EUCTR2012-004898-30-IT进行中（未招募）不适用
ong-term Extension Study of BOTOX® in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 8 to 17 Years of Age
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
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. patient was aged = 8 years to = 17 years of age at the time of informed consent for the preceding study, 191622-120
- •2. patient has participated in Study 191622-120 and fulfilled that study’s exit criteria (completed the qualification for retreatment/exit visit or the week 48/exit visit if they never qualified for retreatment)
- •3. written informed consent has been obtained from the legally authorized representative and written minor assent has been obtained, in accordance with local laws and institutional review board (IRB)/independent ethics committee (IEC) requirements
- •4. written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information [United States sites] and written Data Protection consent [European sites])
- •5. patient must be regularly using CIC to empty the bladder (CIC can be performed by either the patient or the parent/caregiver)
- •6. negative urine pregnancy test for females who are postmenarche
- •7. patient is able to complete study requirements including completion of bladder diaries and HRQOL questionnaires (these can also be completed by the parent/caregiver), and is likely to attend study visits in the opinion of the investigator
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •F.1.2 Adults (18-64 years) no
- •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. patient has experienced an adverse event in the preceding study, 191622-120, that may indicate an unacceptable safety risk for additional BOTOX treatments, in the investigator’s opinion
- •2. patient has experienced a treatment-related serious adverse event in the preceeding study, 191622-120
- •3. investigator deems that, based on the patient’s response to the treatment received in study 191622-120, a dose reduction would be warranted for a subsequent treatment
- •4. patient has a newly diagnosed uncontrolled systemic disease, cancer or malignant disease, or uncontrolled epilepsy
- •5. patient has any newly diagnosed medical condition that may put them at increased risk with exposure to BOTOX including myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
- •6. patient currently uses or plans to use a baclofen pump
- •7. patient currently uses or plans to use an implantable or nonimplantable electrostimulation/neuromodulation device for the treatment of NDO
- •8. patient currently uses or plans to use an indwelling catheter for treatment of NDO
- •9. patient has known allergy or sensitivity to components of any botulinum toxin preparation (including the study medication preparation), anesthetics or antibiotics to be used during the study
- •10. patient cannot withhold any antiplatelet, anticoagulant therapy or medications with anticoagulant effects for 3 days prior to treatment. Note: some medications may need to be withheld for > 3 days, per clinical judgment of the investigator (see Section 4.5.2, Prohibited Medications/Treatments for additional details).
- •11. patient has had previous botulinum toxin therapy of any serotype for any urological condition (other than the study medication) or for any nonurological condition since entry into the preceding study, 191622-120
- •12. postmenarche female patients who are pregnant, nursing, or planning to become pregnant during the study (postmenarche female patients must also either be sexually abstinent or use another acceptable form of contraception – see Section 4.5.1.1)
- •13. current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study (or longer if local requirements specify) other than Study 191622-120
- •14. patient has a condition or is in a situation which in the investigator’s opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient’s participation in the study
研究者
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