CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 100 enrolled
Drug / intervention
Radiotherapy+IAluril®+Ialuril Soft Gels® +1 morecombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03493997
NCT03493997Phase 2Completed

An Investigative, Randomized, Open, Pilot Study to Assess the Tolerability, Safety and Efficacy of HAcid/CS Intravesical Instillations Plus an Oral Combination of Curcumin,Quercetin, HA and CS in Prevention of Radiation Induced Cystitis

Study Group for Urogenital Diseases, Italy·interventional·Posted Apr 11, 2018·Updated Jul 23, 2020

In Brief

A Phase 2 clinical trial evaluating Radiotherapy+IAluril®+Ialuril Soft Gels® and Radiotherapy only for Prostate Cancer. Completed, enrolled 100 participants across 7 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesItaly, Slovakia, Spain, Turkey (Türkiye)
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 11, 2018
Enrollment StartApr 4, 2017
Primary CompletionOct 31, 2018
Study CompletionMay 31, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 8.2 years ago

Interventions

Radiotherapy+IAluril®+Ialuril Soft Gels®combination

Radiotherapy+IAluril®+Ialuril Soft Gels®

Radiotherapy onlyradiation

Radiotherapy only