We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Eziclen Drug Utilisation in Real Life Setting (DUS-BLI800)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02630680
Recruitment Status : Completed
First Posted : December 15, 2015
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Bowel Cleansing Drug: Eziclen®/Izinova®

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 1286 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicentre, European, Observational, Drug Utilisation Study (DUS) of BLI800 (Eziclen®/Izinova®) as a Bowel Cleansing Preparation
Study Start Date : October 2015
Actual Primary Completion Date : April 25, 2017
Actual Study Completion Date : April 25, 2017
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Colorectal diseases patients Drug: Eziclen®/Izinova®


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Volume of liquid intake [ Time Frame: 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 :
  1. Number of adverse events [ Time Frame: Up to 2 years ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Colorectal diseases patients from specialised gastroenterology, hepatogastroenterology departments ("referral centres") and endoscopy departments ("non referral centres").
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®).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02630680


Locations
Layout table for location information
Czechia
Ustredni vojenska nemocnice
Praha, Czechia, 169 02
Krajská zdravotní, a.s., nemocnice Teplice
Teplice, Czechia, 415 01
Ústeckoorlická nemocnice
Ústí nad Orlicí, Czechia, 562 01
Germany
MVZ Ortenau Achern, Innere Medizin
Achern, Germany, 77855
Gemeinschaftspraxis Dres. Klausmann
Aschaffenburg, Germany, 63739
Klinikum Aschaffenburg-Alzenau, Standort Aschaffenburg
Aschaffenburg, Germany, 63739
Chefarzt der Medizinischen Klinik III, Westpfalz Klinikum GmbH, Standort I Kaiserslautern
Kaiserslautern, Germany, 67655
MVZ Innere Medizin Marburg, Dres. Drude und Partner
Marburg, Germany, 35037
Medizinisches Versorgungszentrum
Münster, Germany, 48155
Praxisgemeinschaft Innere am Stadtpark
Nürnberg, Germany, 90409
Gastro-Praxis Wiesbaden (Gastrodata)
Wiesbaden, Germany, 65189
Netherlands
Erasmus MC
Rotterdam, Netherlands, 3015 CE
Elisabeth-Tweesteden Ziekenhuis
Tilburg, Netherlands, 5042 AD
Poland
Copernicus Medical Entity
Gdańsk, Poland, 80-462
Instytut Medycyny
Lublin, Poland, 20-090
Oncology center - Institutte
Warsaw, Poland
Sponsors and Collaborators
Ipsen
Investigators
Layout table for investigator information
Study Director: Ipsen Medical Director Ipsen
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02630680    
Other Study ID Numbers: 8-79-58800-001
EUPAS9361 ( Registry Identifier: EU PAS Register )
First Posted: December 15, 2015    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019