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Efficacy of Diclofenac BCG Irrigations (DIC-2011)

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ClinicalTrials.gov Identifier: NCT01542567
Recruitment Status : Unknown
Verified May 2012 by Avi Stein, M.D., Carmel Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 2, 2012
Last Update Posted : May 22, 2012
Sponsor:
Information provided by (Responsible Party):
Avi Stein, M.D., Carmel Medical Center

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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: Abitren Drug: Placebo Phase 3

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy of Diclofenac Suppositories in Prevention of Immediate Side Effects of BCG Bladder Irrigations. A Double Blind Placebo Controlled Randomized Study
Study Start Date : May 2012
Estimated Primary Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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.

  3. 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 ]
    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.

  4. 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 ]
    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.

  5. Change in weekly time schedule questionnaire [ Time Frame: every week for 6 weeks ]
    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.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Responsible Party: Avi Stein, M.D., Prof Avi Stein, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01542567     History of Changes
Other Study ID Numbers: CMC-11-0015-CTIL
First Posted: March 2, 2012    Key Record Dates
Last Update Posted: May 22, 2012
Last Verified: May 2012

Keywords provided by Avi Stein, M.D., Carmel Medical Center:
Diclofenac
BCG
BLADDER IRRIGATIONS

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action