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
| ISRCTN | ISRCTN65790556 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65790556 |
| Secondary identifying numbers | 701004.01.012 |
- Submission date
- 02/12/2010
- Registration date
- 10/01/2011
- Last edited
- 18/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Fathi Abdul Malek
Scientific
Scientific
Dr. Willmar Schwabe GmbH & Co. KG
Clinical Research Department
Willmar-Schwabe-Str. 4
Karlsruhe
76227
Germany
Study information
| Study design | Prospective multicentre single-arm open-label phase IV safety study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a copy of subject information form |
| Scientific title | EPs® 7630 film-coated tablets in subjects (greater than or equal to 18 years old) suffering from common cold: a prospective, multicentre, single-arm, open-label, phase IV clinical post-marketing safety study |
| Study objectives | The objective of the present post-marketing study is to gain further information about the safety and treatment outcome with EPs® 7630 film-coated tablets (Kaloba 20 mg Filmtabletten) in adult subjects (greater than or equal to 18 years old) suffering from common cold. Please note that as of 18/09/2012, the anticipated end date of this trial has been updated from 31/12/2011 to 31/12/2013. |
| Ethics approval(s) | Ethikkommissionder Medizinischen Universität Graz approved on the 16th December 2010 (ref: 23-076e x 10/11) |
| Health condition(s) or problem(s) studied | Common cold |
| Intervention | One EPs® 7630 film-coated tablet (Kaloba 20 mg Filmtabletten) three times a day for a period of 10 consecutive days. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | EPs® 7630 |
| Primary outcome measure | 1. Adverse events surveillance 2. Treatment outcome according to the Integrative Medicine Outcomes Scale (IMOS) as assessed by the investigator (day 3, 5 and 10) and the subject (visit 2 and 3), respectively 3. Change in individual common cold symptoms (CCS) and total score of CCS from baseline (day 1) to visit 2 and visit 3, respectively, as assessed by the investigator 4. Change in further common cold relevant complaints from baseline (day 1) to visit 2 and visit 3, respectively, as assessed by the investigator 5. Change in total score of common cold symptoms and further common cold relevant complaints from baseline (day 1) to visit 2 and visit 3, respectively, as assessed by the investigator 6. Change in common cold symptoms (CCS) as rated by the subject in the subject's diary 7. Number of subjects who are 'not sick' or 'very mildly sick' as rated daily by the subject in the subject's diary when answering the question 'how sick do you feel today?' 8. Duration of subject's off work or inability to attend school/college (checked daily) 9. Need for subject's treatment with antibiotics during the study period according to the medical decision of the investigator 10. Use of paracetamol tablets from baseline (day 1) to individual study end 11. Satisfaction of the subject with the treatment according to the Integrative Medicine Patient Satisfaction Scale (IMPSS) as assessed by the subject in the subject's diary at day 10 |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 10/01/2011 |
| Completion date | 31/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 subjects |
| Total final enrolment | 120 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/01/2011 |
| Date of final enrolment | 31/12/2013 |
Locations
Countries of recruitment
- Austria
- Germany
Study participating centre
Dr. Willmar Schwabe GmbH & Co. KG
Karlsruhe
76227
Germany
76227
Germany
Sponsor information
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Industry
Industry
c/o F. A. Malek, MD, PhD
Clinical Research Department
Willmar-Schwabe-Str. 4
Karlsruhe
76227
Germany
| Website | http://www.schwabepharma.com/international/ |
|---|---|
"ROR" |
https://ror.org/043rrkc78 |
Funders
Funder type
Industry
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 30/04/2021 | 18/05/2021 | Yes | No |
Editorial Notes
18/05/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
