Urinary Tract InfectionPhase 3NCT01478620
Safety and Efficacy of Canephron® N in the Management of Uncomplicated Urinary Tract Infections (uUTI)
A Phase 3 study testing Canephron® N in people with Urinary Tract Infection, run by Bionorica SE at 1 site in Ukraine.
Trial summary
The objective of the study is to assess safety and impact of a non-antibiotic therapy approach with Canephron® N in the management strategy of uncomplicated lower urinary tract infections (UTIs). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- Canephron® N
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUkraine
- Study dates
- Oct 2011to Aug 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Female outpatients aged 18-65 years (both inclusive).
- Patients suffering of symptoms of uncomplicated lower urinary infection at screening. Patients must have a total sum score of at least six for the symptoms dysuria, frequency and urgency.
- Development of symptoms within a maximum of 6 days before screening.
- Willing to refrain from consuming prohibited concomitant medications and products.
- Non-lactating female patients, who are surgically sterile (have had a documented bilateral oophorectomy and/or hysterectomy) or postmenopausal (cessation of menses for more than 1 year), or patients of childbearing potential with a negative pregnancy test at screening willing to use effective contraception methods (intrauterine device [IUD], hormonal contraceptives) during the study.
Main Exclusion Criteria:
- Any signs evoking complicated UTI, pyelonephritis and/or concomitant vulvo-vaginitis
- Any conditions that may lead to complicated infections (that is, renal diseases, urinary tract abnormalities or past urinary surgery, urine catheterization, etc).
- Chronic infection of the urinary tract requiring an intravenous pyelogram (IVP), ultrasound or cystoscopy.
- Current signs or symptoms of severe, progressive or uncontrolled life-threatening systemic disease i.e. renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease.
- Other acute infection (except UTI) requiring antibiotic treatment.
- Patients receiving treatment for presumed or proven urinary tract infection within 4 weeks prior to study entry.
- Antibiotic, immunosuppressive or immunostimulant (incl. vaccines) therapy within 4 weeks prior to study entry.
- Patients with known history of anatomical genitourinary (GU) anomalies or GU surgery within 6 months prior to study entry.
- Patients with known clinically significant abnormalities in screening physical examination, laboratory tests or vital signs.
- Peptic ulcers and hypersensitivity and/or idiosyncrasy to centaury herb, lovage root, rosemary leaves or one of the other ingredients of the investigational medicinal product.
- Rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency, galactose intolerance or lactase deficiency.
- Patients with a history of severe drug allergy or hypersensitivity.
- Known Human Immunodeficiency Virus (HIV)-seropositivity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Non-randomized, Multicenter, Interventional Study to Investigate the Safety and Efficacy of Canephron® N in the Management of Uncomplicated Urinary Tract Infections (uUTI)
The objective of the study is to assess safety and impact of a non-antibiotic therapy approach with Canephron® N in the management strategy of uncomplicated lower urinary tract infections (UTIs).
Read the detailed description
250 patients total 7-day treatment period with Canephron® N (2 tablets three times a day) and a follow-up period until Day 37. A total of three visits are planned on Day 0 (screening, start of study treatment), Day 7 (end of study treatment) and Day 37 (end of study visit).
Additional visits can be performed anytime between Day 1 and Day 37 if deemed necessary by the investigator. In case the patients experience consistent or worsening of symptoms they may be offered antibiotic therapy at the discretion of the investigator at any time. In this case Canephron® N intake will be stopped.
At least 50% of the patients, i.e. 125 subjects, should have received a 7-day treatment with Canephron® N. If less subjects are available recruitment of subjects will be continued until the required number of 125 subjects is reached.
Due to withdrawal of study in Russia total study population was reduced to 125 patients.
- Conditions
- Urinary Tract Infection
- Being tested
- Canephron® N
- 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
3x 2 coated tablets/day for 7 days p.o.
| Study group | Role | What they receive |
|---|---|---|
| Canephron® N | Experimental | Not described Receives: Drug: Canephron® N |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Drug Reactions During 7-day Treatment of uUTI Symptoms With Canephron® N
No study drug related adverse drug reactions were registered.
