Efficacy of Diclofenac BCG Irrigations (DIC-2011)
This study is not yet open for participant recruitment.
Verified May 2012 by Carmel Medical Center
Sponsor:
Carmel Medical Center
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
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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:
- 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)
Contacts and Locations
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 May 23, 2013