Bowel CleanlinessNCT01748591
Monitoring of Safety and Tolerance of PICOPREP in Clinical Practice
An observational study of Bowel Cleanliness, run by Ferring Pharmaceuticals at 22 sites in Czechia.
Trial summary
A Confirmation of Safety, Tolerance and Efficacy of PICOPREP in Clinical Practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Cleanliness
- Type of treatment
- Pill or oral medicine
- How many people
- 3,324 participants
- Where
- 22 sitesCzechia
- Study dates
- May 2012to Feb 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients eligible for endoscopic examination or surgery
Who may be able to join
- Patients eligible for treatment with PICOPREP® for bowel cleansing prior to endoscopic examination or surgery
Who cannot join
- Patients in which prescription of PICOPREP® is contraindicated
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Czechia22 sites
Nemocnice Rudolfa a Stefanie
Benešov
Nemocnice Blansko
Blansko
Nemocnice Břeclav
Břeclav
Soukrmá ambulance
Česká Lípa
Děčínská nemocnice
Děčín
Nemocnice Havlíčkův Brod
Havlíčkův Brod
Fakultní nemocnice Hradec Králové
Hradec Králové
Nemocnice Jablonec
Jablonec nad Nisou
Nemocnice Jihlava
Jihlava
Privátní GE
Jihlava
FN Olomouc
Olomouc
FN Bulovka
Prague
Privátní GE Praha 4
Prague
Sanatorium Sv.Anny
Prague
Thomayerova nemocnice
Prague
Všeobecná fakutlní nemocnice
Prague
Nemocnice Příbram
Příbram
Lužická nemocnice
Rumburk
Nemocnice Tábor
Tábor
Nemocnice Teplice
Teplice
Ústecká poliklinika
Ústí nad Labem
Nemocnice Znojmo
Znojmo
About this study
Official title: A Study of PICOPREP in Patients Needing to Clean the Bowel Prior to X-ray Examination, Endoscopy or Surgery
A Confirmation of Safety, Tolerance and Efficacy of PICOPREP in Clinical Practice.
- Conditions
- Bowel Cleanliness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PICOPREP treatment | PICOPREP powder for oral solution according to standard clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Frequency of Adverse Events
Measured: 2 days
The Severity of Adverse Events
Measured: 2 days
Secondary outcomes (1)
Treatment efficacy measured by assessment of the quality of colon cleaning
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startMay 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: Terminated due to problems enrolling adequate number of patients.
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
- 3,324 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
- NCT01748591
- Sponsor's protocol ID
- 000062
- Status last verified
- Dec 2015
- First submitted
- 9 Nov 2012
- Last updated
- 22 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of PICOPREP in Patients Needing to Clean the Bowel Prior to X-ray Examination, Endoscopy or Surgery
- ClinicalTrials.gov ID
- NCT01748591
- Acronym / sponsor ID
- 000062
- Conditions
- Bowel Cleanliness
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated due to problems enrolling adequate number of patients.
- Enrolment
- 3,324 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 12 Dec 2012 (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.
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 treatment | – | –PICOPREP powder for oral solution according to standard clinical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients eligible for endoscopic examination or surgery
Key inclusion criteria (1 listed)
- Patients eligible for treatment with PICOPREP® for bowel cleansing prior to endoscopic examination 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.
Primary outcome
The Frequency of Adverse Events
Time frame: 2 days
The Severity of Adverse Events
Time frame: 2 days
1 secondary outcome
Treatment efficacy measured by assessment of the quality of colon cleaning
Time frame: 2 days
Results and safety
The study was stopped early (reason given: Terminated due to problems enrolling adequate number of patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2015.
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Study Comparing the Quality of Colon Cleanliness With Prepackaged LRD (Low-residue Diet) vs. Guided (POG).
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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
22 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 22 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: stopped early, as of the sponsor's last update on 22 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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 was stopped early (reason given: Terminated due to problems enrolling adequate number of patients.). Results are not available in the source record.
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?
The Frequency of Adverse Events (time frame: 2 days). The study lists 2 primary outcomes in all. 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 22 Dec 2015.