Warming Sensation Intensity and Acceptability of the Flavour, Local Tolerability of Paracetamol 500 mg + Pseudoephedrine 30 mg Syrup in Patients Suffering a URTI
Study Details
Study Description
Brief Summary
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 |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
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 [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
Secondary Outcome Measures
- Subject Acceptability of the Syrup [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 [1 hour]
Number of participants with adverse events.
Eligibility Criteria
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:
-
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)
-
Subject has a productive cough.
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Algorithme Pharma | Montreal | Quebec | Canada |
Sponsors and Collaborators
- Novartis
- Novartis Consumer Health
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 147-A-301
Study Results
Participant Flow
| Recruitment Details | Study Start/End Dates 07 May 2012 to 17 May 2012 |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Upper Respiratory Infections |
|---|---|
| Arm/Group Description | IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine |
| Period Title: Overall Study | |
| STARTED | 56 |
| COMPLETED | 56 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Upper Respiratory Infections |
|---|---|
| Arm/Group Description | IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine |
| Overall Participants | 56 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
56
100%
|
| >=65 years |
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
32.8
(12.61)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
31
55.4%
|
| Male |
25
44.6%
|
| Region of Enrollment (participants) [Number] | |
| Canada |
56
100%
|
Outcome Measures
| Title | Warming Sensation Caused by the Excipient IFF Flavor 316 282, in a Syrup Containing Paracetamol 500 mg + Pseudoephedrine 30 mg Per 30 ml Syrup |
|---|---|
| Description | Intensity of warming sensation felt by subjects between predose to 1 minute postdose where 0 = no warming sensation and 100 = strongest possible warming sensation |
| Time Frame | 1 minute |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Upper Respiratory Infections |
|---|---|
| Arm/Group Description | IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine |
| Measure Participants | 56 |
| Mean (Standard Deviation) [mm] |
34.2
(25.51)
|
| Title | Subject Acceptability of the Syrup |
|---|---|
| Description | 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 |
| Time Frame | 1 hour |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Upper Respiratory Infections |
|---|---|
| Arm/Group Description | IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine |
| Measure Participants | 56 |
| Number [Participants] |
39
69.6%
|
| Title | Safety and Tolerability of the Syrup |
|---|---|
| Description | Number of participants with adverse events. |
| Time Frame | 1 hour |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Upper Respiratory Infections |
|---|---|
| Arm/Group Description | IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine |
| Measure Participants | 56 |
| Number [Participants] |
9
16.1%
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Upper Respiratory Infections | |
| Arm/Group Description | IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine | |
All Cause Mortality |
||
| Upper Respiratory Infections | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Upper Respiratory Infections | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/56 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Upper Respiratory Infections | ||
| Affected / at Risk (%) | # Events | |
| Total | 4/56 (7.1%) | |
| Nervous system disorders | ||
| Somnolence | 4/56 (7.1%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Preliminary agreement between Novartis Consumer Health and the investigator
Results Point of Contact
| Name/Title | Clinical Project Leader |
|---|---|
| Organization | Novartis |
| Phone | +41223633111 |
- 147-A-301