Study to investigate efficacy, safety and tolerability of Furamag in the treatment of urinary tract infections

Phase 1

• Conditions: Microbiologically confirmed acute uncomplicated lower urinary tract infections in women.; MedDRA version: 20.0Level: HLTClassification code 10046577Term: Urinary tract infectionsSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2019-002747-14-LT
• Lead Sponsor: Olainfarm AS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-06
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 745

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.
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 745
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

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