IBDNCT04457934
Effectiveness of PLENVU in the General Screening Population and Patients With IBD
An observational study of IBD and Healthy, run by Johannes Gutenberg University Mainz at 3 sites in Germany.
Trial summary
Patients presenting for endoscopic surveillance of IBD or colorectal screening colonoscopy at one of the participating centers will be asked to participate in the present study after careful evaluation of inclusion and exclusion criteria. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- What is being tested?
- Plenvu
- How many people
- 290 participants
- Where
- 3 sitesGermany
- Study dates
- Sep 2020to Aug 2021
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Screening colonoscopy; IBD; age group 18-75 years
Who may be able to join
- • Suspicion or history of IBD
- Screening colonoscopy
- Indication for colonoscopy
- Age 18-75 years
- Written informed consent
Who cannot join
- • Pregnancy or lactating
- Lower gastrointestinal bleeding with hemodynamic instability
- Bowel obstruction
- ASA >3
- Not sufficiently corrected anticoagulation disorders
- Plenvu must not be taken:
Show all 23Show fewer
- if you are allergic (hypersensitive) to the active ingredients or any of the other ingredients of this medicine;
- if you have a blockage (obstruction) in the digestive tract.
- if you have a breakthrough (perforation) in the wall of the digestive tract;
- if you suffer from intestinal obstruction (Ileus);
- if you suffer from a disturbance of gastric emptying (e.g. gastroparesis, gastric retention);
- if you suffer from phenylketonuria. Phenylketonuria is a congenital metabolic disease in which phenylalanine cannot be processed by your body. Plenvu contains aspartame as a source of phenylalanine;
- if you suffer from glucose-6-phosphate dehydrogenase deficiency;
- if you suffer from acute colon enlargement (toxic megacolon).
- Warnings and precautions
- o You should tell your doctor about the following circumstances before taking Plenvu:
- if you have heart problems and/or arrhythmias;
- if you have kidney problems and/or suffer from dehydration;
- if you have stomach or intestinal problems, including intestinal inflammation;
- if you have difficulty or discomfort when swallowing liquids;
- if you have high or low levels of electrolyte (e.g. sodium, potassium);
- if you have other diseases (e.g. convulsions).
- Pregnancy and lactation o There are no data on the use of Plenvu during pregnancy or lactation and is therefore not recommended.
Trial locations and contacts
3 sites in 1 country.
Germany3 sites, 3 recruiting
- Not yet recruiting
Dr. Helmut Neumann
Bad Salzuflen, Northrine-Westfalia, 32105
Helmut Neumann, Dr. med., +495222 ext. 369836
- Not yet recruiting
Dr. Horst Hohn
Koblenz, Rhenanie-Palatinate, 56068
Horst Hohn, Dr. med., +49261 ext. 18553, praxis@dr-hohn.de
- Recruiting
University Hospital Mainz
Mainz
Prof. Helmut Neumann
About this study
Patients presenting for endoscopic surveillance of IBD or colorectal screening colonoscopy at one of the participating centers will be asked to participate in the present study after careful evaluation of inclusion and exclusion criteria. The aim is that the final study population will comprise of 50% IBD patients and 50% colorectal cancer screening patients. Before inclusion, all patients have to sign the written informed consent. All participating patients will receive PLENVU, a well-known and approved bowel preparation agent. Bowel preparation is performed following the general recommendations of use. Following the bowel preparation, patients are asked if they have well tolerated the preparation, if they already had a colonoscopy in the past with another bowel preparation agent and if they would prefer PLENVU or another bowel preparation for their next endoscopy examination. Endoscopy is performed in standard way and effectiveness of the bowel preparation is specifically highlighted by the physician on the documentation report. Finally, data is analyzed regarding effectiveness of PLENVU for bowel preparation and patient satisfaction.
Read the detailed description
PLENVU is effective for bowel preparation and the efficacy and safety of PLENVU has been investigated in randomized controlled trials in patients undergoing gut cleansing prior to colonoscopy. Data on the specific screening population and for patients suffering from IBD however is limited to date. The aim of the current study is to fill this gap and to provide data of the effectiveness of PLENVU for the specific patients groups in order to provide specific recommendations for an adequate bowel preparation in those groups.
