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

NCT01478620 | Completed Phase 3 Results

• 2 other identifiers: CanUTI22011-000838-11
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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).

Conditions

Urinary Tract Infection

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Drug Reactions During 7-day Treatment of uUTI Symptoms With Canephron® N

  No study drug related adverse drug reactions were registered.

  During active treatment period (day 1 until day 7)

Secondary Outcomes (8)

• 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

  During active treatment period

• Proportion of Patients With no Symptoms Worse Than Mild on Day 7 (i.e. Responders)

  Day 7

• Severity of uUTI Symptoms on Day 7

  Day 7

• Severity of uUTI Symptoms on Day 37

  Day 37

• Duration of uUTI Symptoms

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

Study Arms (1)

Canephron® N

EXPERIMENTAL

Drug: Canephron® N

Interventions

Canephron® N DRUG

3x 2 coated tablets/day for 7 days p.o.

Canephron® N

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bionorica SE: lead

Study Sites (1)

Kiev Regional City Hospital

Kiev, 04107, Ukraine

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Ivanov, Dmitry
• Organization: "Kiev regional City Hospital"

ivanovdd@i.kiev.ua

+38 (039) 247 12 36

Study Officials

• Dmitry Ivanov

  Kiev regional city hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2011
• First Posted: November 23, 2011
• Study Start: October 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 27, 2019
• Results First Posted: October 13, 2014

Record last verified: 2019-02

Locations

UA (1)