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
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: 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 July 24, 2014