Efficacy of Diclofenac BCG Irrigations

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Carmel Medical Center
• Treatments: Diclofenac

Criteria

Inclusion Criteria:

1. Bladder urothelial carcinoma patients scheduled fo a set of 6 BCG bladder irrigations at the Carmel Medical Centre

2. Male and female

3. Age 20-80.

4. Patients capable of understanding reading and signing the informed consent form in Hebrew.

Exclusion Criteria:

1. Diclofenac hypersensitivity

2. Pregnancy, Lactation

3. Elevated creatinine at baseline (male > 1.2 mg/% female 1.0 mg/%)

4. Peptic gastric or duodenal ulcer

5. Acute or chronic inflammation of the rectum/ anus (diarrhea, rectal bleeding)

6. Gross hematuria (which is per se a contraindication for BCG irrigation)