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

January 4, 2019 updated by: Ipsen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1286

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Praha, Czechia, 169 02
        • Ustredni vojenska nemocnice
      • Teplice, Czechia, 415 01
        • Krajská zdravotní, a.s., nemocnice Teplice
      • Ústí nad Orlicí, Czechia, 562 01
        • Ústeckoorlická nemocnice
  • Germany
      • Achern, Germany, 77855
        • MVZ Ortenau Achern, Innere Medizin
      • Aschaffenburg, Germany, 63739
        • Gemeinschaftspraxis Dres. Klausmann
      • Aschaffenburg, Germany, 63739
        • Klinikum Aschaffenburg-Alzenau, Standort Aschaffenburg
      • Kaiserslautern, Germany, 67655
        • Chefarzt der Medizinischen Klinik III, Westpfalz Klinikum GmbH, Standort I Kaiserslautern
      • Marburg, Germany, 35037
        • MVZ Innere Medizin Marburg, Dres. Drude und Partner
      • Münster, Germany, 48155
        • Medizinisches Versorgungszentrum
      • Nürnberg, Germany, 90409
        • Praxisgemeinschaft Innere am Stadtpark
      • Wiesbaden, Germany, 65189
        • Gastro-Praxis Wiesbaden (Gastrodata)
  • Netherlands
      • Rotterdam, Netherlands, 3015 CE
        • Erasmus MC
      • Tilburg, Netherlands, 5042 AD
        • Elisabeth-TweeSteden Ziekenhuis
  • Poland
      • Gdańsk, Poland, 80-462
        • Copernicus Medical Entity
      • Lublin, Poland, 20-090
        • Instytut Medycyny
      • Warsaw, Poland
        • Oncology center - Institutte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Colorectal diseases patients from specialised gastroenterology, hepatogastroenterology departments ("referral centres") and endoscopy departments ("non referral centres").

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
on the day of the colonoscopy

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of adverse events
Time Frame: Up to 2 years
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

April 25, 2017

Study Completion (Actual)

April 25, 2017

Study Registration Dates

First Submitted

December 11, 2015

First Submitted That Met QC Criteria

December 11, 2015

First Posted (Estimate)

December 15, 2015

Study Record Updates

Last Update Posted (Actual)

January 7, 2019

Last Update Submitted That Met QC Criteria

January 4, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 8-79-58800-001
  • EUPAS9361 (Registry Identifier: EU PAS Register)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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