Phase 4 study evaluate the efficacy of Isoprinosine in patients with infections due to influenza or parainfluenza virus.

• Conditions: Acute Respiratory Viral Infections due to influenza A or B virus, RSV, adenovirus, or parainfluenza virus 1 or 3; MedDRA version: 17.1Level: HLTClassification code 10022005Term: Influenza viral infectionsSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-001863-11-CZ
• Lead Sponsor: Ewopharma AG.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-30
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 430

Inclusion Criteria

1. Male or nonpregnant female subjects aged 18 to 75 years.
Female subjects must be either surgically sterile, postmenopausal (no menses during the previous 12 months), or must be practicing an effective method of birth control as determined by the investigator (eg, oral contraceptives, double barrier methods, injectable or implanted hormonal contraceptives, tubal ligation, or male partner with vasectomy or complete abstinence).
2. Has an influenza-like illness defined as:
• oral temperature of =38°C obtained at study site. If oral temperature measured at screening is <38°C, then the subject will still be eligible if the self-measured temperature at home within 12 hours prior to screening is either an oral temperature of =38°C or an axillary temperature of > 37.5°C and the subject has taken an antipyretic within 4 hours prior to screening
•at least 1 of the following respiratory symptoms: cough, sore throat, or nasal obstruction that is considered by the subject to be moderate or severe in intensity (a score of more than 1 on a 4-point scale [Table S2]) , and
•at least 1 of the following constitutional symptoms: fatigue, headache, myalgia, or feverishness that is considered by the subject to be moderate or severe in intensity (rated greater than mild” on a 4-point scale ).
3.Has onset of influenza-like illness no more than 36 hours prior to screening, defined as when the subject experienced fever and at least 1 respiratory symptom and at least 1 constitutional symptom.
4.Is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements, including completion of the subject diary.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 430
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Has immunosuppressive disorder or who is receiving immunosuppressive therapy (eg, immunosuppressants, antitumour agents).
2.Is receiving treatment with xanthine oxidase inhibitors (allopurinol) or uricosuric agents, or treatment with thiazide diuretics (eg, hydrochlorothiazide, chlorthalidone, and indapamide) or loop diuretics (eg, furosemide, torsemide, and ethacrynic acid).
3.Has chronic renal dysfunction (creatinine clearance <50 mL/min).
4.Has liver disorder (severe liver function impairment; aspartate aminotransferase and alanine aminotransferase values greater than 3 times the upper limit of normal).
5.Is lactose intolerant.
6.Has cancer in a nonremission stage (subject with nonmetastatic basal cell or squamous cell skin cancer or other early cancer for which surgical resection is considered to be completely curative is eligible for enrolment).
7.Is a resident of a nursing home or other long-term care institution.
8.Is receiving treatment with zidovudine.
9.Is pregnant or lactating/breastfeeding female.
10.Has received any dose of Isoprinosine, oseltamivir, zanamivir, amantadine, or rimantadine during this period of influenza-like illness.
11.Has received prior treatment with any investigational drug or vaccine within 30 days prior to screening.
12.Has known hypersensitivity to inosine acedoben dimepranol or any of the excipients comprising Isoprinosine from the 500 mg Isoprinosine tablets.
13.Has a medical history of hyperuricaemia or gout.
14.Is unable to take oral medications.
15.Has any preexisting illness that, in the opinion of the investigator, would place the subject at an increased risk through participation in this study.
16.Is a subject who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.

Study & Design

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