Compliance and Efficacy in the Use of PICOPREP® (CLEAR)

This study has been completed.
Sponsor:
Collaborator:
Ferring Arzneimittel GmbH
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01220453
First received: October 5, 2010
Last updated: October 5, 2012
Last verified: October 2012
  Purpose

The present trial is aimed to document efficacy (bowel cleanliness), acceptance and tolerability as well as patient comfort in the use of the new bowel cleansing product PICOPREP® in every day practice. In particular, it should be evaluated, whether bowel cleanliness, acceptance, tolerability and patient comfort are affected by specific practice procedures, changes in dose etc.


Condition
Bowel Cleanliness

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Compliance and Efficacy in the Use of PICOPREP® for Bowel Cleansing

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Documentation of the use of PICOPREP® in every day practice [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    Will evaluate efficacy (bowel cleanliness), compliance, acceptance, tolerability and patient comfort


Secondary Outcome Measures:
  • Documentation of patient satisfaction after bowel cleansing [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • Documentation of examiner satisfaction after colonoscopy [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • Identification of patient groups in which bowel cleansing is more difficult due to concomitant diseases or other conditions (risk groups) [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • Tolerability: frequency and severity of adverse events [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]

Enrollment: 2165
Study Start Date: October 2010
Study Completion Date: July 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community sample

Criteria

Inclusion Criteria:

  • Patients receiving PICOPREP® for bowel evacuation prior to endoscopy or surgery
  • Patients who have been informed about the NIS and have given their written consent for participation

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: NCT01220453

  Show 122 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Ferring Arzneimittel GmbH
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01220453     History of Changes
Other Study ID Numbers: FE999169 CS01
Study First Received: October 5, 2010
Last Updated: October 5, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on October 21, 2014