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
| Tracking Information | |||||
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| First Received Date ICMJE | February 8, 2011 | ||||
| Last Updated Date | February 8, 2012 | ||||
| Start Date ICMJE | December 2010 | ||||
| Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Documentation of use PICOPREP in everyday practice [ Time Frame: Day 0 - 2 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01292109 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study of PICOPREP in Patients Needed to Clean the Bowel Prior to X-ray Examination, Endoscopy or Surgery. | ||||
| Official Title ICMJE | Compliance and Efficacy in the Use of PICOPREP for Bowel Cleansing | ||||
| Brief Summary | The study serves as a confirmation of safety, tolerance and efficacy of PICOPREP in clinical practice. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients about to undergo X-ray examination, endoscopy or surgery. |
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| Condition ICMJE | Bowel Cleanliness | ||||
| Intervention ICMJE | Drug: sodium picosulphate
Sodium picosulphate (PICOPREP®) taken by participant prior to X-ray examination, endoscopy or surgery.
Other Name: PICOPREP® |
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| Study Group/Cohort (s) | PICOPREP®
Intervention: Drug: sodium picosulphate |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 252 | ||||
| Completion Date | February 2012 | ||||
| Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Czech Republic | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01292109 | ||||
| Other Study ID Numbers ICMJE | FE999169 CS03 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Ferring Pharmaceuticals | ||||
| Study Sponsor ICMJE | Ferring Pharmaceuticals | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Ferring Pharmaceuticals | ||||
| Verification Date | February 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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