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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

Primary Purpose

Upper Respiratory Tract Infection, Nasal Congestion, Rhinorrhea

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
Paracetamol (500 mg) tablets
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Upper Respiratory Tract Infection focused on measuring Paracetamol, dimethindene maleate, phenylephrine hydrochloride, cold and flu symptoms

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

  • 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

Sites / Locations

  • Santa Casa De Misericordia De Belo Horizonte - Avenida Francisco Sales 1111, Santa Efigenia
  • Sociedade Campineira De Educacao E Instrucao - Rodovia Dom Pedro I, KM 136 Parque das Universidades
  • Instituto de Ensino e Pesquisa Clínica do Ceará, Rua Coronel Jucá, 1952 - Dionísio Torres -
  • 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
  • Associacao Fundo De Incentivo A Pesquisa - AFIP - Rua Marselhesa 500 - Vila Clementino
  • : Lal Clinica Centro de Pesquisa e Desenvolvimento Ltda, Rua General Osório, 503, Vila Martina / Valinhos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combination Product

Paracetamol tablets

Arm Description

Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets

Paracetamol (500 mg) tablets

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 5, 2011
Last Updated
January 18, 2017
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01448057
Brief Title
Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu
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 Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infection, Nasal Congestion, Rhinorrhea, Sneezing
Keywords
Paracetamol, dimethindene maleate, phenylephrine hydrochloride, cold and flu symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
341 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combination Product
Arm Type
Experimental
Arm Description
Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
Arm Title
Paracetamol tablets
Arm Type
Active Comparator
Arm Description
Paracetamol (500 mg) tablets
Intervention Type
Drug
Intervention Name(s)
Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
Intervention Description
Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
Intervention Type
Drug
Intervention Name(s)
Paracetamol (500 mg) tablets
Intervention Description
Paracetamol (500 mg) tablets
Primary Outcome Measure Information:
Title
Physician Global Evaluation of Effectiveness on Nasal Symptoms
Description
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 Outcome Measure Information:
Title
Daily Average of the Sum of a 100 mm Visual Analog Scale for All Symptoms
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Santa Casa De Misericordia De Belo Horizonte - Avenida Francisco Sales 1111, Santa Efigenia
City
Belo Horizonte/MG
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
Sociedade Campineira De Educacao E Instrucao - Rodovia Dom Pedro I, KM 136 Parque das Universidades
City
Campinas/SP
Country
Brazil
Facility Name
Instituto de Ensino e Pesquisa Clínica do Ceará, Rua Coronel Jucá, 1952 - Dionísio Torres -
City
Fortaleza/CE
ZIP/Postal Code
60170-320
Country
Brazil
Facility Name
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
City
Jau/SP
ZIP/Postal Code
17210-070
Country
Brazil
Facility Name
Associacao Fundo De Incentivo A Pesquisa - AFIP - Rua Marselhesa 500 - Vila Clementino
City
Sao Paulo
Country
Brazil
Facility Name
: Lal Clinica Centro de Pesquisa e Desenvolvimento Ltda, Rua General Osório, 503, Vila Martina / Valinhos
City
São Paulo
ZIP/Postal Code
13271-130
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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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