Drug Use-Results Survey on Picoprep® Combination Powder

Bowel Cleansing Clinical Trial

Official title:

Drug Use-Results Survey on Picoprep® Combination Powder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03631446
• Other study ID #: 000311
• Status: Completed
• Start date: August 29, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2021
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1298
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Bowel Cleansing

Intervention

Drug:
• Sodium Picosulfate, Magnesium Oxide and Citric Acid
Combination powder for oral solution

Locations

Country	Name	City	State
Japan	Investigational Site (there may be other sites in this country)	Shibuya	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bowel cleansing assessment for colonoscopy	Assessment of each part of large intestine using a bowel cleanliness rating scale	48 hours after drug administration
Primary	Bowel cleansing assessment for colorectal surgery	Assessment of each part of large intestine using a bowel cleanliness rating scale	48 hours after drug administration