Compliance and Efficacy in the Use of PICOPREP®

Bowel Cleanliness Clinical Trial

— CLEAR  

Official title:

Compliance and Efficacy in the Use of PICOPREP® for Bowel Cleansing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01220453
• Other study ID #: FE999169 CS01
• Status: Completed
• Phase: N/A
• First received: October 5, 2010
• Last updated: October 5, 2012
• Start date: October 2010
• Est. completion date: July 2011

Study information

• Verified date: October 2012
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical 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. In particular, it should be evaluated, whether bowel cleanliness, acceptance, tolerability and patient comfort are affected by specific practice procedures, changes in dose etc.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2165
• Est. completion date: July 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Bowel Cleanliness

Locations

Country	Name	City	State
Germany	Investigational Site	Altdorf
Germany	Investigational Site	Altenholz
Germany	Investigational Site	Augsburg
Germany	Investigational Site	Bad Lausick
Germany	Investigational Site	Bad Schwalbach
Germany	Investigational Site	Bayreuth
Germany	Investigational Site	Beckum
Germany	Investigational Site	Berlin
Germany	Investigational Site	Bielefeld
Germany	Investigational Site	Bietigheim
Germany	Private Practice	Bietigheim-Bissingen
Germany	Investigational Site	Bitterfeld
Germany	Investigational Site	Bonn
Germany	Investigational Site	Brandenburg
Germany	Investigational Site	Braunschweig
Germany	Investigational Site	Brinkum
Germany	Investigational Site	Buchholz
Germany	Investigational Site	Butzbach
Germany	Investigational Site	Castrop-Rauxel
Germany	Investigational Site	Cottbus
Germany	Investigational Site	Dachau
Germany	Investigational Site	Detmold
Germany	Investigational Site	Dingolfing
Germany	Investigational Site	Dippoldswalde
Germany	Investigational Site	Dortmund
Germany	Investigational Site	Dresden
Germany	Investigational Site	Duesseldorf
Germany	Investigational Site	Dusseldorf
Germany	Investigational Site	Eberswalde
Germany	Investigational Site	Elsterwerda
Germany	Investigational Site	Erftstadt
Germany	Investigational Site	Erfurt
Germany	Investigational Site	Eschweiler
Germany	Investigational Site	Essen
Germany	Investigational Site	Forchheim
Germany	Investigational Site	Frankfurt
Germany	Investigational Site	Freiburg
Germany	Investigational Site	Friedrichshafen
Germany	Investigational Site	Gelsenkirchen
Germany	Investigational Site	Germering
Germany	Investigational Site	Giessen
Germany	Investigational Site	Giffhorn-Winkel
Germany	Investigational Site	Gilching
Germany	Investigational Site	Goeppingen
Germany	Investigational Site	Goslar
Germany	Investigational Site	Grevenbroich
Germany	Investigational Site	Hagen
Germany	Investigational Site	Halle
Germany	Investigational Site	Haltern am See
Germany	Investigational Site	Hamburg
Germany	Investigational Site	Hameln
Germany	Investigational Site	Hannover
Germany	Investigational Site	Hassloch
Germany	Investigational Site	Hebel
Germany	Investigational site	Hechingen
Germany	Investigational Site	Heinsberg
Germany	Investigational Site	Herne
Germany	Investigational Site	Herten
Germany	Investigational Site	Herzogenrath
Germany	Investigational Site	Hildesheim
Germany	Investigational Site	Huerth
Germany	Investigational Site	Itzehoe
Germany	Investigational Site	Jena
Germany	Investigational Site	Jerichow
Germany	Investigational Site	Juehlich
Germany	Investigational Site	Karlsruhe
Germany	Investigational Site	Karlstadt
Germany	Investigational Site	Kassel
Germany	Investigational Site	Kiel
Germany	Investigational Site	Kitzingen
Germany	Investigational Site	Koblenz
Germany	Investigational Site	Koeln
Germany	Investigational Site	Koenigstein
Germany	Investigational Site	Königswusterhausen
Germany	Investigational Site	Landshut
Germany	Investigational Site	Leipzig
Germany	Investigational Site	Leverkusen
Germany	Investigational Site	Ludwigshafen
Germany	Investigational Site	Luebeck
Germany	Investigational Site	Lutherstadt-Wittenberg
Germany	Investigational Site	Magdeburg
Germany	Investigational Site	Mainz
Germany	Investigational Site	Mannheim
Germany	Investigational Site	Moenchengladbach
Germany	Investigational Site	Muenchen
Germany	Investigational Site	Muenster
Germany	Investigational Site	Muenzenberg-Gambach
Germany	Investigational Site	Neubrandenburg
Germany	Investigational Site	Neumarkt
Germany	Investigational Site	Neumuenster
Germany	Investigational Site	Neustadt
Germany	Investigational Site	Nienburg
Germany	Investigational Site	Nuernberg
Germany	Investigational Site	Oldenburg
Germany	Investigational Site	Paderborn
Germany	Investigational Site	Papenburg
Germany	Investigational Site	Plauen
Germany	Investigational Site	Polheim
Germany	Investigational Site	Potsdam
Germany	Investigational Site	Rheda
Germany	Investigational Site	Rinteln
Germany	Investigational Site	Rosenheim
Germany	Investigational Site	Rostock
Germany	Investigational Site	Rottach-Weissach
Germany	Investigational Site	Rottenburg
Germany	Investigational Site	Schwaebisch-Hall
Germany	Investigational Site	Schweinfurt
Germany	Investigational Site	Siegen
Germany	Investigational site	Singen
Germany	Investigational Site	Stade
Germany	Investigational Site	Steinfurt
Germany	Investigational Site	Stuttgart
Germany	Investigational Site	Traunstein
Germany	Investigational Site	Uelzen
Germany	Investigational Site	Varel
Germany	Investigational Site	Waltrop
Germany	Investigational Site	Weissenburg
Germany	Investigational Site	Wertheim
Germany	Investigational Site	Wesseling
Germany	Investigational Site	Wetzlar
Germany	Investigational Site	Wilhelmshaven
Germany	Investigational Site	Wriezen

Sponsors (2)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals	Ferring Arzneimittel GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Documentation of the use of PICOPREP® in every day practice	Will evaluate efficacy (bowel cleanliness), compliance, acceptance, tolerability and patient comfort	2 days	No
Secondary	Documentation of patient satisfaction after bowel cleansing		2 days	No
Secondary	Documentation of examiner satisfaction after colonoscopy		2 days	No
Secondary	Identification of patient groups in which bowel cleansing is more difficult due to concomitant diseases or other conditions (risk groups)		2 days	No
Secondary	Tolerability: frequency and severity of adverse events		2 days	Yes