ACTRN12610001093077招募中不适用
Comparison of THVD-201, a Combination of Tolterodine and a Muscarinic Agonist vs. Tolterodine Alone vs. Placebo to measure the tolerability in Subjects with Overactive Bladder (OAB) Symptoms(Protocol No.: THVD-201-002)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- Female
入选标准
- •1. Females 18-75 years
- •2. Subject has a history of OAB (pure urge or mixed urinary incontinence with predominant urge incontinence) for equal to 6 months.
- •Subject who is currently taking IR tolterodine (2 mg bid) for at least 5 weeks and who is considered to be a responder to this therapy (see below for number of micturitions and incontinence episodes per day). Depending on the anti-muscarinic treatment at screening, all subjects will need to have completed at least 1 to 5 weeks of 2 mg bid IR tolterodine prior to starting the baseline diary o Subjects may be converted from extended release tolterodine (at least 4 weeks of 4 mg QD) to tolterodine IR (2 mg bid) for at least 1 week prior to the start of the baseline diary.
- •Subjects may be converted from a non-tolterodine OAB treatment to IR tolterodine (2 mg bid) for at least 5 weeks prior to initiation of the baseline diary.
- •Subjects taking IR tolterodine 1 mg bid need to be treated with 2 mg bid tolterodine for at least 5 weeks prior to starting the baseline diary.
- •3. Subject meets the following criteria, based on the voiding and dry mouth VAS diary
- •Urinary frequency less than 13 micturitions per day, as recorded in the subject diary with or without symptoms of urgency (i.e., sudden desire to micturate)
- •Less than 4 incontinence episodes over a 3-day period
- •VAS equal to or greater than 35 mm on a 100 mm scale for dry mouth
- •4. Subject is able and willing to correctly and independently complete the subject voiding diaries and VAS assessments for 3 consecutive days during the week before Visits 2, 3, 4 and 5.
- •5. Subject is able to use toilet without assistance
- •6. Subject of childbearing potential must have a negative pregnancy test prior to enrollment and should not be breast-feeding. All pre-menopausal subjects must be using a highly effective method of birth control during the study and for at least one month following the last dose of study medication. (Menopause defined as at least one year without menses.) A highly effective method of birth control is defined as one that results in a low failure rate (i.e., less than 1 percent per year) when used consistently and correctly, such as contraceptive implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence, or a vasectomized partner.
- •7. Subject is willing and able to consent to participate by signing an informed consent form following an explanation of the nature and purpose of this study.
排除标准
- •1. Subjects with predominate stress incontinence, insensate incontinence (those incapable of distinguishing discrete incontinence episodes) and overflow incontinence, as major reason for urine loss or urinary frequency as determined by the investigator
- •2. Subjects with history of neurogenic bladder
- •3. Subjects with clinically significant renal disease (estimated creatinine clearance defined by Cockcroft and Gault formula less than 30 ml per min)
- •4. Subject has elevated serum transaminases (ALT or AST greater than 1.3 times the upper limit of normal for the laboratory conducting the test) and no history of hepatic dysfunction
- •5. Subjects with uninvestigated haematuria
- •6. Subjects who develop acute urinary tract infections (UTI) during the baseline period following a negative urinalysis at screening visit, or subjects with recurrent UTI defined as receiving treatment for symptomatic UTI more than 2 times in the past year
- •7. Subjects with indwelling catheter or requiring intermittent catheterization
- •8. Subjects with bladder or lower urinary tract surgeries performed within the past 6 months, or those who had surgeries leading to complications such as fistula
- •9. Subjects diagnosed with bladder cancer, interstitial cystitis, or painful bladder syndrome within the past 6 months
- •10. Subjects taking diuretics or oestrogen therapy that was not part of a long-term stable program of at least 6 months
- •11. Subjects starting bladder retraining per bladder drill programs
- •12. Subjects who were anticipated to begin or change other bladder therapies (non-medicinal) such as biofeedback or kegels, during the course of the study
- •13. Subjects with malignancy within the past 6 months or prior pelvic malignancies requiring radiation therapy or whose surgery had led to complications such as fistulas, etc
- •14. Subjects with a history or presence of tachyarrhythmias or cardiac disease that in the opinion of the investigator might confound the results of the study or pose additional risk to the subject. Subjects with QTc greater than 470 msec should not be enrolled.
- •15. Subjects taking any medications that may interfere with lower urinary tract function or dry mouth, or affect the subject's suitability and r or effective participation in the trial (i.e., drugs that may have anti-muscarinic or anti-histaminic activity or induce or inhibit cytochrome P450 2D6 enzyme).
- •16. Subjects with the history or current untreated narrow angle glaucoma
- •17. Subjects with the history or current myasthenia gravis
- •18. Subjects with known or suspected biliary tract disease, active nephrolithiasis, cognitive or psychiatric disturbances, gastric retention, urinary retention, uncontrolled ulcerative colitis, toxic megacolon or other known medical condition, which in the opinion of the investigator would compromise the subject’s ability to participate in this trial (e.g., progressive malignant disease, HIV infection, major surgery within last 4 weeks).
- •19. Subjects with a history of chronic alcohol or drug abuse within last 6 months
- •20. Subjects with post void residual urine volume > 100 mL (non-invasive bladder scan)
- •21. Subject with known polyuria (3 L per day)
- •22. Subjects who drink grapefruit juice daily
- •23. Subjects with hypersensitivity to the components of the tolterodine and THVD-201 formulation
- •24. Subjects participating in another clinical trial or receiving a non-approved drug less than 30 days prior to the screening visit.
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