Clinical Trials Register

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

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A. Protocol Information

A.1

Member State Concerned

Czechia - SUKL

A.2

EudraCT number

2019-002747-14

A.3

Full 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.3.1

Title 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.4.1

Sponsor's protocol code number

OF_FUM_CT1

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	"Olainfarm" AS
B.1.3.4	Country	Latvia
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	"Olainfarm" AS
B.4.2	Country	Latvia
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	"Olainfarm" AS
B.5.2	Functional name of contact point	Medical and Regulatory Department
B.5.3	Address:
B.5.3.1	Street Address	5 Rupnicu street
B.5.3.2	Town/ city	Olaine
B.5.3.3	Post code	LV-2114
B.5.3.4	Country	Latvia
B.5.4	Telephone number	+37122016129
B.5.6	E-mail	Gita.Silina@olainfarm.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Furamag
D.2.1.1.2	Name of the Marketing Authorisation holder	"Olainfarm" AS
D.2.1.2	Country which granted the Marketing Authorisation	Latvia
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Furamag 50 mg hard capsules
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Furaginum solubile
D.3.9.1	CAS number	21287-44-5
D.3.9.3	Other descriptive name	FURAGIN SOLUBLE
D.3.9.4	EV Substance Code	SUB35197
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Furantoina®
D.2.1.1.2	Name of the Marketing Authorisation holder	LABORATORIOS ERN, S.A
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Furantoina®
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Nitrofurantoinum
D.3.9.1	CAS number	67-20-9
D.3.9.3	Other descriptive name	NITROFURANTOIN
D.3.9.4	EV Substance Code	SUB09326MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Microbiologically confirmed acute uncomplicated lower urinary tract infections in women.

E.1.1.1

Medical condition in easily understood language

Urinary tract infections

E.1.1.2

Therapeutic 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.1.2	Version	20.0
E.1.2	Level	HLT
E.1.2	Classification code	10046577
E.1.2	Term	Urinary tract infections
E.1.2	System Organ Class	100000004862

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main 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.2.2

Secondary 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.2.3

Trial contains a sub-study

E.3

Principal 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.4

Principal 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.5.1

Primary 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.5.1.1

Timepoint(s) of evaluation of this end point

Visit 3

E.5.2

Secondary 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.5.2.1

Timepoint(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.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Adaptive

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Russian Federation

Latvia

Lithuania

Poland

Czechia

E.8.7

Trial has a data monitoring committee

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.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

745

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

150

F.4.2

For a multinational trial

F.4.2.1

In the EEA

665

F.4.2.2

In 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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2021-05-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-04-21

P. End of Trial
P.	End of Trial Status	Ongoing

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