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 study has been completed.
Sponsor:
Collaborator:
Novartis Consumer Health
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01576809
First received: March 29, 2012
Last updated: October 18, 2013
Last verified: October 2013

March 29, 2012
October 18, 2013
March 2012
May 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Intensity of warming sensation felt by subjects between predose to 1 minute postdose where 0= no warming sensation and 100= strongest possible warming sensation
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: 10 minutes ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01576809 on ClinicalTrials.gov Archive Site
  • Subject Acceptability of the Syrup [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Number of participants with adverse events.
  • Subject acceptability of the syrup [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • Safety and tolerability of the syrup [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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)
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

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:

  1. mild to moderate body pain, headache, fever or sore throat
  2. nasal congestion (blocked nose) with or without rhinorrhea (runny nose) or sneezing
  3. productive cough Adolescents will be included in the study population
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: Open Label
Upper Respiratory Infections
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
Experimental: Upper Respiratory Tract Infection
Intervention: Drug: IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
May 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject 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
    • A productive cough

Exclusion Criteria:

  • Baseline sore throat pain of severe intensity, e.g. rated as 3 on a 4-point ordinal scale (0=not present, 1= mild, 2=moderate, 3=severe)
  • Baseline dry cough of severe intensity, e.g. rated as 3 on a 4-point ordinal scale (0=not present, 1= mild, 2=moderate, 3=severe)
  • History of hypersensitivity to any of the study drugs and the listed excipients or to drugs of similar chemical classes
  • Subjects with allergic asthma.
  • Use of any inhaler, medicated confectionary, throat lozenges, throat pastilles, sprays, any products with demulcent properties such as chewing gums and boiled sweets or mints, in the 6 hours prior to dosing.
  • Use of any medication for sore throat containing a local anaesthetic within the 6 hours prior to dosing.
  • Use of paracetamol, any NSAID or any oral nasal decongestant within 6 hours prior to dosing.
  • Use of substances of abuse or antihistamines within 24 hours of dosing.
  • Drinking of tea, coffee or other caffeinated beverages 1 hour prior to dosing.
  • Suffering from hepatic or severe renal impairment, hypertension, hyperthyroidism, diabetes, heart disease or other acute or chronic medical condition that, in the opinion of the investigator, would put the subject at a higher risk or affect the conduct and/or the results of the study.
  • Use of any antidepressants, monoamine oxidase inhibitors or beta-blocking drugs in the 28 days prior to dosing
  • A history of alcohol abuse or subject admits to regular consumption of alcohol in excess of the recommended weekly limits of 21 units for females and 28 units for males.
  • Subject is a current smoker of ≥10 cigarettes per day (or reports equivalent smoking habits using other tobacco products).
  • Subject has smoked or chewed tobacco products within 12 hours of dosing.
  • History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01576809
147-A-302
No
Novartis
Novartis
Novartis Consumer Health
Not Provided
Novartis
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP