NCT02805452终止3 期
Impact of Solifenacin Succinate for Treatment of Acute Irritative Urinary Toxicity Occurring During Radiotherapy of Prostatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 5
- 主要终点
- Score of Urinary Symptom Profile (USP) questionnaire
研究概览
简要总结
The purpose of this study is to determine whether Succinate of Solifenacin reduces the OverActive Bladder syndrome occurring during prostate irradiation.
详细描述
A multicenter Phase III, randomized, double-blinded, parallel group placebo-controlled study.
2 groups:
- Control arm = pts. with placebo
- Experimental arm = pts. with Solifenacin succinate 5 mg - Vesicare® All patients with an OAB sub-score using the USP scale greater to 5 during prostate cancer radiotherapy will be included, receiving either a placebo or Solifenacin succinate (5mg) for duration of 3 months.
The randomization will be stratified on the radiotherapy dose (1 to 40 Gy or 40 to 70/80 Gy).
Screening:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate adenocarcinoma (histological confirmation),
- •Indication for prostate cancer radiotherapy (standard schema with a total dose from 70 to 80 Gray (GY)),
- •Patient affiliation to the French Social Security System,
- •Patient information and written informed consent,
- •Patient complaining of urinary symptoms during radiotherapy,
- •Occurrence of OverActive Bladder (OAB) subscore with the Urinary Symptom Profile (USP) scale greater or equal to 5.
排除标准
- •Prostate irradiation contraindication
- •History of bladder or prostate surgery,
- •History of of pelvic radiotherapy,
- •Individual deprived of liberty or placed Under the authority of a tutor,
- •Age < 18 years,
- •Flowmetry Qmax < 10ml/s and/or post-void residual urine > 100 ml (during urology preinclusion visit)
- •Previous known OAB
- •Patients treated with non-authorized drugs,
- •Patients treated with anticholinergic or cholinesterase inhibitors within 12 months before irradiation,
- •Patients treated with anticholinergic during and weeks following irradiation and before Succinate of Solifenacin treatment start,
- •Patients treated with botulinum toxin within 9 months before screening,
- •Patients treated with alpha-blockers, 5-alpha reductase inhibitor within 12 months preceding irradiation, during and weeks following irradiation and before Succinate of Solifenacin treatment start,
- •Contraindication of Succinate of Solifenacin
- •Hypersensitivity or allergy to Solifenacin succinate or to any other antimuscarinic agent,
- •Specific precautions of use for patients having decompensated urinary tract obstruction at risk of urinary retention, vegetative neuropathy, long QT syndrome and an hypokaliemia, history of long QT or patients at risk of QT prolongation, obstructive gastrointestinal disorders.
- •Patients treated with oral biphosphonates, drugs that cause QT prolongation or by substrates having affinity for CYP3A4 isoenzyme as verapamil and Diltiazem, or treated with CYP3A4 inductors as rifampicin, phenytoin, carbamazepine
- •Galactose hereditary intolerance, lactase deficiency or a malabsorption syndrome of glucose and galactose.
- •Patient enable to follow study medical care for family, social, geographical or psychological reasons.
- •Participation to another clinical study on urinary toxicity and/or molecule that could modify this toxicity and its evolution.
研究组 & 干预措施
Succinate of Solifenacin
Experimental
1 tablet of 5 mg of succinate of Solifenacin will be administered each day for 3 months.
干预措施: Succinate of Solifenacin (Drug)
Placebo of Succinate of Solifenacin
Placebo Comparator
1 tablet of placebo of succinate of solifenacin will be administered each day for 3 months.
干预措施: Placebo of Succinate of Solifenacin (Drug)
结局指标
主要结局
Score of Urinary Symptom Profile (USP) questionnaire
时间窗: At 6 weeks
Score will be measured after study drug treatment initiation.
次要结局
未报告次要终点
研究者
研究点 (5)
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