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)

NCT01576809 | Completed Phase 3 Results

• 1 other identifier: 147-A-302
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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. 1.mild to moderate body pain, headache, fever or sore throat
2. 2.nasal congestion (blocked nose) with or without rhinorrhea (runny nose) or sneezing
3. 3.productive cough Adolescents will be included in the study population

Conditions

Upper Respiratory Infections

Keywords

Paracetamol; acetaminophen; phenylephrine; guaifenesin; syrup; URTI; productive cough

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Subject Acceptability of the Syrup

  1 hour

• Safety and Tolerability of the Syrup

  1 hour

Study Arms (1)

Upper Respiratory Tract Infection

EXPERIMENTAL

Drug: IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin

Interventions

IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin DRUG

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

Upper Respiratory Tract Infection

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead
• Novartis Consumer Health: collaborator

Study Sites (1)

Algorithme Pharma

Montreal, Quebec, H3P3P1, Canada

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Acetaminophen; Phenylephrine; Guaifenesin

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Guaiacol; Methyl Ethers; Ethers; Phenyl Ethers; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Clinical project Leader
• Organization: Novartis Consumer Health

41223633111

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: April 12, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: November 11, 2013
• Results First Posted: November 11, 2013

Record last verified: 2013-10

Locations

CA (1)