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

Upper Respiratory Tract Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01448057
• Other study ID #: 381-A-301
• Status: Completed
• Phase: Phase 3
• First received: October 5, 2011
• Last updated: October 1, 2015
• Start date: July 2013
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Agência Nacional de Vigilância Sanitária do Ministério da Saúde do Brasil - ANVISA/MS
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 341
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasal Congestion
• Respiratory Tract Infections
• Rhinorrhea
• Sneezing
• Upper Respiratory Tract Infection

Intervention

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
• Paracetamol (500 mg) tablets
Paracetamol (500 mg) tablets

Locations

Country	Name	City	State
Brazil	Santa Casa De Misericordia De Belo Horizonte - Avenida Francisco Sales 1111, Santa Efigenia	Belo Horizonte/MG
Brazil	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	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	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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physician Global evaluation of effectiveness on Nasal Symptoms	The Physician will measure the reduction of Nasal Symptoms (Nasal Congestion, Sneezing, and Rhinorrhea) on day 2	up to 3 days	No
Secondary	Sum of subject self assessment using a 100 mm Visual Analog Scale	Subject will assess Nasal Symptoms using a 100 mm Visual Analog Scale	up to 3 days	No