Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT01478620
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01478620
Study Brief:
Protocol Section:
NCT01478620