In general, bowel-preparation in IBD patients is often more challenging. This might be due to the chronic disease burden but also according to compliance factors of individual patients. Of note, an adequate bowel-preparation is of paramount importance in IBD in order to detect subtle neoplasia and to perform chromoendoscopy, which is still recommended by the updated ESGE guideline.
It is anticipated, that PLENVU will help IBD patients to achieve a better bowel preparation, thereby yielding in more effective screening colonoscopies and higher acceptance rates of patients for surveillance colonoscopies. In order to show that no significant differences are seen in the included IBD cohort compared to the general screening population (bias risk), the investigators aim to also include patients from the normal screening population.
- Being tested
- Plenvu
- Keywords
- endoscopy, preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlenvuDrug
All patients in both Groups will drink will drink 1 Liter of Plenvu and 1 Liter of water or tea in preparation for endoscopy according to endoscopy guidelines
| Study group | Role | What they receive |
|---|---|---|
| IBD patients | Patients with IBD will undergo preparation for Standard endoscopy with PLENVU, since it is considered to be less affecting for patients. IBD patients have to undergo endoscopy often and mostly suffer from non-efficient preparation.
Patients will drink 1 Liter of Plenvu and 1 Liter of water or tea in preparation for endoscopy and will follow the Guidelines for preparation of endoscopy.
The only Change from Standard care is that patients will receive Plenvu instead of Movicol. Receives: Drug: Plenvu | |
| Screening patients | Screening patients will undergo Standard endoscopy to prevent colon Cancer. Patients will drink 1 Liter of Plenvu and 1 Liter of water or tea in preparation for endoscopy and nd will follow the Guidelines for preparation of endoscopy.
The only Change from Standard care is that patients will receive Plenvu instead of Movicol. Receives: Drug: Plenvu |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Bowel Preparation Standard (BBPS)
Bowel preparation according to international Standard (1 is bad, 9 is good), how many BBPs with 9 can be achieved?
Measured: 1 week
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
How good will patients tolerate endoscopy and preparation
Measured: 1 day
Number of patients with adverse events
What Kind of adverse Events can happen during this study
Measured: up to 1 week
Secondary outcomes (4)
Number of patients who are willing to accept repeated examination (surveillance);
How many patients will come back for another endoscopy
Measured: up to 1 month
Adenoma and Polyp Detection Rate (ADR and PDR)
How many adenomas and polyps are detected during endoscopy
Measured: 1 day
cecal intubation rate
how many endoscopies will reach the ceacum
Measured: 1 day
procedure time
how Long will endoscopy take
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study startSep 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBDStudies 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
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Helmut Neumann, Johannes Gutenberg University Mainz
- Investigators
- Helmut Neumann, Prof. Dr., Principal investigator, University Medical Center Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457934
- Sponsor's protocol ID
- 001
- Other IDs
- 125
- Status last verified
- Sep 2020
- First submitted
- 15 Jun 2020
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: * Preliminary data 2020 for: DDW 2021 (Deadline Dec. 1st), preliminary data will be available for Norgine for DGVS (Germany) and APDW (Malaysia). * Final data: Submission 2021 for DDW, ESGE Days, UEGW, DGVS, APDW * Final manuscript: Am J Gastro -\> Journal Crohn's Colitis -\> Endoscopy -\> Gastrointest Endos
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of PLENVU in the General Screening Population and Patients With IBD
- ClinicalTrials.gov ID
- NCT04457934
- Acronym / sponsor ID
- 001
- Keywords
- endoscopy, preparation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 7 Jul 2020 (actual)
- 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.
Patients presenting for endoscopic surveillance of IBD or colorectal screening colonoscopy at one of the participating centers will be asked to participate in the present study after careful evaluation of inclusion and exclusion criteria. The aim is that the final study population will comprise of 50% IBD patients and 50% colorectal cancer screening patients. Before inclusion, all patients have to sign the written informed consent. All participating patients will receive PLENVU, a well-known and approved bowel preparation agent. Bowel preparation is performed following the general recommendations of use. Following the bowel preparation, patients are asked if they have well tolerated the preparation, if they already had a colonoscopy in the past with another bowel preparation agent and if they would prefer PLENVU or another bowel preparation for their next endoscopy examination. Endoscopy is performed in standard way and effectiveness of the bowel preparation is specifically highlighted by the physician on the documentation report. Finally, data is analyzed regarding effectiveness of PLENVU for bowel preparation and patient satisfaction.
