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Instillation of Gemcitabine in Patients With Superficial Bladder Cancer

NCT00191477 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 355

Last updated 2009-10-28

Study results available
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Summary

A randomized, double-blind, placebo-controlled Phase 3 multicenter study to assess the efficacy and safety of intravesical instillation of gemcitabine versus placebo immediately after transurethral resection of the bladder tumor.

Conditions

  • Bladder Neoplasms

Interventions

DRUG

Gemcitabine

2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)

DRUG

Placebo

intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2008-03-31
Completion
2008-06-30

Countries

  • Germany

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00191477 on ClinicalTrials.gov