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OpenTrials
Completed

NCT Number: NCT02630680

Eziclen Drug Utilisation in Real Life Setting

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.

Completed

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Key information

Conditions

Bowel Cleansing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ustredni vojenska nemocnice, Prague, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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®).

Treatment and study plan

Eziclen®/Izinova®

Drug

Primary outcomes

  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 outcomes

  1. Number of adverse events

    Time frame: Up to 2 years

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

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

Acronym: DUS-BLI800

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 15, 2015
Registry last updated
Jan 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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