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

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bionorica SE

Criteria

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.