Urinary Tract InfectionPhase 3NCT02639520
Efficacy of CLR Compared to Fosfomycin Trometamol in Acute Lower uUTIs
A Phase 3 study testing Canephron® N and Fosfomycin trometamol in people with Urinary Tract Infection, run by Bionorica SE at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- Canephron® N and Fosfomycin trometamol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 659 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2015to 29 Jun 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent (IC) and data protection declaration
- Female outpatients aged 18 to 70 years
- Sum-score of the main uUTI symptoms (dysuria, pollakisuria, and urgency) reported on the Acute Cystitis Symptom Score (ACSS)-"Typical" domain at Visit 1 is ≥6
- Symptoms of the acute episode of lower uUTI are developed within not more than 6 days prior to Visit 1
- Leukocyturia at Visit 1, confirmed by positive dipstick
- Patients willing to refrain from consuming prohibited concomitant medications and products
- Non-lactating female patients who are surgically sterile (have had a documented sterilization, bilateral oophorectomy at least 3 months before the start of the trial and/or hysterectomy), or postmenopausal (cessation of menses for at least 12 months), or women of childbearing potential with a negative pregnancy test at Visit 1 willing to use highly effective (failure rate less than 1% per year, i.e., Pearl Index <1) contraception methods, e.g., contraceptive patch, oral, injected or implanted hormonal methods of contraception, during the trial including the follow-up period.
Who cannot join
- Any signs of complicated urinary tract infections (UTIs), pyelonephritis (i.e., fever T ≥38.0°C [grade 2], flank and/or back pain, chills and shivers), and/or vulvo-vaginitis with vaginal and/or with urethral discharge (without urination) at Visit 1.
- Any conditions that may lead to complicated infections (i.e., renal diseases, urinary tract abnormalities or past urinary surgery, urine catheterization, uncontrolled diabetes mellitus, spinal cord injury, etc.).
- Chronic infection of the urinary tract known from medical history.
- Persisting signs or symptoms of severe, progressive, or uncontrolled systemic disease (i.e., renal, hepatic, biliary, hematological, gastro-intestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease).
- Uncontrolled hypertension (a diastolic blood pressure >95 mmHg at Visit 1).
- Known severe cardiac insufficiency, coronary heart disease, valvular heart disease, cardiac arrhythmia, QT interval prolongation or other severe cardiac disease at Visit 1.
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- Any antibiotic therapy within 30 days prior to Visit 1.
- Other acute infections (except uUTIs) requiring antibiotic treatment at Visit 1.
- Patients receiving treatment for suspected or confirmed UTI (antibiotic or phytopharmaceutical) within 30 days prior to Visit 1.
- Patients who took anti-inflammatory drugs (e.g., ibuprofen) or spasmolytics for any reason within 24 hours prior to Visit 1, and/or are not willing to stop the intake of any of the medication not permitted for use during the trial.
- Known severe impaired renal function (creatinine clearance <20 mL/min).
- Active peptic ulcers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Controlled, Parallel-group, Randomized, Multicenter Clinical Trial to Assess the Efficacy and Safety of a Herbal Drug Containing Centaury, Lovage Root and Rosemary Leaf (CLR) in Comparison to Fosfomycin Trometamol for the Treatment of Acute Lower Uncomplicated Urinary Tract Infections (uUTIs) in Women
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.
Read the detailed description
The trial is designed as a comparison of two different modes of action in order to look for alternatives to antibiotic treatment of uncomplicated UTIs. Treatment with CLR is a nonantibiotic therapy and is compared to an antibiotic treatment. Thus, the trial aim is to reduce antibiotics use and moreover to reduce the pressure of developing bacterial resistance against antibiotics due to widespread use, which is an additional advantage of the CLR therapy.
The trial results are expected to demonstrate that antibiotic prescriptions in women for treatment of lower uUTIs can be reduced by an alternative and safe non-antibiotic treatment.
- Conditions
- Urinary Tract Infection
- Being tested
- Canephron® N, Fosfomycin trometamol, Canephron® N-placebo, Fosfomycin trometamol-placebo
- Keywords
- Uncomplicated urinary tract infection
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canephron® NDrug
2 tablets 3 times a day for 7 days
Fosfomycin trometamolDrug
1 sachet of 8 g of granules; one single dose on Day 1
Canephron® N-placeboDrug
2 tablets 3 times a day for 7 days
Fosfomycin trometamol-placeboDrug
1 sachet of 8 g of granules; one single dose on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Group Canephron® N | Active comparator | Canephron® N \& fosfomycin trometamol-placebo Receives: Drug: Canephron® N; Drug: Fosfomycin trometamol-placebo |
| Group Fosfomycin Trometamol | Active comparator | Canephron® N-placebo \& fosfomycin trometamol Receives: Drug: Fosfomycin trometamol; Drug: Canephron® N-placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intake of any additional antibiotic medication for acute lower uUTIs between Visit 1 and Visit 4
For patients with consistent or worsening of acute lower uUTI symptoms during the trial the investigator may offer an additional antibiotic therapy at any post-baseline visit. In this case, the patient will be considered a "treatment failure" due to lack of efficacy of the IMP. The alternative antibiotic therapy offered to the patient and the reason for the alternative therapy (i.e., persisting or recurrent symptoms) is to be documented.
The primary variable for the assessment of efficacy is the proportion of patients who received additional antibiotic treatment for acute lower uUTI between Visit 1 and Visit 4 (defined as AB-rate).
