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

Novartis341 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

341

Conditions

Upper Respiratory Tract Infection Nasal Congestion Rhinorrhea Sneezing

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

* 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

Locations (6)

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

: Lal Clinica Centro de Pesquisa e Desenvolvimento Ltda, Rua General Osório, 503, Vila Martina / Valinhos

São Paulo, Brazil

Associacao Fundo De Incentivo A Pesquisa - AFIP - Rua Marselhesa 500 - Vila Clementino

São Paulo, Brazil

Outcomes

Primary Outcomes

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. 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

Time frame: Day 2

Secondary Outcomes

Daily Average of the Sum of a 100 mm Visual Analog Scale for All Symptoms

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

Time frame: Day 3