- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01478620
Safety and Efficacy of Canephron® N in the Management of Uncomplicated Urinary Tract Infections (uUTI)
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 Overview
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Kiev, Ukraine, 04107
- Kiev Regional City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Canephron® N
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3x 2 coated tablets/day for 7 days p.o.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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No study drug related adverse drug reactions were registered.
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During active treatment period (day 1 until day 7)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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During active treatment period
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Proportion of Patients With no Symptoms Worse Than Mild on Day 7 (i.e. Responders)
Time Frame: Day 7
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Day 7
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Severity of uUTI Symptoms on Day 7
Time Frame: Day 7
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Day 7
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Severity of uUTI Symptoms on Day 37
Time Frame: Day 37
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Day 37
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Duration of uUTI Symptoms
Time Frame: During active treatment and follow up period (Day 0 - Day 37)
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During active treatment and follow up period (Day 0 - Day 37)
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Proportion of Patients Who Require Antibiotic Treatment Until Day 7
Time Frame: During active treatment period
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During active treatment period
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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)
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During active treatment and follow up period (Day 0 - Day 37)
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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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During active treatment and follow up period (Day 0 - Day 37)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dmitry Ivanov, Kiev Regional City Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CanUTI2
- 2011-000838-11 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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