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Eziclen Drug Utilisation in Real Life Setting

NCT ID: NCT02630680

Last Updated: 2019-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1286 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-04-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Bowel Cleansing

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Colorectal diseases patients

Eziclen®/Izinova®

Intervention Type DRUG

Interventions

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Eziclen®/Izinova®

Intervention Type DRUG

Eligibility Criteria

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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®).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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Ustredni vojenska nemocnice

Prague, , Czechia

Site Status

Krajská zdravotní, a.s., nemocnice Teplice

Teplice, , Czechia

Site Status

Ústeckoorlická nemocnice

Ústí nad Orlicí, , Czechia

Site Status

MVZ Ortenau Achern, Innere Medizin

Achern, , Germany

Site Status

Gemeinschaftspraxis Dres. Klausmann

Aschaffenburg, , Germany

Site Status

Klinikum Aschaffenburg-Alzenau, Standort Aschaffenburg

Aschaffenburg, , Germany

Site Status

Chefarzt der Medizinischen Klinik III, Westpfalz Klinikum GmbH, Standort I Kaiserslautern

Kaiserslautern, , Germany

Site Status

MVZ Innere Medizin Marburg, Dres. Drude und Partner

Marburg, , Germany

Site Status

Medizinisches Versorgungszentrum

Münster, , Germany

Site Status

Praxisgemeinschaft Innere am Stadtpark

Nuremberg, , Germany

Site Status

Gastro-Praxis Wiesbaden (Gastrodata)

Wiesbaden, , Germany

Site Status

Erasmus MC

Rotterdam, , Netherlands

Site Status

Elisabeth-Tweesteden Ziekenhuis

Tilburg, , Netherlands

Site Status

Copernicus Medical Entity

Gdansk, , Poland

Site Status

Instytut Medycyny

Lublin, , Poland

Site Status

Oncology center - Institutte

Warsaw, , Poland

Site Status

Countries

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Czechia Germany Netherlands Poland

Other Identifiers

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EUPAS9361

Identifier Type: REGISTRY

Identifier Source: secondary_id

8-79-58800-001

Identifier Type: -

Identifier Source: org_study_id

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