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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bionorica SE
ClinicalTrials.gov Identifier:
NCT01478620
First received: November 21, 2011
Last updated: October 10, 2014
Last verified: October 2014
Results First Received: August 27, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Urinary Tract Infection
Intervention: Drug: Canephron® N

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Canephron® N 3x 2 coated tablets/day for 7 days p.o.

Participant Flow:   Overall Study
    Canephron® N  
STARTED     125  
COMPLETED     119  
NOT COMPLETED     6  
Lost to Follow-up                 6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Canephron® N 3x 2 coated tablets/day for 7 days p.o.

Baseline Measures
    Canephron® N  
Number of Participants  
[units: participants]
  125  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     123  
>=65 years     2  
Gender, Customized [1]
[units: participants]
  125  
Region of Enrollment  
[units: participants]
 
Ukraine     125  
Russian Federation     0  
Study-Specific Measure [2]
[units: score on a scale]
Mean ± Standard Deviation
  7.3  ± 1.25  
[1] female participants
[2]

The severity of uUTI symptoms was assessed daily by the patient as well as by the investigator at each study visit. The following uUTI symptoms were rated on a 5-point scale: dysuria, frequency, urgency, acute development of incontinence or worsening of incontinence, nocturia, pain or discomfort in lower abdomen or pelvic areas and increased body temperature.

The assessment of the symptoms ranged from 0 (absent or </= 37°C) to 4 (very severe or >/= 40°C).

At baseline the total sum score (sum of subscales) of the symptoms dysuria, frequency and urgency had to be at least >/= 6.




  Outcome Measures

1.  Primary:   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) ]

2.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Proportion of Patients With no Symptoms Worse Than Mild on Day 7 (i.e. Responders)   [ Time Frame: Day 7 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Severity of uUTI Symptoms on Day 7   [ Time Frame: Day 7 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Severity of uUTI Symptoms on Day 37   [ Time Frame: Day 37 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Duration of uUTI Symptoms   [ Time Frame: During active treatment and follow up period (Day 0 - Day 37) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Proportion of Patients Who Require Antibiotic Treatment Until Day 7   [ Time Frame: During active treatment period ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   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) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Time to First Early Recurrence [Days] After Clearance of uUTI Symptoms   [ Time Frame: During active treatment and follow up period (Day 0 - Day 37) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Ivanov, Dmitry
Organization: "Kiev regional City Hospital"
phone: +38 (039) 247 12 36
e-mail: ivanovdd@i.kiev.ua


No publications provided


Responsible Party: Bionorica SE
ClinicalTrials.gov Identifier: NCT01478620     History of Changes
Other Study ID Numbers: CanUTI2, 2011-000838-11
Study First Received: November 21, 2011
Results First Received: August 27, 2014
Last Updated: October 10, 2014
Health Authority: Ukraine: Ministry of Health
Russia: Ministry of Health of the Russian Federation