Safety and Efficacy of Canephron® N in the Management of Uncomplicated Urinary Tract Infections (uUTI)
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ClinicalTrials.gov Identifier: NCT01478620 |
Recruitment Status :
Completed
First Posted : November 23, 2011
Results First Posted : October 13, 2014
Last Update Posted : February 27, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Urinary Tract Infection | Drug: Canephron® N | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 125 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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) |
Study Start Date : | October 2011 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | August 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Canephron® N |
Drug: Canephron® N
3x 2 coated tablets/day for 7 days p.o. |
- 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.
- 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) ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01478620
Ukraine | |
Kiev Regional City Hospital | |
Kiev, Ukraine, 04107 |
Principal Investigator: | Dmitry Ivanov | Kiev regional city hospital |
Responsible Party: | Bionorica SE |
ClinicalTrials.gov Identifier: | NCT01478620 |
Other Study ID Numbers: |
CanUTI2 2011-000838-11 ( EudraCT Number ) |
First Posted: | November 23, 2011 Key Record Dates |
Results First Posted: | October 13, 2014 |
Last Update Posted: | February 27, 2019 |
Last Verified: | February 2019 |
Infections Communicable Diseases Urinary Tract Infections |
Disease Attributes Pathologic Processes Urologic Diseases |