A Study of PICOPREP in Patients Needed to Clean the Bowel Prior to X-ray Examination, Endoscopy or Surgery.
This study has been completed.
Sponsor:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01292109
First received: February 8, 2011
Last updated: February 8, 2012
Last verified: February 2012
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Purpose
The study serves as a confirmation of safety, tolerance and efficacy of PICOPREP in clinical practice.
| Condition | Intervention |
|---|---|
|
Bowel Cleanliness |
Drug: sodium picosulphate |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Compliance and Efficacy in the Use of PICOPREP for Bowel Cleansing |
Resource links provided by NLM:
Further study details as provided by Ferring Pharmaceuticals:
Primary Outcome Measures:
- Documentation of use PICOPREP in everyday practice [ Time Frame: Day 0 - 2 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Participant satisfaction and compliance after bowel cleansing [ Time Frame: Days 0-2 ] [ Designated as safety issue: No ]
- Participants with adverse events reported by frequency and severity [ Time Frame: Days 1-2 ] [ Designated as safety issue: Yes ]
| Enrollment: | 252 |
| Study Start Date: | December 2010 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| PICOPREP® |
Drug: sodium picosulphate
Sodium picosulphate (PICOPREP®) taken by participant prior to X-ray examination, endoscopy or surgery.
Other Name: PICOPREP®
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients about to undergo X-ray examination, endoscopy or surgery.
Criteria
Inclusion Criteria:
- Patients receiving PICOPREP® for bowel evacuation prior to endoscopy 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: NCT01292109
Locations
| Czech Republic | |
| University Hospital | |
| Ostrava - Poruba, Czech Republic | |
| University Hospital | |
| Pilsen, Czech Republic | |
| Iscare - Prague 7 | |
| Prague 7, 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: | NCT01292109 History of Changes |
| Other Study ID Numbers: | FE999169 CS03 |
| Study First Received: | February 8, 2011 |
| Last Updated: | February 8, 2012 |
| Health Authority: | Czech Republic: State Institute for Drug Control |
Keywords provided by Ferring Pharmaceuticals:
|
endoscopy colonoscopy preparation for surgery |
Additional relevant MeSH terms:
|
Picosulfate sodium Cathartics Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013