Efficacy of Diclofenac BCG Irrigations (DIC-2011)

Israel Healthcare Foundation

Status and phase: Unknown; Phase 3

Conditions: Bladder Cancer

Treatments: Drug: Abitren; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01542567

CMC-11-0015-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

diclofenac

Active Comparator group

Description:

suppositories to prevent BCG side effects

Treatment:

Drug: Abitren

placebo suppositories

Placebo Comparator group

Treatment:

Drug: Placebo