NCT03631446

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,298

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 29, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 18, 2022

Status Verified

October 1, 2021

Enrollment Period

4.3 years

First QC Date

August 13, 2018

Last Update Submit

January 14, 2022

Conditions

Bowel Cleansing

Outcome Measures

Primary Outcomes (2)

  • Bowel cleansing assessment for colonoscopy

    Assessment of each part of large intestine using a bowel cleanliness rating scale

    48 hours after drug administration

  • Bowel cleansing assessment for colorectal surgery

    Assessment of each part of large intestine using a bowel cleanliness rating scale

    48 hours after drug administration

Study Arms (1)

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

Interventions

Sodium Picosulfate, Magnesium Oxide and Citric AcidDRUG

Combination powder for oral solution

Also known as: Picoprep®
Patients administered Picoprep® for bowel cleansing

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients being prepared for colonoscopy and colorectal surgery

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigational Site (there may be other sites in this country)

Shibuya City, Tokyo, Japan

Location

MeSH Terms

Interventions

picosulfate sodiumMagnesium OxideCitric Acid

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsOxidesOxygen CompoundsCitratesTricarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Global Clinical Compliance

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2018

First Posted

August 15, 2018

Study Start

August 29, 2017

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 18, 2022

Record last verified: 2021-10

Locations

JP(1)