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Efficacy of Diclofenac BCG Irrigations (DIC-2011)

Primary Purpose

Bladder Cancer

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Abitren
Placebo
Sponsored by
Carmel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bladder Cancer focused on measuring Diclofenac, BCG, BLADDER IRRIGATIONS

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    diclofenac

    placebo suppositories

    Arm Description

    suppositories to prevent BCG side effects

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 14, 2012
    Last Updated
    May 20, 2012
    Sponsor
    Carmel Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01542567
    Brief Title
    Efficacy of Diclofenac BCG Irrigations
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2012
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2012 (undefined)
    Primary Completion Date
    May 2014 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Carmel Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bladder Cancer
    Keywords
    Diclofenac, BCG, BLADDER IRRIGATIONS

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    diclofenac
    Arm Type
    Active Comparator
    Arm Description
    suppositories to prevent BCG side effects
    Arm Title
    placebo suppositories
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Abitren
    Intervention Description
    SUPPOSITORIES 50 Mg 2 SUPPOSITORIES A WEEK
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo suppositories
    Primary Outcome Measure Information:
    Title
    Change in weekly COOP Questionnaire 1
    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.
    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
    Title
    Change in weekly COOP Questionnaire 2
    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.
    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
    Title
    Change in weekly COOP Questionnaire 3
    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.
    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
    Title
    Change in weekly Bladder symptoms Questionnaire
    Description
    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.
    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
    Title
    Change in weekly time schedule questionnaire
    Description
    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.
    Time Frame
    every week for 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy of Diclofenac BCG Irrigations

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