Monitoring of Safety and Tolerance of PICOPREP in Clinical Practice

Overview

A Confirmation of Safety, Tolerance and Efficacy of PICOPREP in Clinical Practice.

Full Title of Study: “A Study of PICOPREP in Patients Needing to Clean the Bowel Prior to X-ray Examination, Endoscopy or Surgery”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 2015

Arms, Groups and Cohorts

  • PICOPREP treatment
    • PICOPREP powder for oral solution according to standard clinical practice

Clinical Trial Outcome Measures

Primary Measures

  • The Frequency of Adverse Events
    • Time Frame: 2 days
  • The Severity of Adverse Events
    • Time Frame: 2 days

Secondary Measures

  • Treatment efficacy measured by assessment of the quality of colon cleaning
    • Time Frame: 2 days

Participating in This Clinical Trial

Inclusion Criteria

  • Patients eligible for treatment with PICOPREP┬« for bowel cleansing prior to endoscopic examination or surgery Exclusion Criteria:

  • Patients in which prescription of PICOPREP┬« is contraindicated

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ferring Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Development Support, Study Director, Ferring Pharmaceuticals

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