Clinical trial NCT01478620: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Tract Infection
Lead sponsor: Bionorica SE
Sponsor class: INDUSTRY
First posted: 2011-11-23
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence of Adverse Drug Reactions During 7-day Treatment of uUTI Symptoms With Canephron® N
timeFrame: During active treatment period (day 1 until day 7)
Secondary outcomes:
measure: 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
timeFrame: During active treatment period
measure: Proportion of Patients With no Symptoms Worse Than Mild on Day 7 (i.e. Responders)
timeFrame: Day 7
measure: Severity of uUTI Symptoms on Day 7
timeFrame: Day 7
measure: Severity of uUTI Symptoms on Day 37
timeFrame: Day 37
measure: Duration of uUTI Symptoms
timeFrame: During active treatment and follow up period (Day 0 - Day 37)
measure: Proportion of Patients Who Require Antibiotic Treatment Until Day 7
timeFrame: During active treatment period
measure: Proportion of Patients With Early Recurrence [Days] After Clearance of uUTI Symptoms
timeFrame: During active treatment and follow up period (Day 0 - Day 37)
measure: Time to First Early Recurrence [Days] After Clearance of uUTI Symptoms
timeFrame: During active treatment and follow up period (Day 0 - Day 37)
Other outcomes:
Locations:
city: Kiev
country: Ukraine
facility: Kiev Regional City Hospital
Study officials:
affiliation: Kiev regional city hospital
name: Dmitry Ivanov
role: PRINCIPAL_INVESTIGATOR
References: