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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	341 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (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
Study Start Date :	July 2013
Actual Primary Completion Date :	August 2015
Actual Study Completion Date :	August 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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 :

1. 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

Eligibility Criteria

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

Criteria

• 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

Contacts and Locations

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Locations

Brazil
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

Novartis

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT01448057 History of Changes
Other Study ID Numbers:	381-A-301
First Posted:	October 7, 2011
Results First Posted:	January 13, 2017
Last Update Posted:	March 3, 2017
Last Verified:	January 2017

Keywords provided by Novartis:

Paracetamol; dimethindene maleate; phenylephrine hydrochloride; cold and flu symptoms

Additional relevant MeSH terms:

Respiratory Tract Infections; Sneezing; Infection; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Acetaminophen; Phenylephrine; Oxymetazoline; Maleic acid; Dimethindene; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents	Physiological Effects of Drugs; Antipyretics; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Cardiotonic Agents; Mydriatics; Autonomic Agents; Sympathomimetics; Vasoconstrictor Agents; Nasal Decongestants; Respiratory System Agents; Adrenergic alpha-1 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents