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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01292109
First received: February 8, 2011
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention
Bowel Cleanliness
Drug: sodium picosulphate

Study Type: Observational
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:


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 ]

Enrollment: 252
Study Start Date: December 2010
Study Completion Date: February 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
PICOPREP® Drug: sodium picosulphate
Sodium picosulphate (PICOPREP®) taken by participant prior to X-ray examination, endoscopy or surgery.
Other Name: PICOPREP®

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients about to undergo X-ray examination, endoscopy or surgery.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients in which prescription of PICOPREP® is contraindicated
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292109

Locations
Czech Republic
University Hospital
Ostrava - Poruba, Czech Republic
University Hospital
Pilsen, Czech Republic
Iscare - Prague 7
Prague 7, 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: NCT01292109     History of Changes
Other Study ID Numbers: FE999169 CS03
Study First Received: February 8, 2011
Last Updated: February 8, 2012
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by Ferring Pharmaceuticals:
endoscopy
colonoscopy
preparation for surgery

Additional relevant MeSH terms:
Picosulfate sodium
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014