Compliance and Efficacy in the Use of PICOPREP®
CLEAR
1 other identifier
observational
2,165
1 country
121
Brief 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. In particular, it should be evaluated, whether bowel cleanliness, acceptance, tolerability and patient comfort are affected by specific practice procedures, changes in dose etc.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2010
Shorter than P25 for all trials
121 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 5, 2010
CompletedFirst Posted
Study publicly available on registry
October 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedOctober 8, 2012
October 1, 2012
7 months
October 5, 2010
October 5, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Documentation of the use of PICOPREP® in every day practice
Will evaluate efficacy (bowel cleanliness), compliance, acceptance, tolerability and patient comfort
2 days
Secondary Outcomes (4)
Documentation of patient satisfaction after bowel cleansing
2 days
Documentation of examiner satisfaction after colonoscopy
2 days
Identification of patient groups in which bowel cleansing is more difficult due to concomitant diseases or other conditions (risk groups)
2 days
Tolerability: frequency and severity of adverse events
2 days
Eligibility Criteria
Community sample
You may qualify if:
- 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
You may not qualify if:
- Patients in which prescription of PICOPREP® is contraindicated
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ferring Pharmaceuticalslead
- Ferring Arzneimittel GmbHcollaborator
Study Sites (121)
Investigational Site
Altdorf, Germany
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Altenholz, Germany
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Augsburg, Germany
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Bad Lausick, Germany
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Bad Schwalbach, Germany
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Bayreuth, Germany
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Beckum, Germany
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Berlin, Germany
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Bielefeld, Germany
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Bietigheim, Germany
Private Practice
Bietigheim-Bissingen, Germany
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Bitterfeld-Wolfen, Germany
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Bonn, Germany
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Brandenburg, Germany
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Braunschweig, Germany
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Brinkum, Germany
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Buchholz, Germany
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Butzbach, Germany
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Castrop-Rauxel, Germany
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Cologne, Germany
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Cottbus, Germany
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Dachau, Germany
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Detmold, Germany
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Dingolfing, Germany
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Dippoldswalde, Germany
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Dortmund, Germany
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Dresden, Germany
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Düsseldorf, Germany
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Eberswalde, Germany
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Elsterwerda, Germany
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Erftstadt, Germany
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Erfurt, Germany
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Eschweiler, Germany
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Essen, Germany
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Forchheim, Germany
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Frankfurt, Germany
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Freiburg im Breisgau, Germany
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Friedrichshafen, Germany
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Gelsenkirchen, Germany
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Germering, Germany
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Giessen, Germany
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Giffhorn-Winkel, Germany
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Gilching, Germany
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Goslar, Germany
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Göppingen, Germany
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Grevenbroich, Germany
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Hagen, Germany
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Halle, Germany
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Haltern am See, Germany
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Hamburg, Germany
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Hamelin, Germany
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Hanover, Germany
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Haßloch, Germany
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Hebel, Germany
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Hechingen, Germany
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Heinsberg, Germany
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Herne, Germany
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Herten, Germany
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Herzogenrath, Germany
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Hildesheim, Germany
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Hürth, Germany
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Itzehoe, Germany
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Jena, Germany
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Jerichow, Germany
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Juehlich, Germany
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Karlsruhe, Germany
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Karlstadt am Main, Germany
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Kassel, Germany
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Kiel, Germany
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Kitzingen, Germany
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Koblenz, Germany
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Königstein, Germany
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Königswusterhausen, Germany
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Landshut, Germany
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Leipzig, Germany
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Leverkusen, Germany
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Ludwigshafen, Germany
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Lübeck, Germany
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Magdeburg, Germany
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Mainz, Germany
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Mannheim, Germany
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Mönchengladbach, Germany
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Muenzenberg-Gambach, Germany
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München, Germany
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Münster, Germany
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Neubrandenburg, Germany
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Neumarkt, Germany
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Neumünster, Germany
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Neustadt, Germany
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Nienburg, Germany
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Nuremberg, Germany
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Oldenburg, Germany
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Paderborn, Germany
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Papenburg, Germany
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Plauen, Germany
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Polheim, Germany
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Potsdam, Germany
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Rheda, Germany
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Rinteln, Germany
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Rosenheim, Germany
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Rostock, Germany
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Rottach-Weissach, Germany
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Rottenburg, Germany
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Schwäbisch Hall, Germany
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Schweinfurt, Germany
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Siegen, Germany
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Singen, Germany
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Stade, Germany
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Steinfurt, Germany
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Stuttgart, Germany
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Traunstein, Germany
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Uelzen, Germany
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Varel, Germany
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Waltrop, Germany
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Weißenburg, Germany
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Wertheim am Main, Germany
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Wesseling, Germany
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Wetzlar, Germany
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Wilhelmshaven, Germany
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Wittenberg, Germany
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Wriezen, Germany
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2010
First Posted
October 14, 2010
Study Start
October 1, 2010
Primary Completion
May 1, 2011
Study Completion
July 1, 2011
Last Updated
October 8, 2012
Record last verified: 2012-10