NCT01542567

Efficacy of Diclofenac BCG Irrigations

Efficacy of Diclofenac Suppositories in Prevention of Immediate Side Effects of BCG Bladder Irrigations. A Double Blind Placebo Controlled Randomized Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Carmel Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	Abitren	SUPPOSITORIES 50 Mg 2 SUPPOSITORIES A WEEK
DRUG	Placebo	Placebo suppositories

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-05-01
• First posted: 2012-03-02
• Last updated: 2012-05-22