Monitoring of Safety and Tolerance of PICOPREP in Clinical Practice

Bowel Cleanliness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01748591
• Other study ID #: 000062
• Status: Terminated
• Phase: N/A
• First received: November 9, 2012
• Last updated: December 21, 2015
• Start date: May 2012
• Est. completion date: February 2015

Study information

• Verified date: December 2015
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3324
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bowel Cleanliness

Locations

Country	Name	City	State
Czech Republic	Nemocnice Rudolfa a Stefanie	Benešov
Czech Republic	Nemocnice Blansko	Blansko
Czech Republic	Nemocnice Breclav	Breclav
Czech Republic	Soukrmá ambulance	Ceská Lípa
Czech Republic	Decínská nemocnice	Decín
Czech Republic	Nemocnice Havlíckuv Brod	Havlíckuv Brod
Czech Republic	Fakultní nemocnice Hradec Králové	Hradec Králové
Czech Republic	Nemocnice Jablonec	Jablonec nad Nisou
Czech Republic	Nemocnice Jihlava	Jihlava
Czech Republic	Privátní GE	Jihlava
Czech Republic	FN Olomouc	Olomouc
Czech Republic	Všeobecná fakutlní nemocnice	Praha 2
Czech Republic	Sanatorium Sv.Anny	Praha 3
Czech Republic	Privátní GE Praha 4	Praha 4
Czech Republic	Thomayerova nemocnice	Praha 4
Czech Republic	FN Bulovka	Praha 8
Czech Republic	Nemocnice Príbram	Príbram
Czech Republic	Lužická nemocnice	Rumburk
Czech Republic	Nemocnice Tábor	Tábor
Czech Republic	Nemocnice Teplice	Teplice
Czech Republic	Ústecká poliklinika	Ústí nad Labem
Czech Republic	Nemocnice Znojmo	Znojmo

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Frequency of Adverse Events		2 days	Yes
Primary	The Severity of Adverse Events		2 days	Yes
Secondary	Treatment efficacy measured by assessment of the quality of colon cleaning		2 days	No