Warming Sensation Intensity and Acceptability of the Flavour, Local Tolerability of Paracetamol 500 mg + Pseudoephedrine 30 mg Syrup in Patients Suffering a URTI
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|ClinicalTrials.gov Identifier: NCT01586962|
Recruitment Status : Completed
First Posted : April 27, 2012
Results First Posted : August 7, 2013
Last Update Posted : August 7, 2013
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:
- mild to moderate body pain, headache, fever or sore throat
- nasal congestion (blocked nose) with or without rhinorrhea (runny nose) or sneezing Adolescents will be included in the study population
|Condition or disease||Intervention/treatment||Phase|
|Upper Respiratory Infections||Drug: IFF flavor 316 282, Paracetamol, Pseudoephedrine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|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 + Pseudoephedrine 30 mg Syrup Given as a 30 ml Single Dose in Subjects Suffering From Symptoms of an Upper Respiratory Tract Infection|
|Study Start Date :||May 2012|
|Primary Completion Date :||May 2012|
|Study Completion Date :||May 2012|
|Experimental: Upper Respiratory Infections||
Drug: IFF flavor 316 282, Paracetamol, Pseudoephedrine
Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
- Warming Sensation Caused by the Excipient IFF Flavor 316 282, in a Syrup Containing Paracetamol 500 mg + Pseudoephedrine 30 mg Per 30 ml Syrup [ Time Frame: 1 minute ]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 ]
How do you like the warming sensation you have experienced for this product?
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01586962
|Montreal, Quebec, Canada|