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

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ClinicalTrials.gov Identifier: NCT01220453
Recruitment Status : Completed
First Posted : October 14, 2010
Last Update Posted : October 8, 2012
Sponsor:
Collaborator:
Ferring Arzneimittel GmbH
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief Summary:
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 or disease
Bowel Cleanliness

Study Type : Observational
Actual Enrollment : 2165 participants
Time Perspective: Prospective
Official Title: Compliance and Efficacy in the Use of PICOPREP® for Bowel Cleansing
Study Start Date : October 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 :
  1. Documentation of patient satisfaction after bowel cleansing [ Time Frame: 2 days ]
  2. Documentation of examiner satisfaction after colonoscopy [ Time Frame: 2 days ]
  3. Identification of patient groups in which bowel cleansing is more difficult due to concomitant diseases or other conditions (risk groups) [ Time Frame: 2 days ]
  4. Tolerability: frequency and severity of adverse events [ Time Frame: 2 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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

Additional relevant MeSH terms:
Picosulfate sodium
Cathartics
Gastrointestinal Agents