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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01576809
Other study ID # 147-A-302
Secondary ID
Status Completed
Phase Phase 3
First received March 29, 2012
Last updated October 18, 2013
Start date March 2012
Est. completion date May 2012

Study information

Verified date October 2013
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label


Intervention

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

Locations

Country Name City State
Canada Algorithme Pharma Montreal Quebec

Sponsors (2)

Lead Sponsor Collaborator
Novartis Novartis Consumer Health

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Intensity of warming sensation felt by subjects between predose to 1 minute postdose where 0= no warming sensation and 100= strongest possible warming sensation 1 minutes No
Secondary Subject Acceptability of the Syrup 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
1 hour No
Secondary Safety and Tolerability of the Syrup Number of participants with adverse events. 1 hour No
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