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

NCT01448057 | Completed Phase 3 Results

• 1 other identifier: 381-A-301
• Study Type: interventional
• Target: 341
• Locations: 1 country
• Sites: 6

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).

Conditions

Upper Respiratory Tract Infection; Nasal Congestion; Rhinorrhea; Sneezing

Keywords

Paracetamol; dimethindene maleate; phenylephrine hydrochloride; cold and flu symptoms

Outcome Measures

Primary Outcomes (1)

• 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

  Day 2

Secondary Outcomes (1)

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

  Day 3

Study Arms (2)

Combination Product

EXPERIMENTAL

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 tablets

ACTIVE COMPARATOR

Paracetamol (500 mg) tablets

Drug: Paracetamol (500 mg) tablets

Interventions

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

Combination Product

Paracetamol (500 mg) tablets DRUG

Paracetamol (500 mg) tablets

Paracetamol tablets

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead

Study Sites (6)

Santa Casa De Misericordia De Belo Horizonte - Avenida Francisco Sales 1111, Santa Efigenia

Belo Horizonte/MG, 30150-221, Brazil

Location

Sociedade Campineira De Educacao E Instrucao - Rodovia Dom Pedro I, KM 136 Parque das Universidades

Campinas/SP, Brazil

Location

Instituto de Ensino e Pesquisa Clínica do Ceará, Rua Coronel Jucá, 1952 - Dionísio Torres -

Fortaleza/CE, 60170-320, Brazil

Location

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, 17210-070, Brazil

Location

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

São Paulo, 13271-130, Brazil

Location

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

São Paulo, Brazil

Location

MeSH Terms

Conditions

Respiratory Tract Infections; Nasal Obstruction; Rhinorrhea; Sneezing; Common Cold

Interventions

Acetaminophen; Dimethindene; Phenylephrine

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Nose Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Picornaviridae Infections; RNA Virus Infections; Virus Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols

Results Point of Contact

• Title: Director Clinical research Respiratory
• Organization: Novartis consumer Health a GSK Consumer Healtcare company

anna.x.grinienko@gsk.com

(1) 5512065988

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2011
• First Posted: October 7, 2011
• Study Start: July 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 3, 2017
• Results First Posted: January 13, 2017

Record last verified: 2017-01

Locations

BR (6)