Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT01542567
Status:
UNKNOWN
Last Update Posted:
2012-05-22
First Post:
2012-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Diclofenac BCG Irrigations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'lastUpdateSubmitDate': '2012-05-20', 'studyFirstSubmitDate': '2012-02-14', 'studyFirstSubmitQcDate': '2012-03-01', 'lastUpdatePostDateStruct': {'date': '2012-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in weekly COOP Questionnaire 1', 'timeFrame': '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', '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.'}, {'measure': 'Change in weekly COOP Questionnaire 2', 'timeFrame': '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', '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.'}, {'measure': 'Change in weekly COOP Questionnaire 3', 'timeFrame': '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', '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.'}, {'measure': 'Change in weekly Bladder symptoms Questionnaire', 'timeFrame': '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', '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.'}, {'measure': 'Change in weekly time schedule questionnaire', 'timeFrame': 'every week for 6 weeks', '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diclofenac', 'BCG', 'BLADDER IRRIGATIONS'], 'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Bladder urothelial carcinoma patients scheduled fo a set of 6 BCG bladder irrigations at the Carmel Medical Centre\n2. Male and female\n3. Age 20-80.\n4. Patients capable of understanding reading and signing the informed consent form in Hebrew.\n\nExclusion Criteria:\n\n1. Diclofenac hypersensitivity\n2. Pregnancy, Lactation\n3. Elevated creatinine at baseline (male \\> 1.2 mg/% female 1.0 mg/%)\n4. Peptic gastric or duodenal ulcer\n5. Acute or chronic inflammation of the rectum/ anus (diarrhea, rectal bleeding)\n6. Gross hematuria (which is per se a contraindication for BCG irrigation)'}, 'identificationModule': {'nctId': 'NCT01542567', 'acronym': 'DIC-2011', 'briefTitle': 'Efficacy of Diclofenac BCG Irrigations', 'organization': {'class': 'OTHER', 'fullName': 'Carmel Medical Center'}, 'officialTitle': 'Efficacy of Diclofenac Suppositories in Prevention of Immediate Side Effects of BCG Bladder Irrigations. A Double Blind Placebo Controlled Randomized Study', 'orgStudyIdInfo': {'id': 'CMC-11-0015-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'diclofenac', 'description': 'suppositories to prevent BCG side effects', 'interventionNames': ['Drug: Abitren']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo suppositories', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Abitren', 'type': 'DRUG', 'description': 'SUPPOSITORIES 50 Mg 2 SUPPOSITORIES A WEEK', 'armGroupLabels': ['diclofenac']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo suppositories', 'armGroupLabels': ['placebo suppositories']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carmel Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof Avi Stein', 'investigatorFullName': 'Avi Stein, M.D.', 'investigatorAffiliation': 'Carmel Medical Center'}}}}