randomized and double-blinded dose finding study to evaluate safety and efficacy of carbabenzpyride compared to placebo in uncomplicated influenza A in multiple centers and countries

• Conditions: (Uncomplicated) Influenza A; MedDRA version: 13.1Level: LLTClassification code 10022002Term: Influenza A virus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2010-018564-17-AT
• Lead Sponsor: Farmak International Holding GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-09
• Last Update Posted: 31 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 440

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 constitional 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

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

Study & Design

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