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

This study is currently recruiting participants.
Verified April 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01448057
First received: October 5, 2011
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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).


Condition Intervention Phase
Upper Respiratory Tract Infection
Nasal Congestion
Rhinorrhea
Sneezing
Drug: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
Drug: Paracetamol (500 mg) tablets
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Physician Global evaluation of effectiveness on Nasal Symptoms [ Time Frame: up to 3 days ] [ Designated as safety issue: No ]
    The Physician will measure the reduction of Nasal Symptoms (Nasal Congestion, Sneezing, and Rhinorrhea) on day 2


Secondary Outcome Measures:
  • Sum of subject self assessment using a 100 mm Visual Analog Scale [ Time Frame: up to 3 days ] [ Designated as safety issue: No ]
    Subject will assess Nasal Symptoms using a 100 mm Visual Analog Scale


Estimated Enrollment: 244
Study Start Date: July 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
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 (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
Active Comparator: Arm B
Paracetamol (500 mg) tablets
Drug: Paracetamol (500 mg) tablets
Paracetamol (500 mg) tablets

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448057

Contacts
Contact: Eric Guenin 9735037169 eric.guenin@novartis.com

Locations
Brazil
Instituto de Ensino e Pesquisa Clínica do Ceará, Rua Coronel Jucá, 1952 - Dionísio Torres - Recruiting
Fortaleza/CE, Brazil, 60170-320
Contact    +55 85 3257 9646      
Hospital Sao Lucas da PUCRS , Ave. Ipiranga 6690 Recruiting
Porto Alegre/RS, Brazil, 90610-000
Contact    +55 51 3384 1732      
: Lal Clinica Pesquisa, Rua General Osório, 507, Vila Martina / Valinhos Recruiting
São Paulo, Brazil, 13270000
Contact    55 19 3829 6160      
Sponsors and Collaborators
Novartis
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01448057     History of Changes
Other Study ID Numbers: 381-A-301
Study First Received: October 5, 2011
Last Updated: April 2, 2014
Health Authority: Brazil: Agência Nacional de Vigilância Sanitária do Ministério da Saúde do Brasil - ANVISA/MS

Keywords provided by Novartis:
Paracetamol
dimethindene maleate
phenylephrine hydrochloride
cold and flu symptoms

Additional relevant MeSH terms:
Respiratory Tract Infections
Sneezing
Infection
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Acetaminophen
Phenylephrine
Oxymetazoline
Dimethindene
Maleic acid
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Enzyme Inhibitors
Adrenergic alpha-1 Receptor Agonists

ClinicalTrials.gov processed this record on April 20, 2014