A Study of PICOPREP in Patients Needed to Clean the Bowel Prior to X-ray Examination, Endoscopy or Surgery.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01292109
Recruitment Status : Completed
First Posted : February 9, 2011
Last Update Posted : February 9, 2012
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief Summary:
The study serves as a confirmation of safety, tolerance and efficacy of PICOPREP in clinical practice.

Condition or disease Intervention/treatment
Bowel Cleanliness Drug: sodium picosulphate

Study Type : Observational
Actual Enrollment : 252 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Compliance and Efficacy in the Use of PICOPREP for Bowel Cleansing
Study Start Date : December 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Group/Cohort Intervention/treatment
PICOPREP® Drug: sodium picosulphate
Sodium picosulphate (PICOPREP®) taken by participant prior to X-ray examination, endoscopy or surgery.
Other Name: PICOPREP®

Primary Outcome Measures :
  1. Documentation of use PICOPREP in everyday practice [ Time Frame: Day 0 - 2 ]

Secondary Outcome Measures :
  1. Participant satisfaction and compliance after bowel cleansing [ Time Frame: Days 0-2 ]
  2. Participants with adverse events reported by frequency and severity [ Time Frame: Days 1-2 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients about to undergo X-ray examination, endoscopy or surgery.

Inclusion Criteria:

  • Patients receiving PICOPREP® for bowel evacuation prior to endoscopy or surgery

Exclusion Criteria:

  • Patients in which prescription of PICOPREP® is contraindicated

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01292109

Czech Republic
University Hospital
Ostrava - Poruba, Czech Republic
University Hospital
Pilsen, Czech Republic
Iscare - Prague 7
Prague 7, Czech Republic
Sponsors and Collaborators
Ferring Pharmaceuticals
Study Director: Clinical Development Support Ferring Pharmaceuticals

Responsible Party: Ferring Pharmaceuticals Identifier: NCT01292109     History of Changes
Other Study ID Numbers: FE999169 CS03
First Posted: February 9, 2011    Key Record Dates
Last Update Posted: February 9, 2012
Last Verified: February 2012

Keywords provided by Ferring Pharmaceuticals:
preparation for surgery

Additional relevant MeSH terms:
Picosulfate sodium
Gastrointestinal Agents