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Bladder Cancer | Efficacy of Diclofenac BCG Irrigations

Bladder Cancer research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Bladder Cancer

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:AbitrenSUPPOSITORIES 50 Mg 2 SUPPOSITORIES A WEEK

Drug:PlaceboPlacebo suppositories

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

diclofenacsuppositories to prevent BCG side effects

placebo suppositories

Study Status

Unknown status

Start Date: May 2012

Completed Date:

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Change in weekly COOP Questionnaire 1

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Carmel Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01542567

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