Drug Use-Results Survey on Picoprep® Combination Powder

January 14, 2022 updated by: Ferring Pharmaceuticals
The purpose of this survey is to confirm safety and efficacy with patients who are administered the Picoprep® for cleansing of intestinal contents for preparation of colonoscopy and colorectal surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1298

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Shibuya, Tokyo, Japan
        • Investigational site (there may be other sites in this country)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients being prepared for colonoscopy and colorectal surgery

Description

Inclusion Criteria:

Patients who are administered the Picoprep® for cleansing of intestinal contents for preparation of colonoscopy and colorectal surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients administered Picoprep® for bowel cleansing
Patients administered Sodium Picosulfate, Magnesium Oxide and Citric Acid for bowel cleansing
Drug: Sodium Picosulfate, Magnesium Oxide and Citric Acid
Combination powder for oral solution
Other Names:
  • Picoprep®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bowel cleansing assessment for colonoscopy
Time Frame: 48 hours after drug administration
Assessment of each part of large intestine using a bowel cleanliness rating scale
48 hours after drug administration
Bowel cleansing assessment for colorectal surgery
Time Frame: 48 hours after drug administration
Assessment of each part of large intestine using a bowel cleanliness rating scale
48 hours after drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2017

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

August 13, 2018

First Submitted That Met QC Criteria

August 13, 2018

First Posted (Actual)

August 15, 2018

Study Record Updates

Last Update Posted (Actual)

January 18, 2022

Last Update Submitted That Met QC Criteria

January 14, 2022

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000311

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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