NCT01586962

Warming Sensation Intensity and Acceptability of the Flavour, Local Tolerability of Paracetamol 500 mg + Pseudoephedrine 30 mg Syrup in Patients Suffering a URTI

An Open Label, In-use Study to Assess the Warming Sensation, Acceptability and Local Tolerability of Paracetamol 500 mg + Pseudoephedrine 30 mg Syrup Given as a 30 ml Single Dose in Subjects Suffering From Symptoms of an Upper Respiratory Tract Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, in-use study to assess the warming sensation, acceptability and local tolerability of paracetamol 500 mg + pseudoephedrine 30 mg syrup, given as a single dose in subjects suffering from symptoms of an upper respiratory tract infection. The purpose is to evaluate the acceptability concerning a warming sensation effect and its potential benefit in the target population. The primary objective is to assess the warming sensation caused by the excipient IFF flavor 316 282, in a syrup containing paracetamol 500 mg + pseudoephedrine 30 mg per 30 ml syrup. The syrup contains (0.15% w/v) warming flavor. The Secondary Objectives are to assess subject acceptability of the syrup and the safety and tolerability of the syrup. The study will be run in fifty-six (56) subjects suffering from symptoms of an upper respiratory tract infection (URTI) for 7 days or less, e.g. nasal congestion associated with colds and flu symptoms such as pain, headache and/or fever. Subjects must have one or more symptoms per category: 1. mild to moderate body pain, headache, fever or sore throat 2. nasal congestion (blocked nose) with or without rhinorrhea (runny nose) or sneezing Adolescents will be included in the study population

Conditions

• Upper Respiratory Infections

Interventions

Type	Name	Description
DRUG	IFF flavor 316 282, Paracetamol, Pseudoephedrine	Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2012-04-27
• Last updated: 2013-08-07
• Results posted: 2013-08-07

Locations

1 site across 1 country: Canada