Phase 3
N=125
Safety and Efficacy of Canephron® N in the Management of Uncomplicated Urinary Tract Infections (uUTI)
Urinary Tract Infection
Bottom Line
View on ClinicalTrials.gov: NCT01478620 ↗Enrolled (actual)
125
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Incidence of Adverse Drug Reactions During 7-day Treatment of uUTI Symptoms With Canephron® N — 0 Adverse Drug Reactions
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Canephron® N (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Bionorica SE
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Drug Reactions During 7-day Treatment of uUTI Symptoms With Canephron® N |
— | — |
| 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 |
— | — |
| SECONDARY Proportion of Patients With no Symptoms Worse Than Mild on Day 7 (i.e. Responders) |
— | — |
| SECONDARY Severity of uUTI Symptoms on Day 7 |
— | — |
| SECONDARY Severity of uUTI Symptoms on Day 37 |
— | — |
| SECONDARY Duration of uUTI Symptoms |
— | — |
| SECONDARY Proportion of Patients Who Require Antibiotic Treatment Until Day 7 |
— | — |
| SECONDARY Proportion of Patients With Early Recurrence [Days] After Clearance of uUTI Symptoms |
— | — |
| SECONDARY Time to First Early Recurrence [Days] After Clearance of uUTI Symptoms |
— | — |
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).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01478620). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.