Measured: within 38 days after Visit 1 (=day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJun 2017
- Study completion29 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 659 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bionorica SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Florian Wagenlehner, Prof., Principal investigator, Universitätsklinikum Gießen und Marburg GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639520
- Sponsor's protocol ID
- CanUTI-7
- Status last verified
- Jul 2017
- First submitted
- 11 Dec 2015
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Wagenlehner FM, Abramov-Sommariva D, Holler M, Steindl H, Naber KG. Non-Antibiotic Herbal Therapy (BNO 1045) versus Antibiotic Therapy (Fosfomycin Trometamol) for the Treatment of Acute Lower Uncomplicated Urinary Tract Infections in Women: A Double-Blind, Parallel-Group, Randomized, Multicentre, Non-Inferiority Phase III Trial. Urol Int. 2018;101(3):327-336. doi: 10.1159/000493368. Epub 2018 Sep 19.
PubMed 30231252
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Controlled, Parallel-group, Randomized, Multicenter Clinical Trial to Assess the Efficacy and Safety of a Herbal Drug Containing Centaury, Lovage Root and Rosemary Leaf (CLR) in Comparison to Fosfomycin Trometamol for the Treatment of Acute Lower Uncomplicated Urinary Tract Infections (uUTIs) in Women
- ClinicalTrials.gov ID
- NCT02639520
- Acronym / sponsor ID
- CanUTI-7
- Conditions
- Urinary Tract Infection
- Keywords
- Uncomplicated urinary tract infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 659 participants (actual)
- Lead sponsor
- Bionorica SEIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- 29 Jun 2017 (actual)
- First posted
- 24 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The trial is designed as a comparison of two different modes of action in order to look for alternatives to antibiotic treatment of uncomplicated UTIs. Treatment with CLR is a nonantibiotic therapy and is compared to an antibiotic treatment. Thus, the trial aim is to reduce antibiotics use and moreover to reduce the pressure of developing bacterial resistance against antibiotics due to widespread use, which is an additional advantage of the CLR therapy.
The trial results are expected to demonstrate that antibiotic prescriptions in women for treatment of lower uUTIs can be reduced by an alternative and safe non-antibiotic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Canephron® N | Active comparator | Drug: Canephron® N, Drug: Fosfomycin trometamol-placeboCanephron® N \& fosfomycin trometamol-placebo |
| Group Fosfomycin Trometamol | Active comparator | Drug: Fosfomycin trometamol, Drug: Canephron® N-placeboCanephron® N-placebo \& fosfomycin trometamol |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent (IC) and data protection declaration
- Female outpatients aged 18 to 70 years
- Sum-score of the main uUTI symptoms (dysuria, pollakisuria, and urgency) reported on the Acute Cystitis Symptom Score (ACSS)-"Typical" domain at Visit 1 is ≥6
- Symptoms of the acute episode of lower uUTI are developed within not more than 6 days prior to Visit 1
- Leukocyturia at Visit 1, confirmed by positive dipstick
Key exclusion criteria (12 listed)
- Any signs of complicated urinary tract infections (UTIs), pyelonephritis (i.e., fever T ≥38.0°C [grade 2], flank and/or back pain, chills and shivers), and/or vulvo-vaginitis with vaginal and/or with urethral discharge (without urination) at Visit 1.
- Any conditions that may lead to complicated infections (i.e., renal diseases, urinary tract abnormalities or past urinary surgery, urine catheterization, uncontrolled diabetes mellitus, spinal cord injury, etc.).
- Chronic infection of the urinary tract known from medical history.
- Persisting signs or symptoms of severe, progressive, or uncontrolled systemic disease (i.e., renal, hepatic, biliary, hematological, gastro-intestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease).
- Uncontrolled hypertension (a diastolic blood pressure >95 mmHg at Visit 1).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Canephron® N2 tablets 3 times a day for 7 days | Drug | Group Canephron® N |
| Fosfomycin trometamol1 sachet of 8 g of granules; one single dose on Day 1 | Drug | Group Fosfomycin Trometamol |
| Canephron® N-placebo2 tablets 3 times a day for 7 days | Drug | Group Fosfomycin Trometamol |
| Fosfomycin trometamol-placebo1 sachet of 8 g of granules; one single dose on Day 1 | Drug | Group Canephron® N |
Primary outcome
Intake of any additional antibiotic medication for acute lower uUTIs between Visit 1 and Visit 4
Time frame: within 38 days after Visit 1 (=day 1)
For patients with consistent or worsening of acute lower uUTI symptoms during the trial the investigator may offer an additional antibiotic therapy at any post-baseline visit. In this case, the patient will be considered a "treatment failure" due to lack of efficacy of the IMP. The alternative antibiotic therapy offered to the patient and the reason for the alternative therapy (i.e., persisting or recurrent symptoms) is to be documented. The primary variable for the assessment of efficacy is the proportion of patients who received additional antibiotic treatment for acute lower uUTI between Visit 1 and Visit 4 (defined as AB-rate).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
- Derived from this study: PubMed 30231252Wagenlehner FM, Abramov-Sommariva D, Holler M, Steindl H, Naber KG. Non-Antibiotic Herbal Therapy (BNO 1045) versus Antibiotic Therapy (Fosfomycin Trometamol) for the Treatment of Acute Lower Uncomplicated Urinary Tract Infections in Women: A Double-Blind, Parallel-Group, Randomized, Multicentre, Non-Inferiority Phase III Trial. Urol Int. 2018;101(3):327-336. doi: 10.1159/000493368. Epub 2018 Sep 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florian Wagenlehner, Prof. principal investigator
Universitätsklinikum Gießen und Marburg GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Canephron® N and Fosfomycin trometamol in people with Urinary Tract Infection, run by Bionorica SE at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intake of any additional antibiotic medication for acute lower uUTIs between Visit 1 and Visit 4 (time frame: within 38 days after Visit 1 (=day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02639520, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017.