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

November 21, 2011
October 10, 2014
October 2011
May 2012   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: Yes ]
No study drug related adverse drug reactions were registered.
Incidence of adverse drug reactions during 7-day treatment of uUTI symptoms with Canephron® N [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01478620 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • Proportion of Patients With no Symptoms Worse Than Mild on Day 7 (i.e. Responders) [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Severity of uUTI Symptoms on Day 7 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Severity of uUTI Symptoms on Day 37 [ Time Frame: Day 37 ] [ Designated as safety issue: No ]
  • Duration of uUTI Symptoms [ Time Frame: During active treatment and follow up period (Day 0 - Day 37) ] [ Designated as safety issue: No ]
  • Proportion of Patients Who Require Antibiotic Treatment Until Day 7 [ Time Frame: During active treatment period ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Time to First Early Recurrence [Days] After Clearance of uUTI Symptoms [ Time Frame: During active treatment and follow up period (Day 0 - Day 37) ] [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: Yes ]
  • Proportion of patients with no symptoms worse than mild on Day 7 (i.e. responders)
  • Severity of uUTI symptoms on Day 7
  • Severity of uUTI symptoms on Day 37
  • Duration of uUTI symptoms
  • Proportion of patients who require antibiotic treatment until Day 7
  • Proportion of patients with early recurrence [days] after clearance of uUTI symptoms
  • Time to first early recurrence [days] after clearance of uUTI symptoms
Not Provided
Not Provided
 
Safety and Efficacy of Canephron® N in the Management of Uncomplicated Urinary Tract Infections (uUTI)
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)

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.

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Urinary Tract Infection
Drug: Canephron® N
3x 2 coated tablets/day for 7 days p.o.
Experimental: Canephron® N
Intervention: Drug: Canephron® N
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
125
August 2012
May 2012   (final data collection date for primary outcome measure)

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.
Female
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Ukraine
 
NCT01478620
CanUTI2, 2011-000838-11
Not Provided
Bionorica SE
Bionorica SE
Not Provided
Study Chair: Yuriy Gennadyevich Alyayev, Prof. Moscow
Bionorica SE
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP