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: December 21, 2015
Last verified: December 2015

November 9, 2012
December 21, 2015
May 2012
February 2015   (final data collection date for primary outcome measure)
  • 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 ]
The Frequency and Severity of Adverse Events [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01748591 on ClinicalTrials.gov Archive Site
Treatment efficacy measured by assessment of the quality of colon cleaning [ Time Frame: 2 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Monitoring of Safety and Tolerance of PICOPREP in Clinical Practice
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients eligible for endoscopic examination or surgery
Bowel Cleanliness
Not Provided
PICOPREP treatment
PICOPREP powder for oral solution according to standard clinical practice
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3324
February 2015
February 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
NCT01748591
000062
No
Not Provided
Not Provided
Ferring Pharmaceuticals
Ferring Pharmaceuticals
Not Provided
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP