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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

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ClinicalTrials.gov Identifier: NCT01448057
Recruitment Status : Completed
First Posted : October 7, 2011
Results First Posted : January 13, 2017
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Description
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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, Older 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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01448057


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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Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01448057     History of Changes
Other Study ID Numbers: 381-A-301
First Posted: October 7, 2011    Key Record Dates
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