Trials / Completed
CompletedNCT03008460
Efficacy, Safety and Tolerability of Eziclen®/Izinova® Versus Klean-prep® on Bowel Cleansing in Adolescents Undergoing Colonoscopy
Efficacy, Safety and Tolerability of a Bowel Cleansing Preparation (Eziclen/Izinova®) in Paediatric Subjects Undergoing Colonoscopy: a Phase III, Multicentre, Randomised, Comparative Study Versus Klean-Prep® (PEG-Electrolytes), Administered on the Day Before Colonoscopy, Investigator-blinded, Non-inferiority in Adolescents of 12 to 17 Years of Age (Inclusive) >40 kg
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 250 (actual)
- Sponsor
- Ipsen · Industry
- Sex
- All
- Age
- 12 Years – 17 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Eziclen®/Izinova® | Oral solution taken the evening before the colonoscopy |
| DRUG | Klean-Prep® | Oral solution taken the evening before the colonoscopy |
Timeline
- Start date
- 2017-10-15
- Primary completion
- 2020-02-24
- Completion
- 2020-06-29
- First posted
- 2017-01-02
- Last updated
- 2021-03-02
- Results posted
- 2021-03-02
Locations
24 sites across 6 countries: Czechia, France, Germany, Italy, Netherlands, Poland
Source: ClinicalTrials.gov record NCT03008460. Inclusion in this directory is not an endorsement.