Clinical trial NCT01220453: Compliance and Efficacy in the Use of PICOPREP®
Official title: Compliance and Efficacy in the Use of PICOPREP® for Bowel Cleansing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bowel Cleanliness
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Ferring Arzneimittel GmbH
First posted: 2010-10-14
Enrollment: 2165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients in which prescription of PICOPREP® is contraindicated

Primary outcomes:
measure: Documentation of the use of PICOPREP® in every day practice
timeFrame: 2 days
Secondary outcomes:
measure: Documentation of patient satisfaction after bowel cleansing
timeFrame: 2 days
measure: Documentation of examiner satisfaction after colonoscopy
timeFrame: 2 days
measure: Identification of patient groups in which bowel cleansing is more difficult due to concomitant diseases or other conditions (risk groups)
timeFrame: 2 days
measure: Tolerability: frequency and severity of adverse events
timeFrame: 2 days
Other outcomes:
Locations:
city: Altdorf
country: Germany
facility: Investigational Site
city: Altenholz
country: Germany
facility: Investigational Site
city: Augsburg
country: Germany
facility: Investigational Site
city: Bad Lausick
country: Germany
facility: Investigational Site
city: Bad Schwalbach
country: Germany
facility: Investigational Site
city: Bayreuth
country: Germany
facility: Investigational Site
city: Beckum
country: Germany
facility: Investigational Site
city: Berlin
country: Germany
facility: Investigational Site
city: Bielefeld
country: Germany
facility: Investigational Site
city: Bietigheim-Bissingen
country: Germany
facility: Private Practice
city: Bietigheim
country: Germany
facility: Investigational Site
city: Bitterfeld
country: Germany
facility: Investigational Site
city: Bonn
country: Germany
facility: Investigational Site
city: Brandenburg
country: Germany
facility: Investigational Site
city: Braunschweig
country: Germany
facility: Investigational Site
city: Brinkum
country: Germany
facility: Investigational Site
city: Buchholz
country: Germany
facility: Investigational Site
city: Butzbach
country: Germany
facility: Investigational Site
city: Castrop-Rauxel
country: Germany
facility: Investigational Site
city: Cottbus
country: Germany
facility: Investigational Site
city: Dachau
country: Germany
facility: Investigational Site
city: Detmold
country: Germany
facility: Investigational Site
city: Dingolfing
country: Germany
facility: Investigational Site
city: Dippoldswalde
country: Germany
facility: Investigational Site
city: Dortmund
country: Germany
facility: Investigational Site
city: Dresden
country: Germany
facility: Investigational Site
city: Duesseldorf
country: Germany
facility: Investigational Site
city: Dusseldorf
country: Germany
facility: Investigational Site
city: Eberswalde
country: Germany
facility: Investigational Site
city: Elsterwerda
country: Germany
facility: Investigational Site
city: Erftstadt
country: Germany
facility: Investigational Site
city: Erfurt
country: Germany
facility: Investigational Site
city: Eschweiler
country: Germany
facility: Investigational Site
city: Essen
country: Germany
facility: Investigational Site
city: Forchheim
country: Germany
facility: Investigational Site
city: Frankfurt
country: Germany
facility: Investigational Site
city: Freiburg
country: Germany
facility: Investigational Site
city: Friedrichshafen
country: Germany
facility: Investigational Site
city: Gelsenkirchen
country: Germany
facility: Investigational Site
city: Germering
country: Germany
facility: Investigational Site
city: Giessen
country: Germany
facility: Investigational Site
city: Giffhorn-Winkel
country: Germany
facility: Investigational Site
city: Gilching
country: Germany
facility: Investigational Site
city: Goeppingen
country: Germany
facility: Investigational Site
city: Goslar
country: Germany
facility: Investigational Site
city: Grevenbroich
country: Germany
facility: Investigational Site
city: Hagen
country: Germany
facility: Investigational Site
city: Halle
country: Germany
facility: Investigational Site
city: Haltern am See
country: Germany
facility: Investigational Site
city: Hamburg
country: Germany
facility: Investigational Site
city: Hameln
country: Germany
facility: Investigational Site
city: Hannover
country: Germany
facility: Investigational Site
city: Hassloch
country: Germany
facility: Investigational Site
city: Hebel
country: Germany
facility: Investigational Site
city: Hechingen
country: Germany
facility: Investigational site
city: Heinsberg
country: Germany
facility: Investigational Site
city: Herne
country: Germany
facility: Investigational Site
city: Herten
country: Germany
facility: Investigational Site
city: Herzogenrath
country: Germany
facility: Investigational Site
city: Hildesheim
country: Germany
facility: Investigational Site
city: Huerth
country: Germany
facility: Investigational Site
city: Itzehoe
country: Germany
facility: Investigational Site
city: Jena
country: Germany
facility: Investigational Site
city: Jerichow
country: Germany
facility: Investigational Site
city: Juehlich
country: Germany
facility: Investigational Site
city: Karlsruhe
country: Germany
facility: Investigational Site
city: Karlstadt
country: Germany
facility: Investigational Site
city: Kassel
country: Germany
facility: Investigational Site
city: Kiel
country: Germany
facility: Investigational Site
city: Kitzingen
country: Germany
facility: Investigational Site
city: Koblenz
country: Germany
facility: Investigational Site
city: Koeln
country: Germany
facility: Investigational Site
city: Koenigstein
country: Germany
facility: Investigational Site
city: Königswusterhausen
country: Germany
facility: Investigational Site
city: Landshut
country: Germany
facility: Investigational Site
city: Leipzig
country: Germany
facility: Investigational Site
city: Leverkusen
country: Germany
facility: Investigational Site
city: Ludwigshafen
country: Germany
facility: Investigational Site
city: Luebeck
country: Germany
facility: Investigational Site
city: Lutherstadt-Wittenberg
country: Germany
facility: Investigational Site
city: Magdeburg
country: Germany
facility: Investigational Site
city: Mainz
country: Germany
facility: Investigational Site
city: Mannheim
country: Germany
facility: Investigational Site
city: Moenchengladbach
country: Germany
facility: Investigational Site
city: Muenchen
country: Germany
facility: Investigational Site
city: Muenster
country: Germany
facility: Investigational Site
city: Muenzenberg-Gambach
country: Germany
facility: Investigational Site
city: Neubrandenburg
country: Germany
facility: Investigational Site
city: Neumarkt
country: Germany
facility: Investigational Site
city: Neumuenster
country: Germany
facility: Investigational Site
city: Neustadt
country: Germany
facility: Investigational Site
city: Nienburg
country: Germany
facility: Investigational Site
city: Nuernberg
country: Germany
facility: Investigational Site
city: Oldenburg
country: Germany
facility: Investigational Site
city: Paderborn
country: Germany
facility: Investigational Site
city: Papenburg
country: Germany
facility: Investigational Site
city: Plauen
country: Germany
facility: Investigational Site
city: Polheim
country: Germany
facility: Investigational Site
city: Potsdam
country: Germany
facility: Investigational Site
city: Rheda
country: Germany
facility: Investigational Site
city: Rinteln
country: Germany
facility: Investigational Site
city: Rosenheim
country: Germany
facility: Investigational Site
city: Rostock
country: Germany
facility: Investigational Site
city: Rottach-Weissach
country: Germany
facility: Investigational Site
city: Rottenburg
country: Germany
facility: Investigational Site
city: Schwaebisch-Hall
country: Germany
facility: Investigational Site
city: Schweinfurt
country: Germany
facility: Investigational Site
city: Siegen
country: Germany
facility: Investigational Site
city: Singen
country: Germany
facility: Investigational site
city: Stade
country: Germany
facility: Investigational Site
city: Steinfurt
country: Germany
facility: Investigational Site
city: Stuttgart
country: Germany
facility: Investigational Site
city: Traunstein
country: Germany
facility: Investigational Site
city: Uelzen
country: Germany
facility: Investigational Site
city: Varel
country: Germany
facility: Investigational Site
city: Waltrop
country: Germany
facility: Investigational Site
city: Weissenburg
country: Germany
facility: Investigational Site
city: Wertheim
country: Germany
facility: Investigational Site
city: Wesseling
country: Germany
facility: Investigational Site
city: Wetzlar
country: Germany
facility: Investigational Site
city: Wilhelmshaven
country: Germany
facility: Investigational Site
city: Wriezen
country: Germany
facility: Investigational Site
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: