A Study of PICOPREP in Patients Needed to Clean the Bowel Prior to X-ray Examination, Endoscopy or Surgery.
This study has been completed.
Information provided by (Responsible Party):
First received: February 8, 2011
Last updated: February 8, 2012
Last verified: February 2012
The study serves as a confirmation of safety, tolerance and efficacy of PICOPREP in clinical practice.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Compliance and Efficacy in the Use of PICOPREP for Bowel Cleansing|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Ferring Pharmaceuticals:
Primary Outcome Measures:
- Documentation of use PICOPREP in everyday practice [ Time Frame: Day 0 - 2 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Participant satisfaction and compliance after bowel cleansing [ Time Frame: Days 0-2 ] [ Designated as safety issue: No ]
- Participants with adverse events reported by frequency and severity [ Time Frame: Days 1-2 ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2010|
|Study Completion Date:||February 2012|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Drug: sodium picosulphate
Sodium picosulphate (PICOPREP®) taken by participant prior to X-ray examination, endoscopy or surgery.
Other Name: PICOPREP®
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292109
|Ostrava - Poruba, Czech Republic|
|Pilsen, Czech Republic|
|Iscare - Prague 7|
|Prague 7, Czech Republic|
Sponsors and Collaborators
|Study Director:||Clinical Development Support||Ferring Pharmaceuticals|