Compliance and Efficacy in the Use of PICOPREP® (CLEAR)

October 5, 2012 updated by: Ferring Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2165

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • 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
        • Investigational Site
      • Bietigheim-Bissingen, Germany
        • Private Practice
      • 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, Germany
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community sample

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Documentation of patient satisfaction after bowel cleansing
Time Frame: 2 days
2 days
Documentation of examiner satisfaction after colonoscopy
Time Frame: 2 days
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
2 days
Tolerability: frequency and severity of adverse events
Time Frame: 2 days
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Collaborators

Ferring Arzneimittel GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

October 5, 2010

First Submitted That Met QC Criteria

October 13, 2010

First Posted (Estimate)

October 14, 2010

Study Record Updates

Last Update Posted (Estimate)

October 8, 2012

Last Update Submitted That Met QC Criteria

October 5, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • FE999169 CS01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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