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

Phase 3

Completed

• Conditions: Nasal Congestion; Rhinorrhea; Sneezing; Upper Respiratory Tract Infection
• Interventions: Drug: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets; Drug: Paracetamol (500 mg) tablets

• Registration Number: NCT01448057
• Lead Sponsor: Novartis

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-05
• Study First Submitted QC: 2011-10-06
• Study First Posted: 2011-10-07
• Study Start: 2013-07
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Results First Submitted: 2016-08-16
• Results First Submitted QC: 2016-11-17
• Status Verified: 2017-01
• Results First Posted: 2017-01-13
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 341

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination Product	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 tablets	Paracetamol (500 mg) tablets	Paracetamol (500 mg) tablets

Primary Outcome Measures

Name	Time	Method
Physician Global Evaluation of Effectiveness on Nasal Symptoms	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

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

Trial Locations

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

: Lal Clinica Centro de Pesquisa e Desenvolvimento Ltda, Rua General Osório, 503, Vila Martina / Valinhos; 🇧🇷 São Paulo, 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