Conditions: Bladder Neoplasms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 355
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Gemcitabine intervention 2: Placebo
Intervention descriptions: intervention 1: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT) intervention 2: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)

Protocol document: