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

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ClinicalTrials.gov Identifier: NCT01292109
Recruitment Status : Completed
First Posted : February 9, 2011
Last Update Posted : February 9, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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 Design

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
Primary Completion Date : September 2011
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Groups and Cohorts

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®


Outcome Measures

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 ]

Eligibility Criteria

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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients in which prescription of PICOPREP® is contraindicated
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01292109


Locations
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
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
More Information

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov 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:
endoscopy
colonoscopy
preparation for surgery

Additional relevant MeSH terms:
Picosulfate sodium
Cathartics
Gastrointestinal Agents