EPs® 7630 film-coated tablets in subjects (=18 years old) suffering from common coldA prospective safety study of an already marketed product without comparison to a comparator performed in many study sites
- Conditions
- Common coldMedDRA version: 14.0Level: LLTClassification code 10010106Term: Common coldSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
- Registration Number
- EUCTR2010-022441-21-AT
- Lead Sponsor
- Dr. Willmar Schwabe GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(1)Male and female subjects older or equal than 18 years old
(2)Written informed consent
(3)Subject suffers from common cold
(4)Presence of at least two common cold symptoms
(5)First common cold symptom started = 72 hours prior to inclusion into the study
(6)Subject with willingness and ability to comply with all procedures of the trial.
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)Obstructive anatomic lesions in the nasopharynx such as nasal polyps, or severe septal deviations
(2)Previous surgery (within the last 12 months prior to inclusion into the study) or need for surgery of the nose or paranasal sinuses incl. sinus puncture
(3)Presence of any acute respiratory tract disease (e.g. tonsillitis, sinusitis, otitis media, bronchitis, pneumonia) other than common cold
(4)Subjects with known or suspected allergic rhinitis
(5)Subjects with other explanations of sore throat (e.g. tonsillo-pharyngitis, drugs, aphthous ulcers, candida, etc.)
(6)Subjects with previous rheumatic fever within the last 12 months prior to inclusion into the trial
(7)Subjects with several previous complications of tonsillitis (quinsy)
(8)Chronic lung diseases (e.g. chronic bronchitis, COPD, bronchial asthma, cystic fibrosis, active pulmonary tuberculosis, lung cancer)
(9)History of recurrent tonsillitis or otitis media of > 3 episodes during the last 12 months prior to enrolment into the study
(10)History of recurrent bronchitis of > 6 episodes during the past 12 months prior to enrolment into the study
(11)History of recurrent sinusitis of > 3 episodes during the past 12 months prior to enrolment into the trial or chronic sinusitis (symptoms lasting for > 1 month)
(12)Previous (within the last 6 weeks prior to inclusion into the clinical trial) or concomitant treatment with anti-coagulants
(13)Concomitant common cold medications that might impair the interpretation of trial results
(14)Known or suspected hypersensitivity to the investigational drug
(15)Severe cardiovascular disease, unstable diabetes mellitus, or immunosuppression
(16)History of renal or hepatic dysfunction (serum creatinine, serum AST, ALT or alkaline phosphatase of >3 times above the upper limit of normal values) at any time during the past 12 months prior to enrolment into the trial
(17)Known alcohol or drug abuse
(18)Subjects with tendency to bleed, especially nose or gingival bleeding
(19)Known gastrointestinal disorders (e.g. gastritis, duodenitis, colitis, gastric ulcer, partial or total gastrectomy, enterectomy, inflammatory bowel disease, celiac disease, symptomatic lactose intolerance, other disorders associated with chronic diarrhea)
(20)Females of child-bearing potential without adequate contraception
(21)Pregnancy or lactation
(22)Subjects participating in another clinical trial at the same time or have taken part in a clinical trial during the last 4 weeks before inclusion into this study
(23)Irresponsible subjects or those unable to understand nature, meaning and consequences of the trial
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