To assess the subjective effect of two paracetamol preparations on the feeling of breathing in subjects with the common cold.

GlaxoSmithKline Consumer Healthcare (GSKCH)0 个研究点开始时间: 2010年8月18日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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
•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.

发起方

GlaxoSmithKline Consumer Healthcare (GSKCH)