NCT01542567

Brief 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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Last Updated

May 22, 2012

Status Verified

May 1, 2012

Enrollment Period

2 years

First QC Date

February 14, 2012

Last Update Submit

May 20, 2012

Conditions

Bladder Cancer

Keywords

DiclofenacBCGBLADDER IRRIGATIONS

Outcome Measures

Primary Outcomes (5)

  • Change in weekly COOP Questionnaire 1

    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.

    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

  • Change in weekly COOP Questionnaire 2

    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.

    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

  • Change in weekly COOP Questionnaire 3

    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.

    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

  • Change in weekly Bladder symptoms Questionnaire

    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.

    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

  • Change in weekly time schedule questionnaire

    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.

    every week for 6 weeks

Study Arms (2)

diclofenac

ACTIVE COMPARATOR

suppositories to prevent BCG side effects

Drug: Abitren

placebo suppositories

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AbitrenDRUG

SUPPOSITORIES 50 Mg 2 SUPPOSITORIES A WEEK

diclofenac
PlaceboDRUG

Placebo suppositories

placebo suppositories

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Avi Stein

Study Record Dates

First Submitted

February 14, 2012

First Posted

March 2, 2012

Study Start

May 1, 2012

Primary Completion

May 1, 2014

Last Updated

May 22, 2012

Record last verified: 2012-05