Warming Sensation Intensity and Acceptability of the Flavour, Local Tolerability of Paracetamol 500 mg + Pseudoephedrine 30 mg Syrup in Patients Suffering a URTI

This study has been completed.
Sponsor:
Collaborator:
Novartis Consumer Health
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01586962
First received: April 23, 2012
Last updated: August 6, 2013
Last verified: April 2013
  Purpose

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:

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

Condition Intervention Phase
Upper Respiratory Infections
Drug: IFF flavor 316 282, Paracetamol, Pseudoephedrine
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ 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


Secondary Outcome Measures:
  • Subject Acceptability of the Syrup [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Number of participants with adverse events.


Enrollment: 56
Study Start Date: May 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must have one or more symptoms per category (see also screening assessment of cold symptoms, section 6.1):
  • mild to moderate body pain, headache, fever or sore throat
  • nasal congestion (blocked nose) with or without rhinorrhea (runny nose) or sneezing

Exclusion Criteria:

  1. 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)
  2. 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)
  3. Subject has a productive cough.
  4. History of hypersensitivity to any of the study drugs and the listed excipients or to drugs of similar chemical classes
  5. Subjects with allergic asthma.
  6. 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.
  7. Use of any medication for sore throat containing a local anaesthetic within the 6 hours prior to dosing.
  8. Use of paracetamol, any NSAID or any oral nasal decongestant within 6 hours prior to dosing.
  9. Use of substances of abuse or antihistamines within 24 hours of dosing.
  10. Drinking of tea, coffee or other caffeinated beverages 1 hour prior to dosing.
  11. 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.
  12. Use of any antidepressants, monoamine oxidase inhibitors or beta-blocking drugs in the 28 days prior to dosing
  13. 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.
  14. Subject is a current smoker of ≥10 cigarettes per day (or reports equivalent smoking habits using other tobacco products).
  15. Subject has smoked or chewed tobacco products within 12 hours of dosing.
  16. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01586962

Locations
Canada, Quebec
Algorithme Pharma
Montreal, Quebec, Canada
Sponsors and Collaborators
Novartis
Novartis Consumer Health
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01586962     History of Changes
Other Study ID Numbers: 147-A-301
Study First Received: April 23, 2012
Results First Received: April 25, 2013
Last Updated: August 6, 2013
Health Authority: Canada: Health Canada

Keywords provided by Novartis:
paracetamol
pseudoephedrine
syrup
upper respiratory tract infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Acetaminophen
Ephedrine
Pseudoephedrine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Central Nervous System Stimulants
Sympathomimetics
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014