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

Bowel Cleanliness Clinical Trial

Official title:

Compliance and Efficacy in the Use of PICOPREP for Bowel Cleansing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01292109
• Other study ID #: FE999169 CS03
• Status: Completed
• Phase: N/A
• First received: February 8, 2011
• Last updated: February 8, 2012
• Start date: December 2010
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Observational

Clinical Trial Summary

The study serves as a confirmation of safety, tolerance and efficacy of PICOPREP in clinical practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: February 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients receiving PICOPREP® for bowel evacuation prior to endoscopy or surgery

Exclusion Criteria:

• Patients in which prescription of PICOPREP® is contraindicated

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bowel Cleanliness

Intervention

Drug:
• sodium picosulphate
Sodium picosulphate (PICOPREP®) taken by participant prior to X-ray examination, endoscopy or surgery.

Locations

Country	Name	City	State
Czech Republic	University Hospital	Ostrava - Poruba
Czech Republic	University Hospital	Pilsen
Czech Republic	Iscare - Prague 7	Prague 7

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Documentation of use PICOPREP in everyday practice		Day 0 - 2	No
Secondary	Participant satisfaction and compliance after bowel cleansing		Days 0-2	No
Secondary	Participants with adverse events reported by frequency and severity		Days 1-2	Yes