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 not yet open for participant recruitment.

Verified March 2013 by Novartis

Sponsor:

Information provided by (Responsible Party):

Novartis

ClinicalTrials.gov Identifier:

NCT01448057

First received: October 5, 2011

Last updated: March 18, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 5, 2011

Last Updated Date

March 18, 2013

Start Date ^ICMJE

April 2013

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Sum of subject self-assessments of intensity of individual nasal symptoms using 100 mm VAS [ Time Frame: up to 3 days ] [ Designated as safety issue: No ]

Subject will assess nasal symptoms using a 100 mm visual analog scale.

Change History

Complete list of historical versions of study NCT01448057 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Subject self-assessments using 100-mm VAS 2 hours after the 4th dose. [ Time Frame: up to 3 days ] [ Designated as safety issue: No ]

Subject to assess nasal symptoms using a 100 mm visual analog scale 2 hours after the 4th dose.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Upper Respiratory Tract Infection
Nasal Congestion
Rhinorrhea
Sneezing

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Arm A
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: Arm B
Paracetamol (500 mg) tablets

Intervention: Drug: Paracetamol (500 mg) tablets

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

244

Estimated Completion Date

January 2014

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Eric Guenin

9735037169

eric.guenin@novartis.com

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT01448057

Other Study ID Numbers ^ICMJE

381-A-301

Has Data Monitoring Committee

Responsible Party

Novartis

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Novartis

Verification Date

March 2013

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

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