To gain further information about the safety of EPs® 7630 film-coated tablets (Kaloba 20 mg Filmtabletten) in adult subjects (greater than or equal to 18 years old) suffering from common cold symptoms

Phase 4

Completed

• Conditions: Common cold; Respiratory

• Registration Number: ISRCTN65790556
• Lead Sponsor: Dr. Willmar Schwabe GmbH & Co. KG (Germany)

Brief Summary

2021 results in https://pubmed.ncbi.nlm.nih.gov/33995094/ (added 18/05/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-01-10
• Study Completion: 2013-12-31
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Male and female subjects aged greater than or equal to 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 less than or equal to 72 hours prior to inclusion into the study
6. Subject with willingness and ability to comply with all procedures of the trial

Exclusion Criteria

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 including 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 greater than 3 episodes during the last 12 months prior to enrolment into the study
10. History of recurrent bronchitis of greater than 6 episodes during the past 12 months prior to enrolment into the study
11. History of recurrent sinusitis of greater than 3 episodes during the past 12 months prior to enrolment into the trial or chronic sinusitis (symptoms lasting for greater than 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 aspartate aminotransferase [AST], alanine aminotransferase [ALT] or alkaline phosphatase of greater than 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, coeliac disease, symptomatic lactose intolerance, other disorders associated with chronic diarrhoea)
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
• Study Design: Not specified