Systemic and respiratory symptoms of Influenza-like-illness (ILI) MedDRA version: 14.1 Level: LLT Classification code 10016797 Term: Flu-like symptoms System Organ Class: 100000004867
Conditions
Interventions
Trade Name: Oscillococcinum Pillules
Product Name: Oscillococcinum Pillules
Pharmaceutical Form: Pillules
INN or Proposed INN: N/A
Current Sponsor code: Oscillococcinum
Other descriptive name: Anas ba
Sponsors
Boiron Laboratoires
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged = 12 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with active and clinically significant renal, cardiac, pulmonary, vascular, neurologic, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency disorders, cancer, hepatitis, cirrhosis, asthma or chronic obstructive pulmonary disease (COPD) 2. Participation in a clinical study with an investigational drug within 4 weeks prior to study entry 3. Patients who experienced a previous episode of acute upper respiratory tract infection (URTI), sinusitis, bronchitis, otitis or pneumonia within 2 weeks prior to study day 0 4. Patients taking steroids or immuno-suppressant therapies within 2 months prior to Study Day 0. 5. Participants with evidence/history of alcoholism, drug abuse, psychiatric disorders or any other medical condition that could affect the study completion or the collection of the data relevant for safety or efficacy 6. Patients with contraindications for paracetamol, e.g. liver insufficiency, severe renal insufficiency 7. Treatment within 2 weeks prior to the Initial Visit with neuraminidase inhibitors, adamantanes or within 1 week with Oscillococcinum® or antibiotics 8. Patients with a positive pharyngeal test for Group A streptococcus at inclusion 8. Patients with any other disease that requires immediate start of antibiotic treatment. 9. Pregnant or breast-feeding women. 10. Patients with intolerance of fructose, malabsorption of glucose or galactose, sucrase/isomaltase deficit 11. Any other condition which according to the investigator’s judgement is not compatible with the principles of the study, e.g. inability to give informed consent, inability to complete the diary
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of Oscillococcinum in the treatment of symptoms of ILI.;Secondary Objective: To evaluate the efficacy of Oscillococcinum in: -the reduction of symptoms duration -the reduction of symptoms severity -the improvement of patients’ quality of life -the development of secondary illnesses -the reduction of concomitant medication. To evaluate the patients' compliance regarding the use of Oscillococcinum To evaluate the tolerability of Oscillococcinum To evaluate the patients' and physicians' satisfaction regarding the efficacy and tolerability of Oscillococcinum ;Primary end point(s): The first primary evaluation criterion is the time to absence of systemic flu-like symptoms. Time to absence of systemic flu-like symptoms is defined as follows: Time from first intake of study medication to the first occurrence of - no fever (body temperature <37.8°C) AND - chills, headache, myalgia, and malaise recorded as ‘none’. Scores of ‘none’ for chills, headache, myalgia, malaise, and fever have to be maintained over 24 hours. Symptoms are assessed as none, mild, moderate, or severe. The assessment of symptoms is to be done 3 times daily and to be documented in a patient diary. If the difference between Oscillococcinum and placebo is statistically significant for the time to absence of systemic flu-like symptoms, the time to absence of systemic flu-like symptoms AND to alleviation of respiratory flu-like symptoms will be tested as a co-primary endpoint. Time to absence of systemic AND alleviation of respiratory flu-like symptoms is defined as follows: Time from first intake of study medication to the first occurrence of: - absence of systemic flu-like symptoms as defined above AND - alleviation of cough, sore throat and shortness of breath, defined as follows: - if recorded as ‘moderate’ or ‘severe’ at inclusion: recorded as ‘none’ or ‘mild’ - if recorded as ‘mild’ at inclusion: recorded as ‘none’ - scores of ‘none’ or ‘mild’ have to be | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To answer to the objective: evaluate efficacy on symptom duration: - Time to alleviate respiratory flu-like symptoms - Time to absence of systemic symptoms AND alleviation of respiratory flu-like symptoms as defined for the co-primary endpoint (if not tested as a co-primary endpoint) - Time to alleviate each symptom (all criteria of systemic flu-like symptoms plus all criteria of respiratory symptoms plus other symptoms (consisting of fatigue, nasal congestion and gastro-intestinal symptoms)).The definition of alleviation used for the respiratory symptoms for the co-primary endpoint is applied to all symptoms for this endpoint. -Time to absence of each symptom (all criteria of systemic flu-like symptoms plus all criteria of respiratory symptoms plus other symptoms (consisting of fatigue, nasal congestion and gastro-intestinal symptoms)). For absence, the definition applies that is used in the primary endpoint regarding absence of systemic symptoms. To answer to the objective: evaluate efficacy on symptoms severity: - Severity of symptoms after each dose of treatment in terms of total score for systemic flu-like symptoms and total score for respiratory flu-like symptoms. The total score for the systemic flu-like symptoms is the sum of the scores for each criterion of the systemic flu-like symptoms. The total score for the respiratory flu-like symptoms is the sum of the scores for each criterion of the respiratory flu-like symptoms. - Severity of each individual symptom after each dose of treatment -Proportion of patients with 50% reduction in total symptom score after each dose of treatment - Proportion of patients with 50% reduction in total score for systemic flu-like symptoms after each dose of treatment - Proportion of patients with 50% reduction in total score for respiratory flu-like symptoms after each dose of treatment - Severity of each individual symptom score after each dose of treatment - Proportion of patients with 50 | — |
Countries
Germany
Contacts
Public ContactStéphanie Villet -Research Projects
Boiron Laboratoires
Outcome results
None listed