Status:
COMPLETED
Safety and Efficacy of Canephron® N in the Management of Uncomplicated Urinary Tract Infections (uUTI)
Lead Sponsor:
Bionorica SE
Conditions:
Urinary Tract Infection
Eligibility:
FEMALE
18-65 years
Phase:
PHASE3
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 t...
Eligibility Criteria
Inclusion
- Main
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT01478620
Start Date
October 1 2011
End Date
August 1 2012
Last Update
February 27 2019
Active Locations (1)
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1
Kiev Regional City Hospital
Kiev, Ukraine, 04107