Warming Sensation Intensity and Acceptability of the Flavour, Local Tolerability of Paracetamol 500 mg + Phenylephrine 10mg + Guaifenesin 200 mg Syrup in Patients Suffering a Upper Respiratory Tract Infection (URTI)
This is an open label, in-use study to assess the warming sensation, acceptability and local tolerability of paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 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 + phenylephrine 10mg + Guaifenesin 200 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:
- mild to moderate body pain, headache, fever or sore throat
- nasal congestion (blocked nose) with or without rhinorrhea (runny nose) or sneezing
- productive cough Adolescents will be included in the study population
|Upper Respiratory Infections||Drug: IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin||Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
|Official Title:||An Open Label, In-use Study to Assess the Warming Sensation, Acceptability and Local Tolerability of Paracetamol 500 mg + Phenylephrine 10mg + Guaifenesin 200 mg Syrup Given as a 30 ml Single Dose in Subjects Suffering From Symptoms of an Upper Respiratory Tract Infection|
- Warming Sensation Caused by the Excipient IFF Flavor 316 282, in a Syrup Containing Paracetamol 500 mg + Phenylephrine 10mg + Guaifenesin 200 mg Per 30 ml Syrup [ Time Frame: 1 minutes ]Intensity of warming sensation felt by subjects between predose to 1 minute postdose where 0= no warming sensation and 100= strongest possible warming sensation
- Subject Acceptability of the Syrup [ Time Frame: 1 hour ]
In response to the question "How did you like the warming sensation you have experienced for this product?", the number of patients answering "Like extremely or Like very much or Like moderately or Like slightly"
Possible responses are :
Like extremely Like very much Like moderately Like slightly Neither like nor dislike Dislike slightly Dislike moderately Dislike very much Dislike extremely
- Safety and Tolerability of the Syrup [ Time Frame: 1 hour ]Number of participants with adverse events.
|Study Start Date:||March 2012|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
|Experimental: Upper Respiratory Tract Infection||
Drug: IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin
Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup
Please refer to this study by its ClinicalTrials.gov identifier: NCT01576809
|Montreal, Quebec, Canada, H3P3P1|