Measured: During active treatment period (day 1 until day 7)
Secondary outcomes (8)
Incidence of Adverse Drug Reactions During the 7-day Treatment of uUTI Symptoms With Canephron® N in the Subgroup of Patients Who Take Canephron® N for at Least 7 Days
Measured: During active treatment period
Proportion of Patients With no Symptoms Worse Than Mild on Day 7 (i.e. Responders)
Measured: Day 7
Severity of uUTI Symptoms on Day 7
Measured: Day 7
Severity of uUTI Symptoms on Day 37
Measured: Day 37
Duration of uUTI Symptoms
Measured: During active treatment and follow up period (Day 0 - Day 37)
Proportion of Patients Who Require Antibiotic Treatment Until Day 7
Measured: During active treatment period
Proportion of Patients With Early Recurrence [Days] After Clearance of uUTI Symptoms
Measured: During active treatment and follow up period (Day 0 - Day 37)
Time to First Early Recurrence [Days] After Clearance of uUTI Symptoms
Measured: During active treatment and follow up period (Day 0 - Day 37)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bionorica SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dmitry Ivanov, Principal investigator, Kiev regional city hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478620
- Sponsor's protocol ID
- CanUTI2
- Other IDs
- 2011-000838-11
- Status last verified
- Feb 2019
- First submitted
- 21 Nov 2011
- Last updated
- 27 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Non-randomized, Multicenter, Interventional Study to Investigate the Safety and Efficacy of Canephron® N in the Management of Uncomplicated Urinary Tract Infections (uUTI)
- ClinicalTrials.gov ID
- NCT01478620
- Acronym / sponsor ID
- CanUTI2
- Conditions
- Urinary Tract Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Bionorica SEIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 23 Nov 2011 (estimated)
- Results
- Posted 13 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to assess safety and impact of a non-antibiotic therapy approach with Canephron® N in the management strategy of uncomplicated lower urinary tract infections (UTIs).
Detailed description
250 patients total 7-day treatment period with Canephron® N (2 tablets three times a day) and a follow-up period until Day 37. A total of three visits are planned on Day 0 (screening, start of study treatment), Day 7 (end of study treatment) and Day 37 (end of study visit).
Additional visits can be performed anytime between Day 1 and Day 37 if deemed necessary by the investigator. In case the patients experience consistent or worsening of symptoms they may be offered antibiotic therapy at the discretion of the investigator at any time. In this case Canephron® N intake will be stopped.
At least 50% of the patients, i.e. 125 subjects, should have received a 7-day treatment with Canephron® N. If less subjects are available recruitment of subjects will be continued until the required number of 125 subjects is reached.
Due to withdrawal of study in Russia total study population was reduced to 125 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Canephron® N | Experimental | Drug: Canephron® N |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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® N3x 2 coated tablets/day for 7 days p.o. | Drug | Canephron® N |
Primary outcome
Incidence of Adverse Drug Reactions During 7-day Treatment of uUTI Symptoms With Canephron® N
Time frame: During active treatment period (day 1 until day 7)
No study drug related adverse drug reactions were registered.
8 secondary outcomes
Incidence of Adverse Drug Reactions During the 7-day Treatment of uUTI Symptoms With Canephron® N in the Subgroup of Patients Who Take Canephron® N for at Least 7 Days
Time frame: During active treatment period
Proportion of Patients With no Symptoms Worse Than Mild on Day 7 (i.e. Responders)
Time frame: Day 7
Severity of uUTI Symptoms on Day 7
Time frame: Day 7
Severity of uUTI Symptoms on Day 37
Time frame: Day 37
Duration of uUTI Symptoms
Time frame: During active treatment and follow up period (Day 0 - Day 37)
Proportion of Patients Who Require Antibiotic Treatment Until Day 7
Time frame: During active treatment period
Proportion of Patients With Early Recurrence [Days] After Clearance of uUTI Symptoms
Time frame: During active treatment and follow up period (Day 0 - Day 37)
Time to First Early Recurrence [Days] After Clearance of uUTI Symptoms
Time frame: During active treatment and follow up period (Day 0 - Day 37)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Dmitry Ivanov principal investigator
Kiev regional city hospital
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 in people with Urinary Tract Infection, run by Bionorica SE at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 27 Feb 2019. 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 Ukraine. 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?
Yes. Results are posted in the registry (first posted 13 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Adverse Drug Reactions During 7-day Treatment of uUTI Symptoms With Canephron® N (time frame: During active treatment period (day 1 until day 7)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2019.