Who is sponsoring NCT01448057?

NCT01448057 is sponsored by Novartis.

What condition does NCT01448057 study?

NCT01448057 studies Upper Respiratory Tract Infection, Nasal Congestion, Rhinorrhea, Sneezing.

Is NCT01448057 still recruiting?

NCT01448057 is currently completed. Last updated 18 January 2017.

Are results published for NCT01448057?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-01-18 · How we verify

NCT01448057

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 18 January 2017

What this trial tests

Phase 3 trial testing Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets in Upper Respiratory Tract Infection in 341 participants. Completed in 1 August 2015.

Timeline

1 July 2013

Primary endpoint
1 August 2015

1 August 2015

Quick facts

Lead sponsor	Novartis
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	341
Start date	1 July 2013
Primary completion	1 August 2015
Estimated completion	1 August 2015
Sites	6 locations across Brazil

Drugs / interventions tested

Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets — full drug profile →
Paracetamol (500 mg) tablets — full drug profile →

Conditions studied

Upper Respiratory Tract Infection — all drugs for Upper Respiratory Tract Infection →
Nasal Congestion — all drugs for Nasal Congestion →
Rhinorrhea — all drugs for Rhinorrhea →
Sneezing — all drugs for Sneezing →

Sponsor

Novartis — full company profile →

Who can join

Adults 18 to 65, any sex, with Upper Respiratory Tract Infection or Nasal Congestion. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Function and Role of Histamine H<sub>1</sub> Receptor in the Mammalian Heart.
Neumann J, Hofmann B, Kirchhefer U, Dhein S, et al · · 2023 · cited 12× · PMID 37242517 · DOI 10.3390/ph16050734

Verify or expand the search:

Other Novartis trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01448057 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis
Last refreshed: 18 January 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01448057.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing