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Trial Title:
Efficacy of Diclofenac BCG Irrigations
NCT ID:
NCT01542567
Condition:
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Conditions: Keywords:
Diclofenac
BCG
BLADDER IRRIGATIONS
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Abitren
Description:
SUPPOSITORIES 50 Mg 2 SUPPOSITORIES A WEEK
Arm group label:
diclofenac
Intervention type:
Drug
Intervention name:
Placebo
Description:
Placebo suppositories
Arm group label:
placebo suppositories
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.
Criteria for eligibility:
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)
Gender:
All
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
May 2012
Lead sponsor:
Agency:
Carmel Medical Center
Agency class:
Other
Source:
Carmel Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01542567
