MedTrace Logo

Multicentre International STudy for the Prevention With Ialuril® of Radio-induced Cystitis (MISTIC)

NCT03493997 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-07-23

No results posted yet for this study

Summary

The study is randomized and it will be conducted in the field of routine clinical practice. A total of 100 consecutive patients planned to receive radiotherapy for prostate cancer will be enrolled.

The patients will enter the study as controls (50 patients that won't receive any experimental IMP) or as treated-group (50 patients that will be also treated with the experimental IMPs, Ialuril® and Ialuril® Soft Gels) according to a predefined, centre-specific randomization.

Conditions

Interventions

COMBINATION_PRODUCT

Radiotherapy+IAluril®+Ialuril Soft Gels®

Radiotherapy+IAluril®+Ialuril Soft Gels®

RADIATION

Radiotherapy only

Radiotherapy only

Sponsors & Collaborators

  • Study Group for Urogenital Diseases, Italy

    lead OTHER

Principal Investigators

  • Massimo LAzzeri, MD · Gruppo di Studio per le Malattie Urogenitali

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-04
Primary Completion
2018-10-31
Completion
2020-05-31

Countries

  • Italy
  • Slovakia
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03493997 on ClinicalTrials.gov