EUCTR2004-002640-97-IS进行中（未招募）不适用
Time to onset of action of tolterodine using force fill cystometry in SPINAL CORD INJURY PATIENTS WITH neurogenic detrusor overactivity. - NA
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
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.Male or female patients aged 18-65 years, with urodynamic evidence of neurogenic detrusor overactivity (phasic or uninhibited detrusor contraction) arising as a consequence of spinal cord injury or pathology.
- •2.Evidence of phasic uninhibited detrusor contraction on fast fill cystometry at the beginning of Period 1.
- •3.Demonstrable provoked uninhibited detrusor contraction following force fill at the beginning of Period 1.
- •4.Subjects capable of understanding and giving written informed consent after full discussion concerning the nature of the research.
- •5.Female subjects must have a negative pregnancy test.
- •6.Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
- •7.Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Subjects who do not provide written consent to participate in the study
- •2.Subjects who have a medical condition that would impair their ability to participate reliably in the study.
- •3.Subjects who are pregnant or lactating.
- •4.Subjects with a recent history of autonomic dysreflexia (AD) or AD which is associated with urodynamic investigations
- •5.Treatment within 7 days (or 5x plasma half-life, if longer) preceding the study, or expected to start treatment during the study with:
- •a.anticholinergic drugs
- •b.drugs with significant anticholinergic effects such as tricyclic antidepressants
- •c.drug treatment for overactive bladder. Estrogen treatment initiated more than 2 months prior to randomization is allowed.
- •6.Use of inhibitors of the metabolism of tolterodine:
- •a.Potent cytochrome P450 3A4 inhibitors such as macrolide antibiotics (erythromycin and clarithromycin), antifungal agents (ketoconazole and itraconazole), cimetidine, MAOIs, and protease inhibitors. Drugs and/or herbal preparations capable of inducing hepatic enzyme metabolism (e.g., barbiturates, rifampin, carbamazepine, phenytoin, primidone or St. John’s Wort). These must be discontinued within 30 days (or 5 half-lives of inducing/inhibiting agent, whichever is longer) of enrollment in the study.
- •b.Fluoxetine must be discontinued at least 5 weeks before first dose of study medication.
- •c.Have consumed grapefruit or grapefruit-containing products within 7 days prior to the first dose of study medication
- •7.Subject on a variable dosage of any drug with anticholinergic side effects, or subject expected to start such treatment during the study.
- •8.Have a known history of hypersensitivity, allergy, severe adverse drug reaction or intolerance to anticholinergic drugs, including tolterodine.
- •9.Have contraindications to the use of anticholinergic drugs, e.g., uncontrolled narrow-angle glaucoma, urinary retention, significant urinary outflow obstruction (not including sphincter dyssynergia), gastric retention. Significant urinary outflow obstruction is defined as being a urinary pressure/flow study in the obstructed range of the Abrams/Griffiths nomogram or a maximum urinary flow rate <15 mL/sec.
- •10.Subjects who have evidence of alcohol abuse or abuse of controlled substances.
- •11.Subject who has received any electrostimulation or bladder retraining within the three months before randomization, or is expected to start such therapy during the study period.
- •12.Chronic persistent local pathology that may lead to urinary symptoms e.g. urinary tract infection, marked cystocele or pelvic prolapse, interstitial cystitis, bladder stones, unexplained hematuria (> 1+ on dipstick test unless fully investigated prior to randomization to exclude significant urological disease).
- •13.Have a clinically significant ECG abnormality at screening, except those with non-clinically significant sinus tachycardia or sinus bradycardia. Screening 12-lead ECG demonstrating QTC>430 msec (males) and QTc>450 msec (females).
- •14.History or evidence of major hematological, renal or hepatic abnormalities (subjects with clinically significant hepatic (Child Pugh C classification) or significant renal impairment serum creatinine 3xULN).
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