Efficacy of a herbal drug called CLR” compared to the antibiotic fosfomycin trometamol” in acute lower urinary tract infections

Phase 1

• Conditions: Acute lower uncomplicated urinary tract infection; MedDRA version: 20.0Level: LLTClassification code 10024981Term: Lower urinary tract infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-004529-99-DE
• Lead Sponsor: Bionorica SE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-17
• Last Update Posted: 14 May 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 644

Inclusion Criteria

1. Signed informed consent (IC) and data protection declaration.
2. Female outpatients aged 18 to 70 years.
3. Sum-score of the three main uUTI symptoms (dysuria [feeling pain or burning when passing urine”, No.3], pollakisuria [frequent urination of small volumes of urine”, No. 1], and urgency [Urgent urination”, No. 2]) reported on the ACSS-”Typical” domain at Visit 1 is =6.
4. Symptoms of the acute episode of lower uUTI are developed within not more than 6 days prior to Visit 1.
5. Leukocyturia at Visit 1, confirmed by positive dipstick
6. Patients willing to refrain from consuming prohibited concomitant medications and products
7. Non-lactating female patients who are surgically sterile (have had a documented sterilization, bilateral oophorectomy at least 3 months before the start of the trial and/or hysterectomy), or postmenopausal (cessation of menses for at least 12 months), or women of childbearing potential with a negative pregnancy test at Visit 1 willing to use highly effective (failure rate less than 1% per year, i.e., Pearl Index <1) contraception methods, e.g., contraceptive patch, oral, injected or implanted hormonal methods of contraception, during the trial including the follow-up period.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 483
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 161

Exclusion Criteria

1. Any signs of complicated UTIs, pyelonephritis (i.e., fever T =38.0°C [grade 2], flank and/or back pain, chills and shivers), and/or vulvo-vaginitis with vaginal and/or with urethral discharge (without urination) at Visit 1.
2. Any conditions that may lead to complicated infections (i.e., renal diseases, urinary tract abnormalities or past urinary surgery, urine catheterization, uncontrolled diabetes mellitus, spinal cord injury, etc.).
3. Chronic infection of the urinary tract known from medical history.
4. Persisting signs or symptoms of severe, progressive, or uncontrolled systemic disease (i.e., renal, hepatic, biliary, hematological, gastro-intestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease).
5. Uncontrolled hypertension (a diastolic blood pressure >95 mmHg at Visit 1).
6. Known severe cardiac insufficiency, coronary heart disease, valvular heart disease, cardiac arrhythmia, QT interval prolongation or other severe cardiac disease at Visit 1.
7. Any antibiotic therapy within 30 days prior to Visit 1.
8. Other acute infections (except uUTIs) requiring antibiotic treatment at Visit 1.
9. Patients receiving treatment for suspected or confirmed UTI (antibiotic or phytopharmaceutical) within 30 days prior to Visit 1.
10. Patients who took anti-inflammatory or analgesic drugs (e.g. ibuprofen, paracetamol, acetylsalicylic acid) or spasmolytics for any reason within 24 hours prior to Visit 1, and/or are not willing to stop the intake of any of the following medication not permitted for use during the trial: Rosmarini folium, Levistici radix, and Centaurii herba supplements other than the CLR (IMP), anti-inflammatory or analgesic drugs (e.g. ibuprofen, acetylsalicylic acid, with exception of paracetamol), spasmolytics, herbal drugs or supplements, cranberry juice, and kidney or bladder teas.
11. Known severe impaired renal function (creatinine clearance <20 mL/min).
13. Active peptic ulcers.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate non-inferiority of a non-antibiotic therapy with CLR versus an antibiotic treatment with fosfomycin trometamol in women suffering from acute lower uUTIs as measured by the proportion of patients who received an additional antibiotic treatment for acute lower uUTIs during the trial.;Secondary Objective: The secondary objective of this trial is to provide further efficacy data supporting the primary efficacy analysis and assess safety and tolerability of CLR for the treatment of acute lower uUTIs.;Primary end point(s): The primary efficacy endpoint is the intake of any additional antibiotic medication for acute lower uUTIs between Visit 1 and Visit 4.;Timepoint(s) of evaluation of this end point: See E.5.1