NCT01448057

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 341 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2011-10-07
• Last updated: 2017-03-03
• Results posted: 2017-01-13

Locations

6 sites across 1 country: Brazil