Efficacy of Diclofenac Suppositories in Prevention of Immediate Side Effects of BCG Bladder Irrigations. A Double Blind Placebo Controlled Randomized Study
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Change in weekly COOP Questionnaire 1
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.
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
No
Israel: Ethics Commission
CMC-11-0015-CTIL
NCT01542567
May 2012
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