EUCTR2013-004529-99-DE进行中（未招募）1 期
A double-blind, controlled, parallel-group, randomized, multicenter clinical trial to assess the efficacy and safety of a herbal drug containing centaury, lovage root, and rosemary leaf (CLR) in comparison to fosfomycin trometamol for the treatment of acute lower uncomplicated urinary tract infections (uUTIs) in women
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bionorica SE
- 入组人数
- 644
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •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
排除标准
- •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.
研究者
相似试验
进行中（未招募）
1 期
Assess Safety and Efficacy of Vilaprisan in Subjects with Uterine FibroidseiomyomaMedDRA version: 20.0Level: LLTClassification code 10046784Term: Uterine fibroidsSystem Organ Class: 100000021126MedDRA version: 20.0Level: LLTClassification code 10016628Term: FibroidsSystem Organ Class: 100000021126MedDRA version: 20.0Level: LLTClassification code 10022794Term: Intramural leiomyoma of uterusSystem Organ Class: 100000021126EUCTR2016-002855-48-BEBayer AG996
进行中（未招募）
1 期
Assess Safety and Efficacy of Vilaprisan in Subjects with Uterine FibroidseiomyomaMedDRA version: 19.1 Level: LLT Classification code 10046784 Term: Uterine fibroids System Organ Class: 100000004864MedDRA version: 20.0 Level: LLT Classification code 10016628 Term: Fibroids System Organ Class: 100000004864MedDRA version: 20.0 Level: LLT Classification code 10022794 Term: Intramural leiomyoma of uterus System Organ Class: 100000004864EUCTR2016-002855-48-ESBayer AG996
进行中（未招募）
1 期
Assess Safety and Efficacy of Vilaprisan in Subjects with Uterine FibroidseiomyomaMedDRA version: 19.1Level: LLTClassification code 10046784Term: Uterine fibroidsSystem Organ Class: 100000004864MedDRA version: 19.1Level: LLTClassification code 10016628Term: FibroidsSystem Organ Class: 100000004864MedDRA version: 19.1Level: LLTClassification code 10022794Term: Intramural leiomyoma of uterusSystem Organ Class: 100000004864EUCTR2016-002855-48-HUBayer AG996
进行中（未招募）
1 期
Assess Safety and Efficacy of Vilaprisan in Subjects with Uterine FibroidsleiomyomaEUCTR2016-002855-48-ITBAYER HEALTHCARE AG996
进行中（未招募）
不适用
A randomized, double-blind, parallel group, single-dose study of the efficacy of lidocaine 8 mg + cetylpyridinium chloride (CPC) 2 mg fixed combination lozenges on sore throat pain intensity compared to Mebucaine CL lozenges (containing lidocaine 1 mg and CPC 2 mg) in subjects with sore throat due to upper respiratory tract infectioSore throat due to upper respiratory tract infection(Planned indication for approval:Local antiseptic and analgesic treatment of sore throat and minor infections of the mouth.Relief of pain as well as irritation associated with these conditions in adults and adolescents aged 12 years and above.)MedDRA version: 12.1Level: LLTClassification code 10041367Term: Sore throatMedDRA version: 12.1Level: LLTClassification code 10068319Term: Oropharyngeal painEUCTR2010-021653-39-DEovartis Consumer Health S.A.