Upper Respiratory Infections Clinical Trial
Official title:
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
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
n/a
Intervention Model: Single Group Assignment, Masking: Open Label
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