Trials / Completed
CompletedNCT02321462
Efficacy, Safety and Tolerability of Eziclen in Adult Subjects Undergoing Colonoscopy
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 296 (actual)
- Sponsor
- Ipsen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2015-03-01
- Primary completion
- 2015-12-01
- Completion
- 2015-12-01
- First posted
- 2014-12-22
- Last updated
- 2019-03-04
- Results posted
- 2019-02-27
Locations
3 sites across 1 country: Russia
Source: ClinicalTrials.gov record NCT02321462. Inclusion in this directory is not an endorsement.