processed this record on April 25, 2017