At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 296 enrolled
Drug / intervention
Eziclen +1 moredrug
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.
Efficacy, Safety and Tolerability of a Split-dose of a New Bowel Cleansing Preparation (Eziclen) in Adult Subjects Undergoing Colonoscopy: A Phase III, Multicentre, Randomised, 2 Parallel Group, Comparative Versus Fortrans®, Non-inferiority, Investigator-blinded Study
In Brief
A Phase 3 clinical trial evaluating Eziclen and Fortrans® for Bowel Cleansing. Completed, enrolled 296 participants across 3 sites.
Detailed Summary
The purpose of this study is to demonstrate that Eziclen is non-inferior to Fortrans® (the reference colonic lavage in Russia) administered in adult subjects scheduled to undergo colonoscopy for a routinely accepted diagnostic indication.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBowel Cleansing
CountriesRussia
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 2014
Enrollment StartMar 2015
Primary CompletionDec 2015
TodayJul 2026
First PostedDec 22, 2014
Enrollment StartMar 1, 2015
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 11.5 years ago
Interventions
Eziclendrug
Eziclen solution administered orally as split-dose the day before and on the day of colonoscopy.
Fortrans®drug
Fortrans® solution administered orally as split-dose the day before and on the day of colonoscopy.