NCT00191477

Instillation of Gemcitabine in Patients With Superficial Bladder Cancer

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Multicenter Study of Immediate Postoperative Instillation of Gemcitabine in Patients With Superficial Transitional Cell Carcinoma of the Bladder

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 355 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2004-01-01
• Primary completion: 2008-03-01
• Completion: 2008-06-01
• First posted: 2005-09-19
• Last updated: 2009-10-28
• Results posted: 2009-10-28

Locations

1 site across 1 country: Germany