Efficacy of Diclofenac Suppositories in Prevention of Immediate Side Effects of BCG Bladder Irrigations. A Double Blind Placebo Controlled Randomized Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 100
- 主要终点
- Change in weekly COOP Questionnaire 1
研究概览
简要总结
This study is designed to test the effectiveness of diclofenac suppositories in the prophylaxis of side effects caused by BCG bladder irrigations in bladder cancer patients.
详细描述
This study is designed as a double blind placebo controlled randomized study to evaluate the effectiveness of diclofenac suppositories in the prevention of side effects of BCG bladder irrigation in bladder cancer patients. After signing an informed consent, the patients will be randomized to either receive an unmarked suppository of Diclofenac or a placebo suppository. The effectiveness of the drug will be tested weekly by quality of life questionnaires and bladder symptom questionnaire. Another questionnaire is designed to monitor the time in minutes that the BCG is retained in the bladder before the patients urinates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bladder urothelial carcinoma patients scheduled fo a set of 6 BCG bladder irrigations at the Carmel Medical Centre
- •Male and female
- •Patients capable of understanding reading and signing the informed consent form in Hebrew.
排除标准
- •Diclofenac hypersensitivity
- •Pregnancy, Lactation
- •Elevated creatinine at baseline (male > 1.2 mg/% female 1.0 mg/%)
- •Peptic gastric or duodenal ulcer
- •Acute or chronic inflammation of the rectum/ anus (diarrhea, rectal bleeding)
- •Gross hematuria (which is per se a contraindication for BCG irrigation)
研究组 & 干预措施
diclofenac
suppositories to prevent BCG side effects
干预措施: Abitren (Drug)
placebo suppositories
干预措施: Placebo (Drug)
结局指标
主要结局
Change in weekly COOP Questionnaire 1
时间窗: The questionnaires will be completed every week for the quality of life of the passing week. The complete time frame of all questionnaires will be 7 weeks
The bladder irrigations are delivered as an ambulatory treatment once a week. The questionnaires will be completed every week for the quality of life of the passing week.
Change in weekly COOP Questionnaire 2
时间窗: The questionnaires will be completed every week for the quality of life of the passing week. The complete time frame of all questionnaires will be 7 weeks
The bladder irrigations are delivered as an ambulatory treatment once a week. The questionnaires will be completed every week for the quality of life of the passing week.
Change in weekly COOP Questionnaire 3
时间窗: The questionnaires will be completed every week for the quality of life of the passing week. The complete time frame of all questionnaires will be 7 weeks
The bladder irrigations are delivered as an ambulatory treatment once a week. The questionnaires will be completed every week for the quality of life of the passing week.
Change in weekly Bladder symptoms Questionnaire
时间窗: The questionnaires will be completed every week for the bladder symptoms of the passing week. The complete time frame of all questionnaires will be 7 weeks
Bladder symptoms Questionnaire correlated to BCG treatment. The bladder irrigations are delivered as an ambulatory treatment once a week. The questionnaires will be completed every week for the bladder symptoms of the passing week.
Change in weekly time schedule questionnaire
时间窗: every week for 6 weeks
A questionnaire designed to measure the time in minutes that the patient was able to retain the BCG in the bladder.This questionnaire will be completed every week for the same day of weekly irrigation.
次要结局
未报告次要终点
研究者
Avi Stein, M.D.
Prof Avi Stein
Carmel Medical Center