Impact of the mitomicin-C (MMC) preoperative administration in patients with primary urothelial non-muscle invasive bladder cancer (TVNMI) using electromotive instillation (EMDA). Prospective randomised study.
Conditions
Interventions
Trade Name: MITOMICINA c
Pharmaceutical Form:
INN or Proposed INN: MITOMYCIN
CAS Number: 50-07-7
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 10-40
Trade Name:
Sponsors
PRESURGY S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: INCLUSION CRITERIA ( Please refer to Spanish version below) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 105 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 123
Exclusion criteria
Exclusion criteria: EXCLUSION CRITERIA ( Please refer to Spanish version below)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Refer to Spanish version below.;Secondary Objective: Refer to Spanish version below.;Primary end point(s): END POINTS ( Please refer to Spanish version below);Timepoint(s) of evaluation of this end point: 60 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary points ( Please refer to Spanish version below);Timepoint(s) of evaluation of this end point: 60 months | — |
Countries
Spain
Contacts
Public ContactMario Serrano
PRESURGY S.L.
Outcome results
None listed