CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
Pudexacianinium chloridedrug
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/NCT04238481
NCT04238481Phase 2Completed
CompareCT.gov

A Phase 2 Randomized Open-label, Dose-ranging Study for Ureter Visualization Using ASP5354 in Subjects Undergoing Laparoscopic/Minimally Invasive Colorectal Surgery

Astellas Pharma Inc·interventional·Posted Jan 23, 2020·Updated Oct 24, 2024

In Brief

A Phase 2 clinical trial evaluating Pudexacianinium chloride for Laparoscopic/Minimally Invasive Colorectal Surgery. Completed, enrolled 13 participants across 2 sites.

Detailed Summary

The primary purpose of this study was to determine the optimal dose of ASP5354 for ureter visualization in participants undergoing laparoscopic/minimally invasive colorectal surgery This study also investigated the safety, tolerability and the pharmacokinetics of ASP5354 in participants undergoing laparoscopic/minimally invasive colorectal surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLaparoscopic/Minimally Invasive Colorectal Surgery
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJan 23, 2020
Enrollment StartOct 6, 2020
Primary CompletionNov 18, 2021
Study CompletionNov 29, 2021
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 6.4 years ago

Interventions

Pudexacianinium chloridedrug

Intravenous