A Pilot Study to Assess the Safety and Efficacy of Solifenacin (VESIcare) for Improving Urinary and Bladder Functions in Patients Undergoing Radiation Therapy of the Prostate
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change From Baseline to End of Study Measured by the American Urology Association Symptom Score Questionnaire (AUASS).
研究概览
简要总结
The purpose of this study is to determine if Vesicare (Solifenacin succinate) is effective in treating over-active bladder symptoms during radiation therapy of the prostate.
详细描述
This is a randomized double blind placebo controlled flexible dose 12 week study. Following screening, subjects will receive their first dose of study medication following completion of AUASS questionnaire on the first day of radiation treatment (baseline) and will continue for twelve weeks. Subjects will be started on 5 mg of study medication. The AUASS will be completed at baseline, weeks 4, 8 and 12. A 16 week visit conducted over a phone interview.
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
- 是
入选标准
- •Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent and privacy language as per HIPAA Authorization for the USA test sites is obtained from subject or legally authorized representative prior to the initiation of this study (including withdrawal of prohibited medication, if applicable)
- •Subject must be an ambulatory male at least 18 years of age.
- •Subject has been diagnosed with prostate carcinoma and has elected to undergo external beam radiation therapy.
- •Subject is willing to complete the American Urology Association Symptom Score (AUASS) Questionnaire.
排除标准
- •Subject has undergone a prostatectomy
- •Subject exhibits symptoms of urinary tract infection.
- •Subject exhibits severe neurologic damage or has undergone prostatectomy.
- •Subject diagnosed with OAB and is being treated with medication for alleviation of OAB symptoms within 12 months prior to the Screening Visit.
- •Subject has evidence of uncontrolled narrow angle glaucoma, urinary or gastric retention, neurogenic bladder; prostatitis, or persistent UTI.
- •Subject exhibits hypersensitivity to Solifenacin succinate, any ingredients, or other anticholinergic agents.
- •Subject has undergone treatment with any investigational drug within 30 days prior to screening procedure.
- •Subject has exhibited history of diagnosed gastrointestinal obstructive disease.
- •Subjects with co-morbid lower urinary tract symptoms (LUTS).
- •Subjects exhibiting clinically significant bladder outflow obstruction (BOO).
- •In the opinion of the Study Investigator, the patient has exhibited prior to the screening or Baseline visit, a clinically significant disease or medical condition that would exclude the subject from participating in the study.
- •Subjects who have received prior pelvic radiation.
- •Subjects with history of severe hepatic impairment.
- •Subjects with history of Congenital or Acquired QT prolongation.
研究组 & 干预措施
solifenacin succinate
Solifenacin succinate, 5mg or 10 mg once daily
干预措施: Solifenacin succinate (Drug)
Placebo
Drug: Placebo oral
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to End of Study Measured by the American Urology Association Symptom Score Questionnaire (AUASS).
时间窗: baseline and 16 weeks
The AUASS score range is 1-7 (mild), 8-19 (moderate) and 20-35 (severe). The AUASS asks 7 questions scored 0-5, the scores are summed for the total score.
次要结局
未报告次要终点