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).
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
125
3x 2 coated tablets/day for 7 days p.o.
Kiev Regional City Hospital
Kiev, Ukraine
Incidence of Adverse Drug Reactions During 7-day Treatment of uUTI Symptoms With Canephron® N
No study drug related adverse drug reactions were registered.
Time frame: During active treatment period (day 1 until day 7)
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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