Detailed description
PLENVU is effective for bowel preparation and the efficacy and safety of PLENVU has been investigated in randomized controlled trials in patients undergoing gut cleansing prior to colonoscopy. Data on the specific screening population and for patients suffering from IBD however is limited to date. The aim of the current study is to fill this gap and to provide data of the effectiveness of PLENVU for the specific patients groups in order to provide specific recommendations for an adequate bowel preparation in those groups.
In general, bowel-preparation in IBD patients is often more challenging. This might be due to the chronic disease burden but also according to compliance factors of individual patients. Of note, an adequate bowel-preparation is of paramount importance in IBD in order to detect subtle neoplasia and to perform chromoendoscopy, which is still recommended by the updated ESGE guideline.
It is anticipated, that PLENVU will help IBD patients to achieve a better bowel preparation, thereby yielding in more effective screening colonoscopies and higher acceptance rates of patients for surveillance colonoscopies. In order to show that no significant differences are seen in the included IBD cohort compared to the general screening population (bias risk), the investigators aim to also include patients from the normal screening population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBD patients | – | Drug: PlenvuPatients with IBD will undergo preparation for Standard endoscopy with PLENVU, since it is considered to be less affecting for patients. IBD patients have to undergo endoscopy often and mostly suffer from non-efficient preparation. Patients will drink 1 Liter of Plenvu and 1 Liter of water or tea in preparation for endoscopy and will follow the Guidelines for preparation of endoscopy. The only Change from Standard care is that patients will receive Plenvu instead of Movicol. |
| Screening patients | – | Drug: PlenvuScreening patients will undergo Standard endoscopy to prevent colon Cancer. Patients will drink 1 Liter of Plenvu and 1 Liter of water or tea in preparation for endoscopy and nd will follow the Guidelines for preparation of endoscopy. The only Change from Standard care is that patients will receive Plenvu instead of Movicol. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Screening colonoscopy; IBD; age group 18-75 years
Key inclusion criteria (5 listed)
- • Suspicion or history of IBD
Key exclusion criteria (23 listed)
- • Pregnancy or lactating
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 |
|---|---|---|
| PlenvuAll patients in both Groups will drink will drink 1 Liter of Plenvu and 1 Liter of water or tea in preparation for endoscopy according to endoscopy guidelines | Drug | IBD patients, Screening patients |
Primary outcome
Boston Bowel Preparation Standard (BBPS)
Time frame: 1 week
Bowel preparation according to international Standard (1 is bad, 9 is good), how many BBPs with 9 can be achieved?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 1 day
How good will patients tolerate endoscopy and preparation
Number of patients with adverse events
Time frame: up to 1 week
What Kind of adverse Events can happen during this study
4 secondary outcomes
Number of patients who are willing to accept repeated examination (surveillance);
Time frame: up to 1 month
Adenoma and Polyp Detection Rate (ADR and PDR)
Time frame: 1 day
cecal intubation rate
Time frame: 1 day
procedure time
Time frame: 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- Individual participant dataSharing planned: Yes. * Preliminary data 2020 for: DDW 2021 (Deadline Dec. 1st), preliminary data will be available for Norgine for DGVS (Germany) and APDW (Malaysia). * Final data: Submission 2021 for DDW, ESGE Days, UEGW, DGVS, APDW * Final manuscript: Am J Gastro -> Journal Crohn's Colitis -> Endoscopy -> Gastrointest Endos
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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.
Helmut Neumann, Prof. Dr. principal investigator
University Medical Center Mainz
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 IBD and Healthy, run by Johannes Gutenberg University Mainz at 3 sites in Germany.
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 5 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 7 Sep 2020. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helmut Neumann, Prof. (+491786651595, helmut.neumann@unimedizin-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Bowel Preparation Standard (BBPS) (time frame: 1 week). The study lists 3 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 7 Sep 2020.