Bowel CleansingDUS-BLI800NCT02630680
Eziclen Drug Utilisation in Real Life Setting
An observational study of Bowel Cleansing, run by Ipsen at 16 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Cleansing
- What is being tested?
- Eziclen®/Izinova®
- How many people
- 1,286 participants
- Where
- 16 sitesin 4 countries
- Study dates
- Oct 2015to 25 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Colorectal diseases patients from specialised gastroenterology, hepatogastroenterology departments ("referral centres") and endoscopy departments ("non referral centres").
Who may be able to join
- 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.
Who cannot join
- 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®).
Trial locations and contacts
16 sites in 4 countries.
16 sites in 4 countries
Germany8 sites
MVZ Ortenau Achern, Innere Medizin
Achern, 77855
Gemeinschaftspraxis Dres. Klausmann
Aschaffenburg, 63739
Klinikum Aschaffenburg-Alzenau, Standort Aschaffenburg
Aschaffenburg, 63739
Chefarzt der Medizinischen Klinik III, Westpfalz Klinikum GmbH, Standort I Kaiserslautern
Kaiserslautern, 67655
MVZ Innere Medizin Marburg, Dres. Drude und Partner
Marburg, 35037
Medizinisches Versorgungszentrum
Münster, 48155
Praxisgemeinschaft Innere am Stadtpark
Nuremberg, 90409
Gastro-Praxis Wiesbaden (Gastrodata)
Wiesbaden, 65189
Czechia3 sites
Ustredni vojenska nemocnice
Prague, 169 02
Krajská zdravotní, a.s., nemocnice Teplice
Teplice, 415 01
Ústeckoorlická nemocnice
Ústí nad Orlicí, 562 01
Poland3 sites
Copernicus Medical Entity
Gdansk, 80-462
Instytut Medycyny
Lublin, 20-090
Oncology center - Institutte
Warsaw
Netherlands2 sites
Erasmus MC
Rotterdam, 3015 CE
Elisabeth-Tweesteden Ziekenhuis
Tilburg, 5042 AD
About this study
Official title: 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.
- Conditions
- Bowel Cleansing
- Being tested
- Eziclen®/Izinova®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eziclen®/Izinova®Drug
| Study group | Role | What they receive |
|---|---|---|
| Colorectal diseases patients | Not described Receives: Drug: Eziclen®/Izinova® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: on the day of the colonoscopy
Secondary outcomes (1)
Number of adverse events
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startOct 2015
- Primary completion25 Apr 2017
- Study completion25 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel CleansingStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630680
- Sponsor's protocol ID
- 8-79-58800-001
- Other IDs
- EUPAS9361
- Acronym
- DUS-BLI800
- Status last verified
- Jan 2019
- First submitted
- 11 Dec 2015
- Last updated
- 7 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, European, Observational, Drug Utilisation Study (DUS) of BLI800 (Eziclen®/Izinova®) as a Bowel Cleansing Preparation
- ClinicalTrials.gov ID
- NCT02630680
- Acronym / sponsor ID
- DUS-BLI800 / 8-79-58800-001
- Conditions
- Bowel Cleansing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,286 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- 25 Apr 2017 (actual)
- Study completion
- 25 Apr 2017 (actual)
- First posted
- 15 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal diseases patients | – | Drug: Eziclen®/Izinova® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Colorectal diseases patients from specialised gastroenterology, hepatogastroenterology departments ("referral centres") and endoscopy departments ("non referral centres").
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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®).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eziclen®/Izinova® | Drug | Colorectal diseases patients |
Primary outcome
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).
1 secondary outcome
Number of adverse events
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
16 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bowel Cleansing, run by Ipsen at 16 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany, Czechia, Poland, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of liquid intake (time frame: on the day of the colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2019.