Trial Outcomes & Findings for Safety and Efficacy of Canephron® N in the Management of Uncomplicated Urinary Tract Infections (uUTI) (NCT NCT01478620)

Results Overview

No study drug related adverse drug reactions were registered.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

125 participants

Primary outcome timeframe

During active treatment period (day 1 until day 7)

Results posted on

2019-02-27

Participant Flow

Participant milestones

Participant milestones
Measure	Canephron® N 3x 2 coated tablets/day for 7 days p.o.
Overall Study STARTED	125
Overall Study COMPLETED	119
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Canephron® N 3x 2 coated tablets/day for 7 days p.o.
Overall Study Lost to Follow-up	6

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Canephron® N n=125 Participants 3x 2 coated tablets/day for 7 days p.o.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	123 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex/Gender, Customized	125 participants n=5 Participants
Region of Enrollment Ukraine	125 participants n=5 Participants
uncomplicated urinary tract infection symptom score	7.3 score on a scale STANDARD_DEVIATION 1.25 • n=5 Participants

PRIMARY outcome

Timeframe: During active treatment period (day 1 until day 7)

No study drug related adverse drug reactions were registered.

Outcome measures

Outcome measures
Measure	Canephron® N n=125 Participants 3x 2 coated tablets/day for 7 days p.o.
Incidence of Adverse Drug Reactions During 7-day Treatment of uUTI Symptoms With Canephron® N	0 Adverse Drug Reactions

SECONDARY outcome

Timeframe: During active treatment period

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 7

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 7

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 37

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During active treatment period

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Outcome measures

Outcome data not reported

Adverse Events

Canephron® N

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Canephron® N n=125 participants at risk 3x 2 coated tablets/day for 7 days p.o.
Nervous system disorders Headache	4.0% 5/125 • Number of events 9
Gastrointestinal disorders Abdominal distension	1.6% 2/125 • Number of events 2
Gastrointestinal disorders Nausea	0.80% 1/125 • Number of events 1
Infections and infestations Pharyngitis	0.80% 1/125 • Number of events 1
Infections and infestations Respiratory tract infection	0.80% 1/125 • Number of events 1
Infections and infestations Rhinitis	0.80% 1/125 • Number of events 1
Investigations Blood pressure increased	0.80% 1/125 • Number of events 1
Investigations Heart rate irregular	0.80% 1/125 • Number of events 1
Blood and lymphatic system disorders Anaemia	0.80% 1/125 • Number of events 1
Psychiatric disorders Insomnia	0.80% 1/125 • Number of events 1
Vascular disorders Hypertension	0.80% 1/125 • Number of events 4

Additional Information

Ivanov, Dmitry

"Kiev regional City Hospital"

Phone: +38 (039) 247 12 36

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Each Party acknowledges that it shall not publish any results of the trial,without the prior written authorization of the other Party. If SPONSOR (S.) requests INVESTIGATOR (I.)to publish any results obtained from the study, I. shall prepare and accomplish such publication at the expense of S. after review by S. and subject to written approval of the S. prior to publication. I. must be mentioned as co-author in any kind of publication resulting from such a request by S. to I. to publish.
Publication restrictions are in place

Restriction type: OTHER