Bowel CleanlinessCLEARNCT01220453
Compliance and Efficacy in the Use of PICOPREP®
An observational study of Bowel Cleanliness, run by Ferring Pharmaceuticals at 121 sites in Germany.
Trial summary
The present trial is aimed to document efficacy (bowel cleanliness), acceptance and tolerability as well as patient comfort in the use of the new bowel cleansing product PICOPREP® in every day practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Cleanliness
- How many people
- 2,165 participants
- Where
- 121 sitesGermany
- Study dates
- Oct 2010to Jul 2011
- 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: Community sample
Who may be able to join
- Patients receiving PICOPREP® for bowel evacuation prior to endoscopy or surgery
- Patients who have been informed about the NIS and have given their written consent for participation
Who cannot join
- Patients in which prescription of PICOPREP® is contraindicated
Trial locations and contacts
121 sites in 1 country.
121 sites in 1 country
Germany121 sites
Investigational Site
Altdorf
Investigational Site
Altenholz
Investigational Site
Augsburg
Investigational Site
Bad Lausick
Investigational Site
Bad Schwalbach
Investigational Site
Bayreuth
Investigational Site
Beckum
Investigational Site
Berlin
Investigational Site
Bielefeld
Investigational Site
Bietigheim
Private Practice
Bietigheim-Bissingen
Investigational Site
Bitterfeld-Wolfen
Investigational Site
Bonn
Investigational Site
Brandenburg
Investigational Site
Braunschweig
Investigational Site
Brinkum
Investigational Site
Buchholz
Investigational Site
Butzbach
Investigational Site
Castrop-Rauxel
Investigational Site
Cologne
Investigational Site
Cottbus
Investigational Site
Dachau
Investigational Site
Detmold
Investigational Site
Dingolfing
Investigational Site
Dippoldswalde
Investigational Site
Dortmund
Investigational Site
Dresden
Investigational Site
Düsseldorf
Investigational Site
Eberswalde
Investigational Site
Elsterwerda
Investigational Site
Erftstadt
Investigational Site
Erfurt
Investigational Site
Eschweiler
Investigational Site
Essen
Investigational Site
Forchheim
Investigational Site
Frankfurt
Investigational Site
Freiburg im Breisgau
Investigational Site
Friedrichshafen
Investigational Site
Gelsenkirchen
Investigational Site
Germering
Investigational Site
Giessen
Investigational Site
Giffhorn-Winkel
Investigational Site
Gilching
Investigational Site
Göppingen
Investigational Site
Goslar
Investigational Site
Grevenbroich
Investigational Site
Hagen
Investigational Site
Halle
Investigational Site
Haltern am See
Investigational Site
Hamburg
Investigational Site
Hamelin
Investigational Site
Hanover
Investigational Site
Haßloch
Investigational Site
Hebel
Investigational site
Hechingen
Investigational Site
Heinsberg
Investigational Site
Herne
Investigational Site
Herten
Investigational Site
Herzogenrath
Investigational Site
Hildesheim
Investigational Site
Hürth
Investigational Site
Itzehoe
Investigational Site
Jena
Investigational Site
Jerichow
Investigational Site
Juehlich
Investigational Site
Karlsruhe
Investigational Site
Karlstadt am Main
Investigational Site
Kassel
Investigational Site
Kiel
Investigational Site
Kitzingen
Investigational Site
Koblenz
Investigational Site
Königstein
Investigational Site
Königswusterhausen
Investigational Site
Landshut
Investigational Site
Leipzig
Investigational Site
Leverkusen
Investigational Site
Lübeck
Investigational Site
Ludwigshafen
Investigational Site
Magdeburg
Investigational Site
Mainz
Investigational Site
Mannheim
Investigational Site
Mönchengladbach
Investigational Site
Muenzenberg-Gambach
Investigational Site
München
Investigational Site
Münster
Investigational Site
Neubrandenburg
Investigational Site
Neumarkt
Investigational Site
Neumünster
Investigational Site
Neustadt
Investigational Site
Nienburg
Investigational Site
Nuremberg
Investigational Site
Oldenburg
Investigational Site
Paderborn
Investigational Site
Papenburg
Investigational Site
Plauen
Investigational Site
Polheim
Investigational Site
Potsdam
Investigational Site
Rheda
Investigational Site
Rinteln
Investigational Site
Rosenheim
Investigational Site
Rostock
Investigational Site
Rottach-Weissach
Investigational Site
Rottenburg
Investigational Site
Schwäbisch Hall
Investigational Site
Schweinfurt
Investigational Site
Siegen
Investigational site
Singen
Investigational Site
Stade
Investigational Site
Steinfurt
Investigational Site
Stuttgart
Investigational Site
Traunstein
Investigational Site
Uelzen
Investigational Site
Varel
Investigational Site
Waltrop
Investigational Site
Weißenburg
Investigational Site
Wertheim am Main
Investigational Site
Wesseling
Investigational Site
Wetzlar
Investigational Site
Wilhelmshaven
Investigational Site
Wittenberg
Investigational Site
Wriezen
About this study
Official title: Compliance and Efficacy in the Use of PICOPREP® for Bowel Cleansing
The present trial is aimed to document efficacy (bowel cleanliness), acceptance and tolerability as well as patient comfort in the use of the new bowel cleansing product PICOPREP® in every day practice. In particular, it should be evaluated, whether bowel cleanliness, acceptance, tolerability and patient comfort are affected by specific practice procedures, changes in dose etc.
