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

February 8, 2012 updated by: Ferring Pharmaceuticals

Compliance and Efficacy in the Use of PICOPREP for Bowel Cleansing

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

252

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

  • Czech Republic
      • Ostrava - Poruba, Czech Republic
        • University Hospital
      • Pilsen, Czech Republic
        • University Hospital
      • Prague 7, Czech Republic
        • Iscare - Prague 7

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients about to undergo X-ray examination, endoscopy or surgery.

Description

Inclusion Criteria:

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Documentation of use PICOPREP in everyday practice
Time Frame: Day 0 - 2
Day 0 - 2

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Ferring Pharmaceuticals

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

December 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

February 8, 2011

First Submitted That Met QC Criteria

February 8, 2011

First Posted (Estimate)

February 9, 2011

Study Record Updates

Last Update Posted (Estimate)

February 9, 2012

Last Update Submitted That Met QC Criteria

February 8, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FE999169 CS03

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.

Clinical Trials on Bowel Cleanliness

Clinical Trials on sodium picosulphate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe