NCT01220453

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,165

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2010

Shorter than P25 for all trials

Geographic Reach
1 country

121 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2010

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 14, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

October 8, 2012

Status Verified

October 1, 2012

Enrollment Period

7 months

First QC Date

October 5, 2010

Last Update Submit

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (121)

Investigational Site

Altdorf, Germany

Location

Investigational Site

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

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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

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Study Officials

  • Clinical Development Support

    Ferring Pharmaceuticals

    STUDY DIRECTOR

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

Locations