- Conditions
- Bowel Cleanliness
What is being measured
The primary outcome is the main question the study is designed to answer.
Documentation of the use of PICOPREP® in every day practice
Will evaluate efficacy (bowel cleanliness), compliance, acceptance, tolerability and patient comfort
Measured: 2 days
Secondary outcomes (4)
Documentation of patient satisfaction after bowel cleansing
Measured: 2 days
Documentation of examiner satisfaction after colonoscopy
Measured: 2 days
Identification of patient groups in which bowel cleansing is more difficult due to concomitant diseases or other conditions (risk groups)
Measured: 2 days
Tolerability: frequency and severity of adverse events
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionMay 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel CleanlinessStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 2,165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ferring Arzneimittel GmbH
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220453
- Sponsor's protocol ID
- FE999169 CS01
- Acronym
- CLEAR
- Status last verified
- Oct 2012
- First submitted
- 5 Oct 2010
- Last updated
- 8 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance and Efficacy in the Use of PICOPREP® for Bowel Cleansing
- ClinicalTrials.gov ID
- NCT01220453
- Acronym / sponsor ID
- CLEAR / FE999169 CS01
- Conditions
- Bowel Cleanliness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,165 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Ferring Arzneimittel GmbH
- Study start
- Oct 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 14 Oct 2010 (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 present trial is aimed to document efficacy (bowel cleanliness), acceptance and tolerability as well as patient comfort in the use of the new bowel cleansing product PICOPREP® in every day practice. In particular, it should be evaluated, whether bowel cleanliness, acceptance, tolerability and patient comfort are affected by specific practice procedures, changes in dose etc.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (2 listed)
- Patients receiving PICOPREP® for bowel evacuation prior to endoscopy or surgery
- Patients who have been informed about the NIS and have given their written consent for participation
Key exclusion criteria (1 listed)
- Patients in which prescription of PICOPREP® is contraindicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Documentation of the use of PICOPREP® in every day practice
Time frame: 2 days
Will evaluate efficacy (bowel cleanliness), compliance, acceptance, tolerability and patient comfort
4 secondary outcomes
Documentation of patient satisfaction after bowel cleansing
Time frame: 2 days
Documentation of examiner satisfaction after colonoscopy
Time frame: 2 days
Identification of patient groups in which bowel cleansing is more difficult due to concomitant diseases or other conditions (risk groups)
Time frame: 2 days
Tolerability: frequency and severity of adverse events
Time frame: 2 days
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 8 Oct 2012.
Related trials for Bowel Cleanliness
Recruiting
Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
The Effect of Audio-visual Aids on Bowel Cleanliness, Audiovisual Aids
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.
Clinical Development Support study director
Ferring Pharmaceuticals
121 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bowel Cleanliness, run by Ferring Pharmaceuticals at 121 sites in Germany.
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 1 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 8 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 121 sites in Germany. 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?
Documentation of the use of PICOPREP® in every day practice (time frame: 2 days). 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 8 Oct 2012; AzTrials last refreshed its copy on 7 Nov 2026.