Bowel CleanlinessNCT01292109
A Study of PICOPREP in Patients Needed to Clean the Bowel Prior to X-ray Examination, Endoscopy or Surgery.
An observational study of Bowel Cleanliness, run by Ferring Pharmaceuticals at 3 sites in Czechia.
Trial summary
The study serves as a confirmation of safety, tolerance and efficacy of PICOPREP in clinical practice. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bowel Cleanliness
- What is being tested?
- sodium picosulphate
- How many people
- 252 participants
- Where
- 3 sitesCzechia
- Study dates
- Dec 2010to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients about to undergo X-ray examination, endoscopy or surgery.
Who may be able to join
- Patients receiving PICOPREP® for bowel evacuation prior to endoscopy or surgery
Who cannot join
- Patients in which prescription of PICOPREP® is contraindicated
Trial locations and contacts
3 sites in 1 country.
Czechia3 sites
University Hospital
Ostrava - Poruba
University Hospital
Pilsen
Iscare - Prague 7
Prague
About this study
Official title: Compliance and Efficacy in the Use of PICOPREP for Bowel Cleansing
The study serves as a confirmation of safety, tolerance and efficacy of PICOPREP in clinical practice.
- Conditions
- Bowel Cleanliness
- Being tested
- sodium picosulphate
- Keywords
- endoscopy, colonoscopy, preparation for surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium picosulphateDrug
Also called PICOPREP®
Sodium picosulphate (PICOPREP®) taken by participant prior to X-ray examination, endoscopy or surgery.
| Study group | Role | What they receive |
|---|---|---|
| PICOPREP® | Not described Receives: Drug: sodium picosulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Documentation of use PICOPREP in everyday practice
Measured: Day 0 - 2
Secondary outcomes (2)
Participant satisfaction and compliance after bowel cleansing
Measured: Days 0-2
Participants with adverse events reported by frequency and severity
Measured: Days 1-2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startDec 2010
- Primary completionSep 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel CleanlinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292109
- Sponsor's protocol ID
- FE999169 CS03
- Status last verified
- Feb 2012
- First submitted
- 8 Feb 2011
- Last updated
- 9 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance and Efficacy in the Use of PICOPREP for Bowel Cleansing
- ClinicalTrials.gov ID
- NCT01292109
- Acronym / sponsor ID
- FE999169 CS03
- Conditions
- Bowel Cleanliness
- Keywords
- endoscopy, colonoscopy, preparation for surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 9 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study serves as a confirmation of safety, tolerance and efficacy of PICOPREP in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PICOPREP® | – | Drug: sodium picosulphate |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients about to undergo X-ray examination, endoscopy or surgery.
Key inclusion criteria (1 listed)
- Patients receiving PICOPREP® for bowel evacuation prior to endoscopy or surgery
Key exclusion criteria (1 listed)
- Patients in which prescription of PICOPREP® is contraindicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sodium picosulphateAlso: PICOPREP®Sodium picosulphate (PICOPREP®) taken by participant prior to X-ray examination, endoscopy or surgery. | Drug | PICOPREP® |
Primary outcome
Documentation of use PICOPREP in everyday practice
Time frame: Day 0 - 2
2 secondary outcomes
Participant satisfaction and compliance after bowel cleansing
Time frame: Days 0-2
Participants with adverse events reported by frequency and severity
Time frame: Days 1-2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2012.
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Study Comparing the Quality of Colon Cleanliness With Prepackaged LRD (Low-residue Diet) vs. Guided (POG).
Colorectal Cancer Prevention, Colorectal Cancer (Diagnosis)
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Development and Validation of an Artificial Intelligence-assisted System for Bowel Cleanliness Assessment Based on Withdrawal Distance Weighting
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Artificial Intelligence (AI) Technology May Help Patients to Understand Bowel Preparation Better Before They go for Colonoscopy.This Study Attempts to Leverage AI Chatbot in Counselling Patients to Improve Bowel Cleanliness, Reduce Anxiety as Well as Increase Procedural Satisfaction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development Support study director
Ferring Pharmaceuticals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bowel Cleanliness, run by Ferring Pharmaceuticals at 3 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Documentation of use PICOPREP in everyday practice (time frame: Day 0 - 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2012.