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:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01748591
First received: November 9, 2012
Last updated: February 5, 2015
Last verified: February 2015
  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 ] [ Designated as safety issue: Yes ]
  • The Severity of Adverse Events [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Treatment efficacy measured by assessment of the quality of colon cleaning [ Time Frame: 2 days ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Privátní GE
Jihlava, Czech Republic
Nemocnice Jihlava
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

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01748591     History of Changes
Other Study ID Numbers: 000062
Study First Received: November 9, 2012
Last Updated: February 5, 2015
Health Authority: Czech Republic: State Institute for Drug Control

ClinicalTrials.gov processed this record on March 25, 2015