To assess the subjective effect of two paracetamol preparations on the feeling of breathing in subjects with the common cold.
- Conditions
- Common cold and fluMedDRA version: 12.1Level: LLTClassification code 10010106Term: Common cold
- Registration Number
- EUCTR2010-021798-34-GB
- Lead Sponsor
- GlaxoSmithKline Consumer Healthcare (GSKCH)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method