Efficacy of Diclofenac BCG Irrigations (DIC-2011)

This study is not yet open for participant recruitment.

Verified May 2012 by Carmel Medical Center

Sponsor:

Information provided by (Responsible Party):

Avi Stein, M.D., Carmel Medical Center

ClinicalTrials.gov Identifier:

NCT01542567

First received: February 14, 2012

Last updated: May 20, 2012

Last verified: May 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 14, 2012
Last Updated Date	May 20, 2012
Start Date ^ICMJE	May 2012
Estimated Primary Completion Date	May 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 4, 2012)	Change in weekly COOP Questionnaire 1 [ 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 ] [ Designated as safety issue: No ] 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. Change in weekly COOP Questionnaire 2 [ 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 ] [ Designated as safety issue: No ] 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. Change in weekly COOP Questionnaire 3 [ 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 ] [ Designated as safety issue: No ] 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. Change in weekly Bladder symptoms Questionnaire [ Time Frame: 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 ] [ Designated as safety issue: No ] 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. Change in weekly time schedule questionnaire [ Time Frame: every week for 6 weeks ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE (submitted: March 1, 2012)	Weekly COOP Questionnaire 1 [ 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 ] [ Designated as safety issue: No ] 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. Weekly COOP Questionnaire 2 [ 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 ] [ Designated as safety issue: No ] 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. Weekly COOP Questionnaire 3 [ 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 ] [ Designated as safety issue: No ] 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. Weekly Bladder symptoms Questionnaire [ Time Frame: 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 ] [ Designated as safety issue: No ] 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. Weekly time schedule questionnaire [ Time Frame: every week for 6 weeks ] [ Designated as safety issue: No ] 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.
Change History	Complete list of historical versions of study NCT01542567 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy of Diclofenac BCG Irrigations
Official Title ^ICMJE	Efficacy of Diclofenac Suppositories in Prevention of Immediate Side Effects of BCG Bladder Irrigations. A Double Blind Placebo Controlled Randomized Study
Brief 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.
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 ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
Condition ^ICMJE	Bladder Cancer
Intervention ^ICMJE	Drug: Abitren SUPPOSITORIES 50 Mg 2 SUPPOSITORIES A WEEK Drug: Placebo Placebo suppositories
Study Arm (s)	Active Comparator: diclofenac suppositories to prevent BCG side effects Intervention: Drug: Abitren Placebo Comparator: placebo suppositories Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	100
Completion Date	Not Provided
Estimated Primary Completion Date	May 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Bladder urothelial carcinoma patients scheduled fo a set of 6 BCG bladder irrigations at the Carmel Medical Centre Male and female Age 20-80. Patients capable of understanding reading and signing the informed consent form in Hebrew. Exclusion Criteria: Diclofenac hypersensitivity Pregnancy, Lactation Elevated creatinine at baseline (male > 1.2 mg/% female 1.0 mg/%) Peptic gastric or duodenal ulcer Acute or chronic inflammation of the rectum/ anus (diarrhea, rectal bleeding) Gross hematuria (which is per se a contraindication for BCG irrigation)
Gender	Both
Ages	20 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01542567
Other Study ID Numbers ^ICMJE	CMC-11-0015-CTIL
Has Data Monitoring Committee	No
Responsible Party	Avi Stein, M.D., Carmel Medical Center
Study Sponsor ^ICMJE	Carmel Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Carmel Medical Center
Verification Date	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top