A clinical study to assess the efficacy and safety of Oscillococcinum® in the treatment of symptoms of influenza-like illness (ILI), when compared with placebo (a sugar pill without oscillococcinum). The study treatment is given in a randomised, parallel group, double-blind (neither patient or doctor aware of which treatment they have) manner, in several study centres.

• Conditions: Systemic and respiratory symptoms of Influenza-like-illness (ILI); MedDRA version: 14.1Level: LLTClassification code 10016797Term: Flu-like symptomsSystem Organ Class: 100000004867; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2013-001869-16-DE
• Lead Sponsor: Boiron Laboratoires

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-03
• Last Update Posted: 16 November 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Aged = 12 and < 65 years of age.
2. Patients with ILI defined as sudden onset of symptoms and at least one of the following systemic symptoms: fever (=37.8°C) or chills, headache, myalgia, malaise (= assessment mild, moderate or severe for at least one of these symptoms) and at least one of the following respiratory symptom: cough, sore throat, shortness of breath (= assessment mild, moderate or severe for at least one of these symptoms), of less than or equal to 24 hours duration.
3. Patients able to take the first dose of study medication in the first 24 hours of ILI.

Are the trial subjects under 18? yes
Number of subjects for this age range: 120
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 480
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified