Addition of hyaluronate to mitomycin vs mitomycin in low risk bladder cancer

Phase 1

• Conditions: ow risk not muscle-infiltrating bladder neoplasia; MedDRA version: 20.0Level: PTClassification code 10005005Term: Bladder cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-003813-92-IT
• Lead Sponsor: IBSA FARMACEUTICI ITALIA SR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-22
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Both gender with 18-80 years of age
Physiological/Surgical Menopause
Histological diagnosis of transitional vesical neoplasia
Patients with vesical neoplasia at low risk according to EORTC
Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

Hypersensitivity either to Ialurill Prefill or to one of its component
Hypersensitivity and controindications to Mitomycin C
Ongoing macroematuria
Suspected bladder drill
Patients with vesical neoplasia at high risk according to EORTC
Capacity of bladder < 300 cc

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified