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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004653-25-DE

Enrollment

224

Registered

2014-02-25

Start date

2014-05-02

Completion date

Unknown

Last updated

2020-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: Angocin Anti-Infekt N Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Horseradish root powder Other descriptive name: Meerretti

Eligibility

Sex/Gender

All

Inclusion criteria

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 (=65 years) yes F.1.3.1 Number of subjects for this age range 24

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Rates of first recurrences, observed during the six-month medicinal prophylaxis within the test group and the placebo group; Secondary Objective: - Time without recurrences during prophylaxis - Rates of recurrences at the scheduled visits during prophylaxis - Rates of recurrences during the three- rep. six-month follow-up - Investigator's assessment of efficacy at the end of prophylaxis - Investigator's assessment of continual efficacy following the end of prophylaxis - Type, frequency and severity of reported adverse Events - Development of laboratory results for blood samples during prophylaxis: Haematology and clinical chemistry - Development of vital signs during prophylaxis: Pulse, blood pressure, body temperature - Tolerance of study medication - Compliance - Patient satisfaction - Results of pathogen identification after recurrence - Results of resistance testing against ANGOCIN® Anti-Infekt N after recurrence during prophylaxis ;Primary end point(s): Symptomatic infections with = 10³ CFU of uropahtogens/ml urine, confirmed by a central laboratory during the six-month prophylaxis; only the first recurrence after Initiation of prophylaxis is recorded;Timepoint(s) of evaluation of this end point: After conclusion of the prophylaxis (at the latest after six-month intake of the study medication) and during the scheduled visits	—

Measure

Time frame

Main Objective: Rates of first recurrences, observed during the six-month medicinal prophylaxis within the test group and the placebo group; Secondary Objective: - Time without recurrences during prophylaxis - Rates of recurrences at the scheduled visits during prophylaxis - Rates of recurrences during the three- rep. six-month follow-up - Investigator's assessment of efficacy at the end of prophylaxis - Investigator's assessment of continual efficacy following the end of prophylaxis - Type, frequency and severity of reported adverse Events - Development of laboratory results for blood samples during prophylaxis: Haematology and clinical chemistry - Development of vital signs during prophylaxis: Pulse, blood pressure, body temperature - Tolerance of study medication - Compliance - Patient satisfaction - Results of pathogen identification after recurrence - Results of resistance testing against ANGOCIN® Anti-Infekt N after recurrence during prophylaxis ;Primary end point(s): Symptomatic infections with = 10³ CFU of uropahtogens/ml urine, confirmed by a central laboratory during the six-month prophylaxis; only the first recurrence after Initiation of prophylaxis is recorded;Timepoint(s) of evaluation of this end point: After conclusion of the prophylaxis (at the latest after six-month intake of the study medication) and during the scheduled visits

—

Secondary

Measure	Time frame
Secondary end point(s): Symptomatic infections with = 10³ CFU of uropahtogens/ml urine, confirmed by a central laboratory during the six-month follow-up; only the first recurrence after Initiation of prophylaxis is recorded;Timepoint(s) of evaluation of this end point: For patients without recurrence during prophylaxis: After conclusion of the follow-up (at the latest six months after conclusion of the prophylaxis)	—

Measure

Time frame

Secondary end point(s): Symptomatic infections with = 10³ CFU of uropahtogens/ml urine, confirmed by a central laboratory during the six-month follow-up; only the first recurrence after Initiation of prophylaxis is recorded;Timepoint(s) of evaluation of this end point: For patients without recurrence during prophylaxis: After conclusion of the follow-up (at the latest six months after conclusion of the prophylaxis)

—

Countries

Germany

Contacts

Public ContactClinical Research

Mediconomics GmbH

info@mediconomics.com004905115609980

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 7, 2026