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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01220453
First Posted: October 14, 2010
Last Update Posted: October 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ferring Arzneimittel GmbH
Information provided by (Responsible Party):
Ferring Pharmaceuticals
  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

Resource links provided by NLM:


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 ]
    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 ]
  • Documentation of examiner satisfaction after colonoscopy [ Time Frame: 2 days ]
  • Identification of patient groups in which bowel cleansing is more difficult due to concomitant diseases or other conditions (risk groups) [ Time Frame: 2 days ]
  • Tolerability: frequency and severity of adverse events [ Time Frame: 2 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01220453


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

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01220453     History of Changes
Other Study ID Numbers: FE999169 CS01
First Submitted: October 5, 2010
First Posted: October 14, 2010
Last Update Posted: October 8, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Picosulfate sodium
Cathartics
Gastrointestinal Agents