Eziclen Drug Utilisation in Real Life Setting | NCT02630680

Studies
Eziclen Drug Utilisation in Real Life Setting

NCT02630680

Sponsor

Ipsen

Status

Completed

Last Update Posted

Jan 7, 2019Actual

Enrollment

1,286Actual

Phase

Not provided

Conditions

Bowel Cleansing

Interventions

Eziclen®/Izinova®

Countries

Czechia
Germany
Netherlands
Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EUPAS9361	Registry Identifier	EU PAS Register

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Apr 25, 2017Actual

Completion Date

Apr 25, 2017Actual

First Submitted Date

Dec 11, 2015

First Submission Date that Met QC Criteria

Dec 11, 2015

First Posted Date

Dec 15, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2019

Last Update Posted Date

Jan 7, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,286Actual

Label	Type	Description	Intervention Names
Colorectal diseases patients			Drug: Eziclen®/Izinova®

Name	Type	Description	Arm Group Labels	Other Names
Eziclen®/Izinova®	Drug		Colorectal diseases patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Volume of liquid intake	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 Outcomes

Measure	Description	Time Frame
Number of adverse events		Up to 2 years

Other Outcomes

Not provided

Eligibility Module

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®).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ipsen Medical Director	Ipsen	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ustredni vojenska nemocnice		Prague		169 02	Czechia
Krajská zdravotní, a.s., nemocnice Teplice