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    The EU Clinical Trials Register currently displays   41501   clinical trials with a EudraCT protocol, of which   6826   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2019-002747-14
    Sponsor's Protocol Code Number:OF_FUM_CT1
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-04-12
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2019-002747-14
    A.3Full title of the trial
    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.
    Multicentrické, randomizované, dvojitě zaslepené, dvojitě matoucí, paralelně uspořádané, aktivní látkou kontrolované klinické hodnocení s adaptivním designem fáze III pro vyhodnocení účinnosti, bezpečnosti a snášenlivosti Furamagu (Furaginum solubile) při léčbě mikrobiologicky potvrzených nekomplikovaných akutních infekcí močového traktu.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to investigate efficacy, safety and tolerability of Furamag in the treatment of urinary tract infections
    A.4.1Sponsor's protocol code numberOF_FUM_CT1
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of Sponsor"Olainfarm" AS
    B.1.3.4CountryLatvia
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support"Olainfarm" AS
    B.4.2CountryLatvia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation"Olainfarm" AS
    B.5.2Functional name of contact pointMedical and Regulatory Department
    B.5.3 Address:
    B.5.3.1Street Address5 Rupnicu street
    B.5.3.2Town/ cityOlaine
    B.5.3.3Post codeLV-2114
    B.5.3.4CountryLatvia
    B.5.4Telephone number+37122016129
    B.5.6E-mailGita.Silina@olainfarm.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Furamag
    D.2.1.1.2Name of the Marketing Authorisation holder"Olainfarm" AS
    D.2.1.2Country which granted the Marketing AuthorisationLatvia
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFuramag 50 mg hard capsules
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFuraginum solubile
    D.3.9.1CAS number 21287-44-5
    D.3.9.3Other descriptive nameFURAGIN SOLUBLE
    D.3.9.4EV Substance CodeSUB35197
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Furantoina®
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATORIOS ERN, S.A
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFurantoina®
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNitrofurantoinum
    D.3.9.1CAS number 67-20-9
    D.3.9.3Other descriptive nameNITROFURANTOIN
    D.3.9.4EV Substance CodeSUB09326MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Microbiologically confirmed acute uncomplicated lower urinary tract infections in women.
    E.1.1.1Medical condition in easily understood language
    Urinary tract infections
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10046577
    E.1.2Term Urinary tract infections
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the clinical and bacteriological efficacy of Furamag 50 mg hard capsules (containing 50 mg of Furaginum solubile) in the treatment of microbiologically confirmed acute uncomplicated urinary tract infections in women taken 2 hard capsules three times a day (300 mg/day) for 5 days in comparison to the active comparator, Furantoina® 50 mg tablets (containing 50 mg of Nitrofurantoinum), taken 2 tablets three times a day (300 mg/day) for 5 days
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of Furamag 50 mg hard capsules (containing 50 mg of Furaginum solubile) in the treatment of microbiologically confirmed acute uncomplicated urinary tract infections in women taken 2 hard capsules three times a day (300 mg/day) for 5 days in comparison to the active comparator, Furantoina® 50 mg tablets (containing 50 mg of Nitrofurantoinum), taken 2 tablets three times a day (300 mg/day) for 5 days
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female outpatients aged between 18 and 55 years (inclusive).
    2. Patients with all below defined clinical signs and symptoms of uUTI:
    • Dysuria (discomfort associated with urination).
    •Urinary frequency (abnormally frequent urination).
    •Urinary urgency (abrupt, strong, often overwhelming, need to urinate).
    3. Patients with onset of symptoms of uUTI ≤ 72 hours prior to randomization.
    4. Urine dipstick test positive for either nitrites and/or leukocyte esterase.
    5. Patients who signed written informed consent.
    6. Patients in a good general physical and mental health as determined by Investigator.
    E.4Principal exclusion criteria
    1. Patients who are pregnant or breast-feeding, or with positive pregnancy test at screening.
    2. Patients of child-bearing potential who are not using acceptable effective contraceptive method(s).
    3. Patients with vaginal discharge or irritation.
    4. Patients with known or suspected hypersensitivity or intolerance to Nitrofurantoinum, Furaginum solubile, other nitrofuran derivatives, or to any excipients of investigational medicinal products.
