Monitoring of Safety and Tolerance of PICOPREP in Clinical Practice

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Ferring Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01748591
First received: November 9, 2012
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

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


Condition
Bowel Cleanliness

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study of PICOPREP in Patients Needing to Clean the Bowel Prior to X-ray Examination, Endoscopy or Surgery

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • The Frequency of Adverse Events [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
  • The Severity of Adverse Events [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Treatment efficacy measured by assessment of the quality of colon cleaning [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 14000
Study Start Date: May 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
PICOPREP treatment
PICOPREP powder for oral solution according to standard clinical practice

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients eligible for endoscopic examination or surgery

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01748591

Contacts
Contact: Clinical Development Support DK0-Disclosure@ferring.com

Locations
Czech Republic
Nemocnice Rudolfa a Stefanie Recruiting
Benešov, Czech Republic
Nemocnice Blansko Recruiting
Blansko, Czech Republic
Nemocnice Břeclav Recruiting
Břeclav, Czech Republic
Děčínská nemocnice Recruiting
Děčín, Czech Republic
Nemocnice Havlíčkův Brod Recruiting
Havlíčkův Brod, Czech Republic
Fakultní nemocnice Hradec Králové Recruiting
Hradec Králové, Czech Republic
Nemocnice Jablonec Recruiting
Jablonec nad Nisou, Czech Republic
Nemocnice Jihlava Recruiting
Jihlava, Czech Republic
Privátní GE Recruiting
Jihlava, Czech Republic
FN Olomouc Recruiting
Olomouc, Czech Republic
Všeobecná fakutlní nemocnice Recruiting
Praha 2, Czech Republic
Sanatorium Sv.Anny Recruiting
Praha 3, Czech Republic
Thomayerova nemocnice Recruiting
Praha 4, Czech Republic
Privátní GE Praha 4 Recruiting
Praha 4, Czech Republic
FN Bulovka Recruiting
Praha 8, Czech Republic
Nemocnice Příbram Recruiting
Příbram, Czech Republic
Lužická nemocnice Recruiting
Rumburk, Czech Republic
Nemocnice Teplice Recruiting
Teplice, Czech Republic
Nemocnice Tábor Recruiting
Tábor, Czech Republic
Nemocnice Znojmo Recruiting
Znojmo, Czech Republic
Ústecká poliklinika Recruiting
Ústí nad Labem, Czech Republic
Soukrmá ambulance Recruiting
Česká Lípa, Czech Republic
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01748591     History of Changes
Other Study ID Numbers: 000062
Study First Received: November 9, 2012
Last Updated: April 22, 2014
Health Authority: Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Picosulfate sodium
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014