(Uncomplicated) Influenza A MedDRA version: 13.1 Level: LLT Classification code 10022002 Term: Influenza A virus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Carbabenzypride 125 mg capsules
Product Code: FAV00A (125 mg)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Carbabenzpyride
CAS Number: 201 349-37-3
Current Sponsor code: FAV00
Sponsors
Farmak International Holding GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject who has given his / her signed declaration of consent and data protection declaration after having been informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the subjects participating in the study. 2. Male or female outpatient subject at the age between 18 and 65 years 3. Diagnosis of influenza A· - characterized by the presence of at least one respiratory symptom (cough, sore throat or nasal symptoms) of at least moderate severity - characterized by the presence of at least one constitutional symptom (headache, myalgia sweats and / or chills, or fatigue) of at least moderate severity· characterized by fever = 37.5°C / = 99.5°F (sublingual) measured at the investigator’s office· - onset of symptoms no longer than 36 hours prior to randomization; onset of symptoms is defined as appearance of at least one respiratory and one constitutional symptom of any severity - positive influenza A rapid antigen test performed with a commercially available test kit on an adequate nasopharyngeal swab Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 400
Exclusion criteria
Exclusion criteria: Medical conditions 1. Influenza with concurrent clinical evidence of otitis media, bronchitis, rhinosinusitis and / or pneumonia or any other bacterial infection requiring therapy with oral or systemic antibiotics 2. Influenza - except the current infection - within the past 3 months prior to study enrollment 3. Presence or history of hypothyroidism, hyperthyroidism or thyroiditis (e.g., Hashimoto’s or Basedow’s disease, subacute thyroiditis) or history of hemithyroidectomy; presence of goiter 4. Subject with BMI > 35 kg/m2 5. Presence of relevant pulmonary disease (e.g., asthma, treatment requiring chronic obstructive pulmonary disease (COPD), cystic fibrosis, alpha-1-antitrypsin deficiency, sarcoidosis, bronchiectasis, allergic alveolitis, tuberculosis) 6. Existing cardiac, hematological, hepatic, renal, gastrointestinal and / or pathological findings, which might interfere with the drug’s safety, tolerability and / or absorption 7. Major surgery of the gastrointestinal tract, mal-absorption and / or mal-digestion 8. History or presence of malignant growth 9. Subject with impaired hematopoesis or coagulation disorder including medically induced inhibition of coagulation 10. Subject with active peptic ulcer or history of recurrent ulceration 11. Subject with gastrointestinal, cerebrovascular or other active bleeding 12. History or presence of relevant CNS and psychiatric disorders and currently treated CNS and psychiatric disorders 13. Presence of immuno-compromised status due to chronic illness, previous organ transplant or use of immunomodulatory or -suppressive therapy including oral or systemic corticosteroids within the past 4 weeks prior to study enrollment 14. Subject with known positive HIV test result 15. History or presence of drug allergy or hypersensitivity (e.g., anaphylaxis, urticaria, angiooedema, exanthema, erythema multiforme majus) 16. Subject with current signs of an allergy (e.g., skin or respiratory tract manifestations) 17. History or presence of hypersensitivity to iodine containing drugs and / or to the active ingredient or any excipient of the study medication 18. History or presence of drug or alcohol abuse (alcohol consumption > 40 g and > 20 g / day for male and female subjects, respectively) 19. Abnormal 12-lead ECG which might interfere with drug safety (e.g., but not limited to PR > 250 ms or higher degree av-block, QTc-prolongation, rhythm disorders, ectopic rhythm, complete right or left bundle branch block, hemi- and bifascicular blocks) 20. Positive TSH rapid test performed with a commercially available test kit / TSH value outside normal range in local laboratory in countries without licensed TSH rapid test 21. TSH value at Visit 1 outside normal range according to central laboratory 22. Laboratory value(s) out of normal range, unless the deviation from normal is judged as clinically not relevant by the investigator (e.g., but not limited to ASAT and / or ALAT > 2xULN, creatinine > 2.0 mg/dL) 23. Systemic use of iodine containing medications (e.g., amiodarone) or large-area use of iodine-containing antiseptics for local treatment of wounds or use of lithium within the last 6 months prior to study enrollment 24. Influenza vaccination or application of a live vaccine within the past 4 weeks prior to study enrollment 25. Treatment with antiviral drugs (e.g., neuraminidase inhibitors) within the past 2 weeks prior to study enrollment 26. Treatment with anticoagulants or with CYP2D6-substrates / -inhibi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of an 8-day treatment with carbabenzpyride in adult subjects with influenza A in three different dosages compared to placebo on the basis of the duration of illness in terms of alleviation of symptoms.;Secondary Objective: To assess the safety of three different doses of carbabenzpyride compared to placebo in subjects with influenza A. To determine the dose with the best benefit / risk ratio for the treatment of influenza A.;Primary end point(s): The primary endpoint is defined as: Time to alleviation [days] of influenza symptoms from Day 1 (Visit 1) to Day 22 comparing different dosages of carbabenzpyride with placebo in the Full Analysis Set (FAS) population. The time to alleviation [days] of symptoms (cough, sore throat, nasal symptoms, headache, fatigue, myalgia, sweat and / or chill) will be calculated for a (maximum) observation period of 21 days (Day 1 to Day 22). Alleviation is defined as the start of a 24 ± 3 hour period, in which a symptom is less or equal to mild intensity (i.e. score = 1) and does not increase during that period. The analysis of the primary endpoint will be based on the subjects’ daily diary assessments. ;Timepoint(s) of evaluation of this end point: Continuously up to Day 22. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The AUC of all symptoms (sum of scores of all influenza symptoms) will be calculated from Day 1 to Day 22 as assessed by the subject in the diary and analyzed by the ANOVA with the factors “treatment” and “geographical regions“, and baseline as covariate using Dunnett’s test approach and tested for each active treatment group vs. placebo. In addition with the nonparametric Wilcoxon-Mann-Whitney test adjusted for “geographical regions” (van Elteren’s test) will be calculated. In order to show a dose-response relationship, also the Jonkheere-Terpstra test will be performed. 2. The duration of each individual symptom of influenza from Day 1 to Day 22 as assessed by the subject in the diary will be analyzed analogously to the primary endpoint. 3. The AUC of each individual symptom of influenza from Day 1 to Day 22 as assessed by the subject in the diary will be analyzed by the Wilcoxon test adjusted for “geographical regions” (van Elteren’s test) for each treatment group vs. placebo. 4. The AUC of all symptoms (sum of scores of all influenza symptoms) calculated from Day 1 to Day 22 for two subgroups, either with or without intake of paracetamol / acetaminophen during the course of the study will be analyzed by the ANCOVA with the factors “treatment” and “geographical regions“, and baseline as covariate using Dunnett’s test approach will be tested pairwise for each active treatment group vs. placebo. In addition, the nonparametric Wilcoxon test adjusted for “geographical regions” (Van Elteren’s test) will be calculated. 5. The AUC of virus titer per dose group from Visit 1 to Visit 5 will be log-transferred and analyzed by the ANCOVA with the factors “treatment” and “geographical regions“, and baseline as covariate using Dunnett’s test approach for each active treatment group vs. placebo. 6. The AUC of antibody response (HAI) from Visit 1 to Visit 6 will be log-transferred and tested by the ANCOVA with the factors “treatment” and “geographical | — |
Countries
Argentina, Australia, Austria, Canada, Germany, New Zealand, South Africa
Outcome results
None listed