Monitoring of Safety and Tolerance of PICOPREP in Clinical Practice
This study is currently recruiting participants.
Verified April 2013 by Ferring Pharmaceuticals
Sponsor:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01748591
First received: November 9, 2012
Last updated: April 17, 2013
Last verified: April 2013
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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 |
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
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 17, 2013 |
| Health Authority: | Czech Republic: State Institute for Drug Control |
ClinicalTrials.gov processed this record on June 17, 2013