Common cold and flu MedDRA version: 12.1 Level: LLT Classification code 10010106 Term: Common cold
Conditions
Interventions
Trade Name: Panodil Hot
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: PARACETAMOL
CAS Number: 103-90-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
GlaxoSmithKline Consumer Healthcare (GSKCH)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age Aged at least 18 years. 2. Consent Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. 3. Diagnosis at screening a.Present no more than 120 hours ( 5 days) since first symptoms of common cold occur. b.Have a self-rating of at least ‘moderate’ for nasal congestion at screening visit and a minimum of '2' on at least two of the VRS scales' (one of which must be blocked nose). c.Have at least 4 symptoms associated with the common cold and flu 4. Compliance Understands and is willing, able and likely to comply with all study procedures and restrictions. 5. General Health Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination. 6. Contraception Females of childbearing potential who are in the opinion of the investigator, practising a reliable method of contraception. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnancy Women who are known to be pregnant, or who have a positive pregnancy test. 2. Breast-feeding Women who are breast- feeding. 3. Disease a)Have a history of perennial allergic rhinitis or other chronic respiratory disease that (in the opinion of the investigator) is clinically significant. b)Have a history of psychiatric illness (including psychiatric and neurological conditions) that may affect assessments. 4. Medications a.Have used any medication to treat their cold (antibiotics in the last 7 days, antihistamine in the last 72 hours, analgesics or antipyretics in the last 24 hours, decongestant in the last 12 hours, antitussive, medicated lozenge or throat spray in the last 8 hours) prior to screening. b.Have taken any menthol containing product in the 2 hours before screening 5.Alcohol Have consumed alcohol in the last 6 hours prior to screening. 6. Allergy/Intolerance Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. 7. Clinical Study/Experimental Medication a)Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit. b)Previous treatment in this study. 8. Personnel An employee of the sponsor or the study site or members of their immediate family.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To subjectively assess the feeling of breathing in people suffering from the common cold over a 15 minute period, following a dose of a mentholated paracetamol hot drink compared to baseline.;Secondary Objective: To subjectively assess the feeling of breathing in people suffering from the common cold over a 15 minute period, following a dose of a mentholated paracetamol hot drink compared to a single dose of paracetamol. To subjectively assess the feeling of breathing in people suffering from the common cold over a 60 minute period, following a dose of a mentholated paracetamol hot drink compared to baseline and to a single dose of paracetamol. To subjectively assess the relief of symptoms of common cold other than breathing difficulty in people suffering from the common cold over a 15 and 60 minute period, following a dose of a mentholated paracetamol hot drink compared to baseline and to a single dose of paracetamol. ;Primary end point(s): The following statements will be presented: 1. My breathing feels easy 2. My head feels clear 3. I feel my airways are open 4. I feel soothing in my throat 5. I feel a cooling sensation in my nose 6. I feel my cough is being soothed 7. I can feel the air flowing to my lungs easily 8. My nose feels less blocked 9. I feel my breathing is comfortable 10. The hot drink is soothing (post drink only) 11. Overall, my cold symptoms are improved (post drink only) Each statement will be followed by the 5 point (0-4) rating scale with ‘0’ being labeled as ‘strongly disagree’ and ‘4’ being labeled as ‘strongly agree’. | — |
Countries
United Kingdom
Outcome results
None listed