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Efficacy, Safety and Tolerability of Eziclen in Adult Subjects Undergoing Colonoscopy

NCT02321462 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 296

Last updated 2019-03-04

Study results available
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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.

Conditions

  • Bowel Cleansing

Interventions

DRUG

Eziclen

Eziclen solution administered orally as split-dose the day before and on the day of colonoscopy.

DRUG

Fortrans®

Fortrans® solution administered orally as split-dose the day before and on the day of colonoscopy.

Sponsors & Collaborators

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Russia

Study Locations

More Related Trials

Entities

Companies

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 NCT02321462 on ClinicalTrials.gov