Trials / Terminated
TerminatedNCT01475266
Single Immediate Instillation of EO9 After TURBT in Patients With Non-muscle-invasive Bladder Cancer (NMIBC)
Randomized, Placebo-controlled, Double-blinded Study of Single Immediate Instillation of EO9 After TURBT in Patients With NMIBC
- Status
- Terminated
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- Nippon Kayaku Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety in patients with non-muscle invasive bladder cancer histologically diagnosed to be stage Ta and G1 or G2 and who were randomized into either an EO9 or placebo group after TURBT.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | EO9 (Apaziquone) | 4 mg/40 mL, Intravesical instillation, Single dose within 6 hours after TURBT |
| DRUG | Placebo | 40 mL, Intravesical instillation, Single dose within 6 hours after TURBT |
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2013-04-01
- Completion
- 2013-04-01
- First posted
- 2011-11-21
- Last updated
- 2017-03-29
Locations
20 sites across 2 countries: Japan, South Korea
Source: ClinicalTrials.gov record NCT01475266. Inclusion in this directory is not an endorsement.