EUCTR2004-001119-69-CZ进行中（未招募）1 期
An evaluation of the dose-response relationship of Cizolirtine citrate 300 mg, twice daily, and 400 mg, twice daily, versus placebo in subjects with urge urinary incontinence.A 12-week, randomised, double-blind, placebo-controlled, multicentre study, parallel-group, Phase III clinical study with a 12 months safety follow-up period.
aboratorios Dr. Esteve, SA0 个研究点目标入组 450 人开始时间: 2004年9月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 450
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
- All
入选标准
- •1. Males and females 18 to 75 years of age.
- •2. Signed informed consent.
- •3. Subjects without any medication, or with ineffective and/or unsatisfactory current medication for OAB, specifically UUI, or subjects with a history of ineffective and/or unsatisfactory medication and currently without medication for OAB (UUI)
- •4. Subjects with a history of at least 6 months UUI.
- •The subject may be included in the study if all of the criteria at the screening visit along with all of the following criteria at the baseline visit are fulfilled:
- •5. Subjects able to co-operate
- •6. Subjects able to accurately complete the micturition diary during 7 days in the run-in period.
- •7. At least 1 urgency episode/24 h accompanied by at least one incontinence episode/24 h or in average at least 8 micturitions/24 h during 7 days within 14 days prior to the randomisation visit, as quantified from the subject’s micturition diary.
- •8. Sterile urine with absence of pyuria as confirmed by dip-stick urine test.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Stress incontinence, or any other reason for incontinence aside from urge incontinence, as determined by the investigator.
- •2. Polyuria – more than 40 mL/kg bodyweight per 24 hours.
- •3. Concomitant treatment with non-stable doses of drugs that can be supposed to have effects on the lower urinary tract such as antidepressants, neuroleptics, calcium blocking agents.
- •4. Any obstructive condition affecting the urethra or any prostatic disease, like benign hypertrophy, neoplasm, or prostatitis of clinical relevance.
- •5. Concomitant pharmacological treatment of OAB (UUI) or stress urinary incontinence with any drug different to that of the study. If the subject is using such a drug, it has to discontinued and the screening period extended to three weeks for the subject to be eligible for the study. If oestrogens are administered as treatment for UUI the dose must be stable during at least eight weeks prior to the screening visit for the subject to be eligible for the study, and continued during the study.
- •6. Urogenital surgery, such as prostatectomy or a surgical treatment of the incontinence within the last 6 months.
- •7. Concomitant conservative treatment for urinary incontinence such as vaginal cones, devices, behavioural therapy, intermittent urinary catheter, electrical stimulation etc.
- •8. Hepatic disease (defined as twice the upper limit of the reference range for liver function test).
- •9. Renal disease (defined as twice the upper limit of the reference range for creatinine).
- •10. Any history of cerebral stroke.
- •11. Manifest coronary heart disease.
- •12. Uninvestigated haematuria or haematuria secondary to malignant disease.
- •13. Interstitial cystitis (diagnosed by symptoms)
- •14. Recurrent urinary tract infections defined as four or more confirmed infections treated within 1 year before the screening visit.
- •15. Neurological disorder associated with incontinence, e.g. Parkinson’s disease and Multiple Sclerosis.
- •16. Unstable diabetes that requires changes of the treatment with either insulin or other anti diabetic agents.
- •17. Known allergy or hypersensitivity to study compound or structurally related compounds.
- •18. Participation in any other clinical study within one month prior to screening visit or previous participation in the present study.
- •19. Drug and/or alcohol abuse.
- •20. Any planned major surgery within the duration of the study.
- •21. Pregnant or nursing women, and women of childbearing potential not using reliable contraceptive methods.
- •22. Any other condition or symptoms preventing the subject from entering the study, according to the investigator’s judgement.
- •Neither will the subject be included if one of the following criteria are fulfilled at the baseline visit:
- •23. Clinically relevant abnormal values from the laboratory tests on haematology, serum chemistry and urinalysis.
- •24. Clinically relevant abnormal ECG as judged by the investigator.
- •25. Electrostimulation therapy or bladder training therapy within 2 weeks before baseline visit or planned such therapy during the study.
- •26. Any treatment with clean intermittent self catheterisation or indwelling catheter within 2 weeks before baseline visit.
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