WHO ICTRP trial

Study to investigate efficacy, safety and tolerability of Furamag in the…

EUCTR2019-002747-14-CZ · EU Clinical Trials Register · Authorised

Key facts

Trial ID EUCTR2019-002747-14-CZ
Public title Study to investigate efficacy, safety and tolerability of Furamag in the treatment of urinary tract infections
Scientific title A multi-center, randomized, double-blind, double-dummy, parallel-group, active drug controlled, adaptive, Phase III study to investigate efficacy, safety and tolerability of Furamag (Furaginum solubile) in the treatment of microbiologically confirmed acute uncomplicated urinary tract infections.
Primary sponsor "Olainfarm" AS
Registry EU Clinical Trials Register
Recruitment status Authorised
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries Czechia;Czech Republic;Poland;Lithuania;Russian Federation;Latvia
Conditions Microbiologically confirmed acute uncomplicated lower urinary tract infections in women. MedDRA version: 20.0 Level: HLT Classification code 10046577 Term: Urinary tract infections System Organ Class: 100000004862 ;Therapeutic area…
Interventions Trade Name: Furamag Product Name: Furamag 50 mg hard capsules Pharmaceutical Form: Capsule, hard INN or Proposed INN: Furaginum solubile CAS Number: 21287-44-5 Other descriptive name: FURAGIN SOLUBLE Concentration unit: mg milligram(s)…
Registration date Dec 4, 2021
Target size 745
Secondary IDs OF_FUM_CT1
Registry page clinicaltrialsregister.eu

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