Efficacy of Diclofenac BCG Irrigations

Bladder Cancer Clinical Trial

— DIC-2011  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01542567
• Other study ID #: CMC-11-0015-CTIL
• Status: Not yet recruiting
• Phase: Phase 3
• First received: February 14, 2012
• Last updated: May 20, 2012
• Start date: May 2012

Study information

• Verified date: May 2012
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Bladder Cancer

Intervention

Drug:
• Abitren
SUPPOSITORIES 50 Mg 2 SUPPOSITORIES A WEEK
• Placebo
Placebo suppositories

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in weekly COOP Questionnaire 2	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
Primary	Change in weekly COOP Questionnaire 3	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
Primary	Change in weekly Bladder symptoms Questionnaire	Bladder symptoms Questionnaire correlated to BCG treatment. The bladder irrigations are delivered as an ambulatory treatment once a week. The questionnaires will be completed every week for the bladder symptoms of the passing week.	The questionnaires will be completed every week for the bladder symptoms of the passing week. The complete time frame of all questionnaires will be 7 weeks	No
Primary	Change in weekly time schedule questionnaire	A questionnaire designed to measure the time in minutes that the patient was able to retain the BCG in the bladder.This questionnaire will be completed every week for the same day of weekly irrigation.	every week for 6 weeks	No