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Safety and Efficacy of Canephron® N in the Management of Uncomplicated Urinary Tract Infections (uUTI)

Primary Purpose

Urinary Tract Infection

Status

Completed

Phase

Phase 3

Locations

Ukraine

Study Type

Interventional

Intervention

Canephron® N

About this trial

This is an interventional treatment trial for Urinary Tract Infection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Kiev Regional City Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Canephron® N

Arm Description

Outcomes

Primary Outcome Measures

Incidence of Adverse Drug Reactions During 7-day Treatment of uUTI Symptoms With Canephron® N

No study drug related adverse drug reactions were registered.

Secondary Outcome Measures

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

Proportion of Patients With no Symptoms Worse Than Mild on Day 7 (i.e. Responders)

Severity of uUTI Symptoms on Day 7

Severity of uUTI Symptoms on Day 37

Duration of uUTI Symptoms

Proportion of Patients Who Require Antibiotic Treatment Until Day 7

Proportion of Patients With Early Recurrence [Days] After Clearance of uUTI Symptoms

Time to First Early Recurrence [Days] After Clearance of uUTI Symptoms

Full Information

NCT ID

NCT01478620

First Posted

November 21, 2011

Last Updated

February 5, 2019

Sponsor

Bionorica SE

1. Study Identification

Unique Protocol Identification Number

NCT01478620

Brief Title

Safety and Efficacy of Canephron® N in the Management of Uncomplicated Urinary Tract Infections (uUTI)

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 Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bionorica SE

4. Oversight

5. Study Description

Brief 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Tract Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

125 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Canephron® N

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Canephron® N

Intervention Description

3x 2 coated tablets/day for 7 days p.o.

Primary Outcome Measure Information:

Title

Incidence of Adverse Drug Reactions During 7-day Treatment of uUTI Symptoms With Canephron® N

Description

No study drug related adverse drug reactions were registered.

Time Frame

During active treatment period (day 1 until day 7)

Secondary Outcome Measure Information:

Title

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

Title

Proportion of Patients With no Symptoms Worse Than Mild on Day 7 (i.e. Responders)

Time Frame

Day 7

Title

Severity of uUTI Symptoms on Day 7

Time Frame

Day 7

Title

Severity of uUTI Symptoms on Day 37

Time Frame

Day 37

Title

Duration of uUTI Symptoms

Time Frame

During active treatment and follow up period (Day 0 - Day 37)

Title

Proportion of Patients Who Require Antibiotic Treatment Until Day 7

Time Frame

During active treatment period

Title

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)

Title

Time to First Early Recurrence [Days] After Clearance of uUTI Symptoms

Time Frame

During active treatment and follow up period (Day 0 - Day 37)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dmitry Ivanov

Organizational Affiliation

Kiev regional city hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kiev Regional City Hospital

City

Kiev

ZIP/Postal Code

04107

Country

Ukraine

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of Canephron® N in the Management of Uncomplicated Urinary Tract Infections (uUTI)

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