Condition category
Respiratory
Date applied
02/12/2010
Date assigned
10/01/2011
Last edited
18/09/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Fathi Abdul Malek

ORCID ID

Contact details

Dr. Willmar Schwabe GmbH & Co. KG
Clinical Research Department
Willmar-Schwabe-Str. 4
Karlsruhe
76227
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

701004.01.012

Study information

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

Acronym

Study hypothesis

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

Ethikkommissionder Medizinischen Universität Graz approved on the 16th December 2010 (ref: 23-076e x 10/11)

Study design

Prospective multicentre single-arm open-label phase IV safety study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a copy of subject information form

Condition

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

Phase

Phase IV

Drug names

EPs® 7630

Primary outcome measures

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 trial start date

10/01/2011

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120 subjects

Participant 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

Recruitment start date

10/01/2011

Recruitment end date

31/12/2013

Locations

Countries of recruitment

Austria

Trial participating centre

Dr. Willmar Schwabe GmbH & Co. KG
Karlsruhe
76227
Germany

Sponsor information

Organisation

Dr. Willmar Schwabe GmbH & Co. KG (Germany)

Sponsor details

c/o F. A. Malek
MD
PhD
Clinical Research Department
Willmar-Schwabe-Str. 4
Karlsruhe
76227
Germany

Sponsor type

Industry

Website

http://www.schwabepharma.com/international/

Funders

Funder type

Industry

Funder name

Dr. Willmar Schwabe GmbH & Co. KG (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes