Eziclen Drug Utilisation in Real Life Setting

Completed

• Conditions: Bowel Cleansing
• Interventions: Drug: Eziclen®/Izinova®

• Registration Number: NCT02630680
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-12-11
• Study First Submitted QC: 2015-12-11
• Study First Posted: 2015-12-15
• Primary Completion: 2017-04-25
• Study Completion: 2017-04-25
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-04
• Last Update Posted: 2019-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1286

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®).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Colorectal diseases patients	Eziclen®/Izinova®	-

Primary Outcome Measures

Name	Time	Method
Volume of liquid intake	on the day of the colonoscopy	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).

Secondary Outcome Measures

Name	Time	Method
Number of adverse events	Up to 2 years

Trial Locations

Locations (16)

Ustredni vojenska nemocnice; 🇨🇿 Praha, Czechia

Gemeinschaftspraxis Dres. Klausmann; 🇩🇪 Aschaffenburg, Germany

Krajská zdravotní, a.s., nemocnice Teplice; 🇨🇿 Teplice, Czechia

Ústeckoorlická nemocnice; 🇨🇿 Ústí nad Orlicí, Czechia

MVZ Ortenau Achern, Innere Medizin; 🇩🇪 Achern, 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, Germany

Erasmus MC; 🇳🇱 Rotterdam, Netherlands

Elisabeth-Tweesteden Ziekenhuis; 🇳🇱 Tilburg, Netherlands

Copernicus Medical Entity; 🇵🇱 Gdańsk, Poland

Instytut Medycyny; 🇵🇱 Lublin, Poland

Oncology center - Institutte; 🇵🇱 Warsaw, Poland