Clinical trial for examination of efficacy and safety of ANGOCIN® Anti-Infekt N versus placebo in the continous prophylaxis of chronically recurring uncomplicated cystitis

Phase 1

• Conditions: Continuous prophylaxis of chronically recurring uncomplicated cystitis; MedDRA version: 20.1 Level: LLT Classification code 10011786 Term: Cystitis chronic System Organ Class: 100000004862; MedDRA version: 21.1 Level: PT Classification code 10063057 Term: Cystitis noninfective System Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-004653-25-DE
• Lead Sponsor: Repha GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-25
• Last Update Posted: 11 March 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 224

Inclusion Criteria

- Outpatients suffering from acute uncomplicated cystitis during screening (visit 1), confirmed by positive urine culture (=10³ CFU/ml Urine)
- History of chronically recurring uncomplicated cystitis (including the current cystitis at least three within the last twelve months or at previous two within the previous two months)
- Negative urine culture for visit 2 (<10³ CFU/ml urine)
- No characteristic symptoms of an acute uncomplicated cystitis during randomisation (visit 3)
- Patients of both sexes aged = 18 years
- Patients having signed written informed consent
- The Patient is willing and able to complete his participation in the clinical trial and to comply with the instructions

CFU = Colony-forming units
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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

- Presence of factors which could indicate a complicated urinary tract infection: body temperature above 38,0°C (fever), flank pain or painful renal bed
- Progression of infection proximal of urinary bladder or spreading of pathogens (pyelonephritis, urosepsis)
- Irritable bladder syndrome
- Known abnormalities or obstruction of the urinary tract
- History of surgery of the urinary tract
- Signs of restricted renal function
- Acute infections besides infections of the lower urinary tract
- Pretreatment of the acute urinary tract infection with antibiotics, herbal medicinal products or homeopathics
- Glomerulonephritis / interstitial nephritis or proteinuria
- Acute gastric ulcer or acute ulcer of duodenum
- Abnormal laboratory results clinically significant)
- Patients with permanent catheter
- Patients with risk factors for a more severe progression
- Intake of oral anticoagulants (Vitamin-K-antagonists; e.g. Phenprocoumon, Warfarin)
- Patients with organ transplantation within the previous 3 years
- Patients with malignant diseases within the previous 5 years
- Patients with HIV
- Pregnant or breast-feeding women or women planning to become pregnant; women capable of bearing children and not applying a highly effective contraception (Pearl Index <1)
- Patients with a medical condition or a situation which, in the opinion of the investigator, poses a significant risk to the patient or which could impair or considerably influence the results of the trial
- Known hypersensitivity to nasturtium, horseradish root or any excipient of the study medication
- Patients receiving a medicinal prophylaxis besides the study medication; the concomitant intake of herbal products with potential prophylactic efficacy, as for instance cranberry, dog rose or kidney and bladder tea, is also not allowed
- Simultaneous participation in another trial or participation in a clinical trial within the last 30 days before inclusion into this Trial
- Known abuse of medicinal products, alcohol or other drugs
- Serious diseases of the Psyche
- Persons which are institutionalised by regulatory or judicial decree

Study & Design

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