EUCTR2004-002143-27-DE进行中（未招募）1 期
A double-blind, stratified, randomised, parallel, placebo-controlled, multi-centre study to compare the efficacy and safety of duloxetine hydrochloride (40mg twice a day) and tolterodine tartrate (XL) (4mg once daily) with placebo in patients with symptoms of Urge Urinary Incontinence
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
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. Is a female outpatient 18 years of age or over.
- •2. Have predominant urge urinary incontinence (UUI) defined as involuntary loss of urine immediately preceded by or accompanied by urgency (the complaint of a sudden compelling desire to pass urine, which is difficult to defer) without predominant SUI symptoms for 3 consecutive months prior to Visit 1.
- •3. Predominant UUI will be defined as at least 7 UUI episodes and at least twice as many UUI as SUI episodes recorded on the Stress Urge Incontinence Questionnaire (S/UIQ) at Visit 1 AND by at least 7 urge incontinence episodes per week on the screening diary completed prior to Visit 2 (see Section 11.1).
- •4. At least 10 voids per 24 hours (on a screening diary prior to Visit 2).
- •5. A urine output of less than 3000mL per 24 hours, as measured and recorded on a screening frequency volume chart (prior to Visit 2).
- •6.A negative cough stress test with a bladder volume of at least 150mL.
- •7. Is ambulatory and able to use a toilet independently and without difficulty.
- •8. Has a PVR volume less than or equal to 100mL within 15 minutes of a spontaneous void at Visit 1 documented either by ultrasound or catheterisation.
- •9. Has no language or cognitive barriers, agrees to comply with the requirements of the protocol, and has signed a written informed consent document prior to any study specific examinations/interactions are performed.
- •10. Have responded appropriately to all screening questions at Visit 1.
- •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. Pre-menopausal women (last menstruation less than 1 year prior to signing informed consent) who are:
- •a. Pregnant or have been pregnant in the last 6 months
- •b. Currently breastfeeding or have not resumed normal menstruation for 3 months due to breastfeeding
- •c. Of child-bearing potential and are NOT practicing acceptable methods of birth control.
- •2. Had continence surgery or received bladder neck bulking agent therapy, including collagen injections for incontinence, within 6 months prior to randomisation.
- •3. Has a current diagnosis ureteric, bladder, urethral, or rectal fistula, uncorrected congenital abnormality leading to urinary incontinence, voiding difficulty, including significant hesitancy or history of retention.
- •4.Has pelvic organ prolapse with protrusion of any vaginal segment greater than 1cm (> 1cm) beyond the hymen.
- •5. Had any major surgery within 3 months prior to randomisation.
- •6. Currently has, or has a history of, invasive urogenital cancer.
- •7. A history of mania or bipolar disorder.
- •8. Are judged clinically prior to randomisation to be at suicidal risk identified as a score of 2 or greater on question 9 of the BDI-II.
- •9. Active seizure disorder.
- •10. Unstable diabetes mellitus.
- •11. Known neurologic lesions or conditions or local lesions (for example, bladder stones, tumours) that could cause bladder overactivity.
- •12. Uncontrolled narrow angle glaucoma or a risk of acute narrow angle glaucoma.
- •13. Currently has, or history of ulcerative colitis or toxic mega-colon.
- •14. History of severe allergies requiring emergency medical treatment or multiple adverse drug reactions.
- •15. Risk of increased bleeding or full anticoagulation.
- •16. Monoamine oxidase inhibitors (MAOIs), SSRIs, SNRIs, tricyclic antidepressants or any other excluded medication intake within 14 days prior to randomisation.
- •17. On a medication regimen, including diuretics, where dose and/or frequency have not been stable for at least 12 weeks prior to randomisation.
- •18. Taken any medication for urge incontinence within 1 month prior to randomisation.
- •19. Currently uses any anti-incontinence device including tampons used to prevent incontinence, vaginal pessaries for prolapse or incontinence.
- •20. Had any nonpharmacologic intervention for incontinence or prolapse within 3 months of randomisation.
- •21. Known active substance abuse disorder within the 5 years prior to randomisation or reports regular consumption of 21 or more units of alcohol per week.
- •22. Any active cardiac ischaemic condition, including myocardial infarction within 6 months prior to randomisation.
- •23. Uncontrolled or poorly controlled hypertension.
- •24. A symptomatic arrhythmia despite antiarrhythmic medication, uncontrolled angina, or a significant abnormality on ECG
- •25. Acute liver injury or severe cirrhosis (Child-Pugh Class C).
- •26. Hepatic dysfunction as defined by the following laboratory parameters:
- •a. SGPT (ALT) or SGOT (AST) greater than or equal to 3 times upper limit of normal (ULN)
- •b. Bilirubin greater than or equal to 1.5 times ULN
- •27. A positive urine culture (> 100,000 cfu/mL) at Visit 1, or a history of 4 or more urinary tract infections (UTIs) in the preceding year as determined by the clinical investigator.
- •28. Known severe renal impairment as defined by creatinine clearance < 30mL/min.
- •29. Known hypersensitivity to duloxetine, tolterodine or any of its inactive ingredients.
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