Efficacy of Diclofenac BCG Irrigations (DIC-2011)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Carmel Medical Center.
Recruitment status was  Not yet recruiting
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
  Purpose

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 Intervention Phase
Bladder Cancer
Drug: Abitren
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: February 14, 2012
Last Updated: May 20, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by 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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2014