Eziclen Drug Utilisation in Real Life Setting

Bowel Cleansing Clinical Trial

— DUS-BLI800  

Official title:

A Multicentre, European, Observational, Drug Utilisation Study (DUS) of BLI800 (Eziclen®/Izinova®) as a Bowel Cleansing Preparation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02630680
• Other study ID #: 8-79-58800-001
• Secondary ID: EUPAS9361
• Status: Completed
• Start date: October 2015
• Est. completion date: April 25, 2017

Study information

• Verified date: January 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1286
• Est. completion date: April 25, 2017
• Est. primary completion date: April 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patient not eligible for a prescription of BLI800 (Eziclen®/Izinova®) as a cleansing bowel preparation in accordance with the marketing authorisation. Specifically, patients in whom there is a contraindication for use of this product, including patients with congestive heart failure, severe renal insufficiency of active inflammatory bowel disease, are not eligible for inclusion in this study.

• Patient being prescribed a cleansing bowel preparation other than BLI800 (Eziclen®/Izinova®).

Related Conditions & MeSH terms

• Bowel Cleansing

Intervention

Drug:
• Eziclen®/Izinova®

Locations

Country	Name	City	State
Czechia	Ustredni vojenska nemocnice	Praha
Czechia	Krajská zdravotní, a.s., nemocnice Teplice	Teplice
Czechia	Ústeckoorlická nemocnice	Ústí nad Orlicí
Germany	MVZ Ortenau Achern, Innere Medizin	Achern
Germany	Gemeinschaftspraxis Dres. Klausmann	Aschaffenburg
Germany	Klinikum Aschaffenburg-Alzenau, Standort Aschaffenburg	Aschaffenburg
Germany	Chefarzt der Medizinischen Klinik III, Westpfalz Klinikum GmbH, Standort I Kaiserslautern	Kaiserslautern
Germany	MVZ Innere Medizin Marburg, Dres. Drude und Partner	Marburg
Germany	Medizinisches Versorgungszentrum	Münster
Germany	Praxisgemeinschaft Innere am Stadtpark	Nürnberg
Germany	Gastro-Praxis Wiesbaden (Gastrodata)	Wiesbaden
Netherlands	Erasmus MC	Rotterdam
Netherlands	Elisabeth-Tweesteden Ziekenhuis	Tilburg
Poland	Copernicus Medical Entity	Gdansk
Poland	Instytut Medycyny	Lublin
Poland	Oncology center - Institutte	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

Czechia,  Germany,  Netherlands,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of adverse events		Up to 2 years