    5. Patients unable to take oral medication for any reason.
    6. Patients with complicated urinary tract infection or pyelonephritis suggested by the presence of systemic and/or local signs and symptoms: fever (body temperature > 38 °C), chills, flank pain, nausea, vomiting, or costovertebral angle tenderness.
    7. Patients with known (in medical history) presence of an anatomical or functional abnormality of the urinary tract including urinary calculi, stricture, primary renal disease (e.g., polycystic renal disease), neurogenic bladder.
    8. Patients with the presence of urinary catheterization, currently or within the 4 weeks prior to randomization.
    9. Patients with symptoms of a lower urinary tract infection (UTI) – dysuria, urinary urgency, urinary frequency – within the 4 weeks prior to the present episode.
    10. Patients with three or more episodes of any UTI in the past 12 months.
    11. Patients with evidence of uncontrolled diabetes mellitus.
    12. Patients who received systemic antimicrobial therapy within 72 hours prior to randomization.
    13. Patients who received products containing cranberry (Vaccinium macrocarpon) within 24 hours prior to randomization.
    14. Patients who received Magnesium trisilicate (antacid) within 2 hours prior to randomization.
    15. Patients with known immunosuppression and/or neutropenia with a neutrophil count <1000/mm3 in the past 24 months.
    16. Patients with renal impairment (estimated baseline glomerular filtration rate (eGFR) < 45 mL/min/1.73 m²).
    17. Patients with clinically significant pulmonary disease.
    18. Patients with known anaemia, deficiency of vitamin B group or folic acid.
    19. Patients with clinically significant hepatic disease.
    20. Patients with polyneuropathy (including diabetic).
    21. Patients with porphyria.
    22. Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency.
    23. Patients requiring concomitant systemic antibacterial therapy with agents not specified in this protocol.
    24. Patients requiring therapy with non-steroidal anti-inflammatory drugs (NSAIDs) on a regular basis.
    25. Patients with any condition which, in the opinion of the Investigator, affects the safety of the patient, and/or the patient’s ability to participate in this study.
    26. Patients previously enrolled in this clinical study and/or at the time of screening participate in other clinical study in parallel.
    27. Patients taking an investigational medicinal product currently or in the last 30 days.
    28. Patients who, in the opinion of the Investigator, are unsuitable for enrollment, unlikely to complete the course of study medication treatment, or unlikely to attend the end of study visit.
    E.5 End points
    E.5.1Primary end point(s)
    Combined clinical and bacteriological response: Resolution of the symptoms of uUTI (clinical response) and demonstration that the true uropathogen found at randomization is reduced to less than 103 CFU/mL (bacteriological response) assessed at Visit 3 (Day 12 + 2 days) using the micro-ITT population.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 3
    E.5.2Secondary end point(s)
    • For efficacy (primary population is the micro-ITT population):
    - Combined clinical and bacteriological response is evaluated at Visit 2 (Day 6 + 2 days) and at Visit 4 (Day 28 ± 2 days).
    - Clinical response (assessed by UTISA) at further ancillary time points during treatment period (Days 2–5), at Visit 2 (Day 6 + 2 days), Visit 3 (Day 12+2 days) and at Visit 4 (Day 28 ± 2 days)
    - Bacteriological response is evaluated at Visit 2 (Day 6 + 2 days), at Visit 3 (Day 12 + 2 days) and at Visit 4 (Day 28 ± 2 days).
    • For safety (assessed using safety population): AEs, SAEs, CSIs, Safety laboratory values (blood tests and urinalysis), vital signs, and physical examination findings.
    • For tolerability (assessed using safety population): Number of drug-related AEs/SAEs/CSIs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Treatment period Day 2 - 5, Visit 2 and Visit 4
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Adaptive
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Czechia
    Latvia
    Lithuania
    Poland
    Russian Federation
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months18
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 745
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 665
    F.4.2.2In the whole clinical trial 745
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    According to standard of care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-21
    P. End of Trial
    P.End of Trial StatusOngoing
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