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Monitoring of Safety and Tolerance of PICOPREP in Clinical Practice

This study has been terminated.
(Terminated due to problems enrolling adequate number of patients.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01748591
First Posted: December 12, 2012
Last Update Posted: December 22, 2015
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.
Information provided by (Responsible Party):
Ferring Pharmaceuticals
  Purpose
A Confirmation of Safety, Tolerance and Efficacy of PICOPREP in Clinical Practice.

Condition
Bowel Cleanliness

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study of PICOPREP in Patients Needing to Clean the Bowel Prior to X-ray Examination, Endoscopy or Surgery

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • The Frequency of Adverse Events [ Time Frame: 2 days ]
  • The Severity of Adverse Events [ Time Frame: 2 days ]

Secondary Outcome Measures:
  • Treatment efficacy measured by assessment of the quality of colon cleaning [ Time Frame: 2 days ]

Enrollment: 3324
Study Start Date: May 2012
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
PICOPREP treatment
PICOPREP powder for oral solution according to standard clinical practice

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients eligible for endoscopic examination or surgery
Criteria

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
  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): NCT01748591


Locations
Czech Republic
Nemocnice Rudolfa a Stefanie
Benešov, Czech Republic
Nemocnice Blansko
Blansko, Czech Republic
Nemocnice Břeclav
Břeclav, Czech Republic
Děčínská nemocnice
Děčín, Czech Republic
Nemocnice Havlíčkův Brod
Havlíčkův Brod, Czech Republic
Fakultní nemocnice Hradec Králové
Hradec Králové, Czech Republic
Nemocnice Jablonec
Jablonec nad Nisou, Czech Republic
Nemocnice Jihlava
Jihlava, Czech Republic
Privátní GE
Jihlava, Czech Republic
FN Olomouc
Olomouc, Czech Republic
Všeobecná fakutlní nemocnice
Praha 2, Czech Republic
Sanatorium Sv.Anny
Praha 3, Czech Republic
Privátní GE Praha 4
Praha 4, Czech Republic
Thomayerova nemocnice
Praha 4, Czech Republic
FN Bulovka
Praha 8, Czech Republic
Nemocnice Příbram
Příbram, Czech Republic
Lužická nemocnice
Rumburk, Czech Republic
Nemocnice Teplice
Teplice, Czech Republic
Nemocnice Tábor
Tábor, Czech Republic
Nemocnice Znojmo
Znojmo, Czech Republic
Ústecká poliklinika
Ústí nad Labem, Czech Republic
Soukrmá ambulance
Česká Lípa, Czech Republic
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01748591     History of Changes
Other Study ID Numbers: 000062
First Submitted: November 9, 2012
First Posted: December 12, 2012
Last Update Posted: December 22, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Picosulfate sodium
Cathartics
Gastrointestinal Agents