Clinical trial · Interventional
Efficacy of Diclofenac BCG Irrigations
Efficacy of Diclofenac Suppositories in Prevention of Immediate Side Effects of BCG Bladder Irrigations. A Double Blind Placebo Controlled Randomized Study
NCT01542567CI-TRIAL-00006965DIC-2011unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abitren | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- diclofenac
- description
- suppositories to prevent BCG side effects
- interventionNames
- Drug: Abitren
- type
- PLACEBO_COMPARATOR
- label
- placebo suppositories
- interventionNames
- Drug: Placebo
Primary outcomes (5)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.