Clinical trial NCT02630680: Eziclen Drug Utilisation in Real Life Setting
Official title: A Multicentre, European, Observational, Drug Utilisation Study (DUS) of BLI800 (Eziclen®/Izinova®) as a Bowel Cleansing Preparation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bowel Cleansing
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2015-12-15
Enrollment: 1286
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Colorectal diseases patients from specialised gastroenterology, hepatogastroenterology departments ("referral centres") and endoscopy departments ("non referral centres").

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.


Eligibility criteria: 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®).

Primary outcomes:
measure: Volume of liquid intake
timeFrame: on the day of the colonoscopy
Secondary outcomes:
measure: Number of adverse events
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Ustredni vojenska nemocnice
city: Teplice
country: Czechia
facility: Krajská zdravotní, a.s., nemocnice Teplice
city: Ústí nad Orlicí
country: Czechia
facility: Ústeckoorlická nemocnice
city: Achern
country: Germany
facility: MVZ Ortenau Achern, Innere Medizin
city: Aschaffenburg
country: Germany
facility: Gemeinschaftspraxis Dres. Klausmann
city: Aschaffenburg
country: Germany
facility: Klinikum Aschaffenburg-Alzenau, Standort Aschaffenburg
city: Kaiserslautern
country: Germany
facility: Chefarzt der Medizinischen Klinik III, Westpfalz Klinikum GmbH, Standort I Kaiserslautern
city: Marburg
country: Germany
facility: MVZ Innere Medizin Marburg, Dres. Drude und Partner
city: Münster
country: Germany
facility: Medizinisches Versorgungszentrum
city: Nürnberg
country: Germany
facility: Praxisgemeinschaft Innere am Stadtpark
city: Wiesbaden
country: Germany
facility: Gastro-Praxis Wiesbaden (Gastrodata)
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Tilburg
country: Netherlands
facility: Elisabeth-Tweesteden Ziekenhuis
city: Gdańsk
country: Poland
facility: Copernicus Medical Entity
city: Lublin
country: Poland
facility: Instytut Medycyny
city: Warsaw
country: Poland
facility: Oncology center - Institutte
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: