Efficacy of Diclofenac BCG Irrigations (DIC-2011)

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 to test the effectiveness of diclofenac suppositories in the prophylaxis of side effects caused by BCG bladder irrigations in bladder cancer patients.

Study Overview

• Status: Unknown
• Conditions: Bladder Cancer
• Intervention / Treatment: Drug: Abitren; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: diclofenac; suppositories to prevent BCG side effects	Drug: Abitren; SUPPOSITORIES 50 Mg 2 SUPPOSITORIES A WEEK
Placebo Comparator: placebo suppositories	Drug: Placebo; Placebo suppositories

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Carmel Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Anticipated): May 1, 2014

Study Registration Dates

• First Submitted: February 14, 2012
• First Submitted That Met QC Criteria: March 1, 2012
• First Posted (Estimate): March 2, 2012

Study Record Updates

• Last Update Posted (Estimate): May 22, 2012
• Last Update Submitted That Met QC Criteria: May 20, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: BCG; Diclofenac; BLADDER IRRIGATIONS
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: CMC-11-0015-CTIL