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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01448057
First Posted: October 7, 2011
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis
October 5, 2011
October 7, 2011
August 16, 2016
January 13, 2017
March 3, 2017
July 2013
August 2015   (Final data collection date for primary outcome measure)
Physician Global Evaluation of Effectiveness on Nasal Symptoms [ Time Frame: 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

Sum of subject self-assessments of intensity of individual nasal symptoms using 100 mm VAS [ Time Frame: up to 3 days ]
Subject will assess nasal symptoms using a 100 mm visual analog scale.
Complete list of historical versions of study NCT01448057 on ClinicalTrials.gov Archive Site
Daily Average of the Sum of a 100 mm Visual Analog Scale for All Symptoms [ Time Frame: 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
Subject self-assessments using 100-mm VAS 2 hours after the 4th dose. [ Time Frame: up to 3 days ]
Subject to assess nasal symptoms using a 100 mm visual analog scale 2 hours after the 4th dose.
Not Provided
Not Provided
 
Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu
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
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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
  • Upper Respiratory Tract Infection
  • Nasal Congestion
  • Rhinorrhea
  • Sneezing
  • 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
  • Drug: Paracetamol (500 mg) tablets
    Paracetamol (500 mg) tablets
  • Experimental: Combination Product
    Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
    Intervention: Drug: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
  • Active Comparator: Paracetamol tablets
    Paracetamol (500 mg) tablets
    Intervention: Drug: Paracetamol (500 mg) tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
341
August 2015
August 2015   (Final data collection date for primary outcome measure)
  • 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

Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01448057
381-A-301
No
Not Provided
Not Provided
Novartis
Novartis
Not Provided
Not Provided
Novartis
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP