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

• 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: Novartis
• Information provided by (Responsible Party): Novartis

Study Description

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

• 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

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

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

• 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

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

• 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; Dimethindene; Phenylephrine; Oxymetazoline; Maleic acid; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Antipyretics; 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; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action