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ACTIVE NOT RECRUITING
NCT02106572
PHASE3

Therapeutic Instillation of Mistletoe

Sponsor: Abnoba Gmbh

View on ClinicalTrials.gov

Summary

The aim of this phase III study is to assess the efficacy of abnobaVISCUM® 900 compared with Mitomycin C (MMC) monotherapy in patients with superficial bladder carcinoma by evaluation of the time to tumor recurrence. Secondary objective is to evaluate the safety of abnobaVISCUM® 900, in particular, to compare the toxicity of the two treatments. Another secondary objective is the treatment efficacy as measured by calculated prognosis for recurrence and progression after 1 year, the tumor grading in case of a recurrence and by measurement of Quality of Life.

Official title: Intravesical Mistletoe Extract in Superficial Bladder Cancer: A Phase III Efficacy Study

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

548

Start Date

2015-04

Completion Date

2028-12

Last Updated

2025-07-23

Healthy Volunteers

No

Interventions

DRUG

abnobaVISCUM 900

intravesical instillation of abnobaVISCUM 900 13 times during treatment period

DRUG

Mitomycin C

intravesical instillation of Mitomycin C 10 times during treatment period

Locations (5)

Theodor Bilharz Research Institute

Giza, Egypt

Clinic of Urology of the University Hospital of Essen

Essen, Germany

Urologische Gemeinschaftspraxis

Heinsberg, Germany

Urologische Praxis

Herzberg, Germany

Urologische Facharztpraxis

Würselen, Germany