Eziclen Drug Utilisation in Real Life Setting
DUS-BLI800
A Multicentre, European, Observational, Drug Utilisation Study (DUS) of BLI800 (Eziclen®/Izinova®) as a Bowel Cleansing Preparation
2 other identifiers
observational
1,286
4 countries
16
Brief Summary
The purpose of the study is to assess Eziclen/Izinova drug utilisation in the real life setting in a representative sample of the European target population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2015
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 11, 2015
CompletedFirst Posted
Study publicly available on registry
December 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2017
CompletedJanuary 7, 2019
January 1, 2019
1.6 years
December 11, 2015
January 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Volume of liquid intake
Assessment of non-compliance in terms of insufficient liquid intake. The volume of water and clear liquids taken will be derived from the remaining volumes as recorded on the patient's leaflet and reported by the Investigator. Compliance to the hydration guidelines expressed in terms of a ratio (actual volume taken versus theoretical volume).
on the day of the colonoscopy
Secondary Outcomes (1)
Number of adverse events
Up to 2 years
Study Arms (1)
Colorectal diseases patients
Interventions
Eligibility Criteria
Colorectal diseases patients from specialised gastroenterology, hepatogastroenterology departments ("referral centres") and endoscopy departments ("non referral centres").
You may qualify if:
- Patient eligible for a prescription of BLI800 (Eziclen®/Izinova®) as a cleansing bowel preparation in accordance with the marketing authorisation.
- Patient having provided written informed consent.
You may not qualify if:
- Patient being prescribed a cleansing bowel preparation other than BLI800 (Eziclen®/Izinova®).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (16)
Ustredni vojenska nemocnice
Prague, 169 02, Czechia
Krajská zdravotní, a.s., nemocnice Teplice
Teplice, 415 01, Czechia
Ústeckoorlická nemocnice
Ústí nad Orlicí, 562 01, Czechia
MVZ Ortenau Achern, Innere Medizin
Achern, 77855, Germany
Gemeinschaftspraxis Dres. Klausmann
Aschaffenburg, 63739, Germany
Klinikum Aschaffenburg-Alzenau, Standort Aschaffenburg
Aschaffenburg, 63739, Germany
Chefarzt der Medizinischen Klinik III, Westpfalz Klinikum GmbH, Standort I Kaiserslautern
Kaiserslautern, 67655, Germany
MVZ Innere Medizin Marburg, Dres. Drude und Partner
Marburg, 35037, Germany
Medizinisches Versorgungszentrum
Münster, 48155, Germany
Praxisgemeinschaft Innere am Stadtpark
Nuremberg, 90409, Germany
Gastro-Praxis Wiesbaden (Gastrodata)
Wiesbaden, 65189, Germany
Erasmus MC
Rotterdam, 3015 CE, Netherlands
Elisabeth-Tweesteden Ziekenhuis
Tilburg, 5042 AD, Netherlands
Copernicus Medical Entity
Gdansk, 80-462, Poland
Instytut Medycyny
Lublin, 20-090, Poland
Oncology center - Institutte
Warsaw, Poland
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2015
First Posted
December 15, 2015
Study Start
October 1, 2015
Primary Completion
April 25, 2017
Study Completion
April 25, 2017
Last Updated
January 7, 2019
Record last verified: 2019-01