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Efficacy, Safety and Tolerability of Eziclen®/Izinova® Versus Klean-prep® on Bowel Cleansing in Adolescents Undergoing Colonoscopy

NCT03008460 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2021-03-02

Study results available
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Summary

The purpose of the protocol is to demonstrate that Eziclen®/Izinova®, an osmotic sulphate-based laxative preparation given on the day before colonoscopy has non-inferior efficacy to Klean-Prep® (polyethylene glycol (PEG)-electrolytes) on colon cleansing in adolescents aged 12 to 17 years (inclusive) with a body weight \>40 kg, scheduled to undergo a colonoscopy for a routinely accepted diagnostic indication.

Conditions

  • Digestive System Disease

Interventions

DRUG

Eziclen®/Izinova®

Oral solution taken the evening before the colonoscopy

DRUG

Klean-Prep®

Oral solution taken the evening before the colonoscopy

Sponsors & Collaborators

Principal Investigators

  • Ipsen Medical Director · Ipsen Consumer Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-15
Primary Completion
2020-02-24
Completion
2020-06-29

Countries

  • Czechia
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland

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 NCT03008460 on ClinicalTrials.gov