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Clinical Trials/EUCTR2013-004653-25-DE
EUCTR2013-004653-25-DE
Active, not recruiting
Phase 1

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

Repha GmbH0 sites224 target enrollmentFebruary 25, 2014
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ConditionsContinuous prophylaxis of chronically recurring uncomplicated cystitisMedDRA version: 20.1 Level: LLT Classification code 10011786 Term: Cystitis chronic System Organ Class: 100000004862MedDRA version: 21.1 Level: PT Classification code 10063057 Term: Cystitis noninfective System Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
DrugsAngocin Anti-Infekt N

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Continuous prophylaxis of chronically recurring uncomplicated cystitis
Sponsor
Repha GmbH
Enrollment
224
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 25, 2014
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Repha GmbH

Eligibility 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 (\<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:

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

Outcomes

Primary Outcomes

Not specified

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