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Efficacy of CLR Compared to Fosfomycin Trometamol in Acute Lower uUTIs

NCT02639520 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 659

Last updated 2017-07-28

No results posted yet for this study

Summary

To demonstrate non-inferiority of a non-antibiotic therapy with CLR versus an antibiotic treatment with fosfomycin trometamol in women suffering from acute lower uUTIs as measured by the proportion of patients who received an additional antibiotic treatment for acute lower uUTIs during the trial.

Conditions

Interventions

DRUG

Canephron® N

2 tablets 3 times a day for 7 days

DRUG

Fosfomycin trometamol

1 sachet of 8 g of granules; one single dose on Day 1

DRUG

Canephron® N-placebo

2 tablets 3 times a day for 7 days

DRUG

Fosfomycin trometamol-placebo

1 sachet of 8 g of granules; one single dose on Day 1

Sponsors & Collaborators

  • Bionorica SE

    lead INDUSTRY

Principal Investigators

  • Florian Wagenlehner, Prof. · Universitätsklinikum Gießen und Marburg GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-06-30
Completion
2017-06-29

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02639520 on ClinicalTrials.gov