Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004977-28 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the study is to evaluate the safety of the intake of EPs® 7630 during a long-term (4 months) medication. The protective effects of EPs®7630 and its effects during a cold episode will also be studied.
The main objective of this clinical trial is to evaluate the safety of EPsĀ® 7630 intake - used as continuous protection and at the onset of cold symptoms - in adult participants during a long-term (4 months) medication. Due to the sparseness of empirical data in the population and this setting, no confirmatory hypotheses are formulated and the data will be analysed descriptively.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EPsĀ® 7630 | Active Comparator | Active Comparator 20 mg EPsĀ® 7630 film-coated tablet
|
|
| EPs(R) 7630 | Active Comparator | Active Comparator 20 mg EPsĀ® 7630 film-coated tablet
|
|
| Placebo | Placebo Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPsĀ® 7630 | Drug | 20 mg EPsĀ® 7630 film-coated tablets during 4 months Orally intake three times a day (in the morning, midday and evening) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Adverse Drug Reactions (ADRs) | during the 4 months treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Adverse Events (AEs) during the 4 months treatment | Adverse events will be documented during the 4 months treatment period. | |
| Protective effects | Time to onset of first common cold symptoms, time between last common cold episode prior to trial entry and first cold episode during the trial, total number of common cold episodes, total number of participants with at least one / more than one common cold episode |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Chronic respiratory tract or lung disease (e.g. chronic bronchitis, COPD, bronchial asthma, cystic fibrosis, active pulmonary tuberculosis, lung cancer)
History of heart, renal, liver, neuromuscular disease and/or immunosuppression
Known allergic bronchial asthma
Known or suspected congenital anomalies of heart, kidney, liver, or mental disabilities
Participant with concomitant medications that might impair the interpretation of trial results (e.g. herbal medications for common cold other than the investigational product, or pain relief medications other than Paracetamol or Ibuprofen)
Women of child-bearing potential with no adequate and effective contraception (MHRA, 2010):
Female participant who is pregnant, lactating or planning pregnancy during the course of the clinical trial
Participant with cold symptoms at inclusion
Current intake of antimicrobial and/or antiviral medication for any reason
Participant with known or suspected history of alcohol or drug abuse
Heavy smoking (more than 10 cigarettes per day)
Psychiatric disorders which may influence the results of the trial, epilepsy, or suicide attempts
Planned surgical intervention during the trial
Known gastrointestinal disorders with uncertain absorption of orally administered medication (e.g. partial or total gastrectomy, enterectomy, inflammatory bowel disease, celiac disease, symptomatic lactose intolerance, dysbacteriosis) or associated with diarrhoea
Known or suspected hypersensitivity to the active substance or to any of the excipients of the investigational product
Known clinically relevant laboratory abnormalities
Participant with increased tendency to bleed, especially nasal or gingival bleeding
Previous (within the last 3 months prior to visit 1) or concomitant treatment with coagulation-inhibiting drugs such as warfarin
Participation in a further clinical trial at the same time or within the last 4 weeks prior to inclusion into the present study
Previous randomisation in the present clinical study
Irresponsible subjects or those unable to understand nature, meaning and consequences of the trial
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Moutaz SM Jawad, M.B., B.Ch., FRCP | Common Cold Centre, Cardiff School of Biosciences, Cardiff University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiff University, Common Cold Centre, Cardiff School of Biosciences | Cardiff | Wales | United Kingdom |
Not provided
| ID | Term |
|---|---|
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D003890 | Desiccation |
| ID | Term |
|---|---|
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D055598 | Chemical Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Control: Placebo film coated tablets during 4 months Orally intake three times a day (in the morning, midday and evening) |
|
| Protective effects will be evaluated during the 4 months treatment period. |
| Effects during a cold episode | Mean cold episode duration (in days), cumulative episode days, number of co-medicated cold episodes, number of patients with respiratory complications due to common cold, development of the total cold symptom score and of single symptoms during a cold episode | Treatment effects on common cold symptoms will be documented for 14 days after onset of first common cold symptom |
| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |