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


Phase 3
20 Years
80 Years
Not Enrolling
Both
Bladder Cancer

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Trial Information

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.


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

Change in weekly COOP Questionnaire 1

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:

No

Authority:

Israel: Ethics Commission

Study ID:

CMC-11-0015-CTIL

NCT ID:

NCT01542567

Start Date:

May 2012

Completion Date:

Related Keywords:

  • Bladder Cancer
  • Diclofenac
  • BCG
  • BLADDER IRRIGATIONS
  • Urinary Bladder Neoplasms

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