Monitoring of Safety and Tolerance of PICOPREP in Clinical Practice

December 21, 2015 updated by: Ferring Pharmaceuticals

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

A Confirmation of Safety, Tolerance and Efficacy of PICOPREP in Clinical Practice.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

3324

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
      • Benešov, Czech Republic
        • Nemocnice Rudolfa a Stefanie
      • Blansko, Czech Republic
        • Nemocnice Blansko
      • Břeclav, Czech Republic
        • Nemocnice Břeclav
      • Děčín, Czech Republic
        • Děčínská nemocnice
      • Havlíčkův Brod, Czech Republic
        • Nemocnice Havlíčkův Brod
      • Hradec Králové, Czech Republic
        • Fakultni nemocnice Hradec Kralove
      • Jablonec nad Nisou, Czech Republic
        • Nemocnice Jablonec
      • Jihlava, Czech Republic
        • Nemocnice Jihlava
      • Jihlava, Czech Republic
        • Privátní GE
      • Olomouc, Czech Republic
        • FN Olomouc
      • Praha 2, Czech Republic
        • Všeobecná fakutlní nemocnice
      • Praha 3, Czech Republic
        • Sanatorium Sv.Anny
      • Praha 4, Czech Republic
        • Privátní GE Praha 4
      • Praha 4, Czech Republic
        • Thomayerova nemocnice
      • Praha 8, Czech Republic
        • FN Bulovka
      • Příbram, Czech Republic
        • Nemocnice Příbram
      • Rumburk, Czech Republic
        • Lužická nemocnice
      • Teplice, Czech Republic
        • Nemocnice Teplice
      • Tábor, Czech Republic
        • Nemocnice Tábor
      • Znojmo, Czech Republic
        • Nemocnice Znojmo
      • Ústí nad Labem, Czech Republic
        • Ústecká poliklinika
      • Česká Lípa, Czech Republic
        • Soukrmá ambulance

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients eligible for endoscopic examination or surgery

Description

Inclusion Criteria:

  • Patients eligible for treatment with PICOPREP® for bowel cleansing prior to endoscopic examination 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
PICOPREP treatment
PICOPREP powder for oral solution according to standard clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Frequency of Adverse Events
Time Frame: 2 days
2 days
The Severity of Adverse Events
Time Frame: 2 days
2 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Treatment efficacy measured by assessment of the quality of colon cleaning
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

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

May 1, 2012

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

November 9, 2012

First Submitted That Met QC Criteria

December 11, 2012

First Posted (Estimate)

December 12, 2012

Study Record Updates

Last Update Posted (Estimate)

December 22, 2015

Last Update Submitted That Met QC Criteria

December 21, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 000062

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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