Colon DiseasePhase 4INTERPRETNCT04708366
Colon Cleansing Efficacy With 1L vs. 2L vs. 4L-PEG for Colonoscopy Among Inpatients
A Phase 4 study testing NER1006, MoviPrep and Macrogol 400 in people with Colon Disease, run by University of Bologna at 1 site in Italy.
Trial summary
An adequate level of bowel preparation before colonoscopy has an extremely relevant impact on lesion detection and procedure success. The inpatient status represents a well-known independent predictor for inadequate colon cleansing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Disease
- What is being tested?
- NER1006, MoviPrep and Macrogol 400
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 846 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2021to 15 May 2022
- Phase
- Phase 4
- 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
Who may be able to join
- Inpatients scheduled for elective colonoscopy
- bowel preparation performed inside the hospital
- ≥18 years old
Who cannot join
- known or suspected ileus
- gastrointestinal obstruction
- gastric retention
- bowel perforation
- toxic colitis, or megacolon
- phenylketonuria
Show all 11Show fewer
- glucose-6-phosphate dehydrogenase deficiency
- active intestinal bleeding
- emergency colonoscopy
- dementia or illness requiring nasogastric tube for bowel prep administration
- refusal to participate or inability to sign the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Colon Cleansing Efficacy With 1L PEG Versus 2L PEG and 4L PEG for Colonoscopy Among Inpatients: A Randomized Controlled Trial
An adequate level of bowel preparation before colonoscopy has an extremely relevant impact on lesion detection and procedure success. The inpatient status represents a well-known independent predictor for inadequate colon cleansing. A recent prospective, multicentre, Italian study among inpatients showed that an adequate colon cleansing was achieved in 60-70% of patients, far below the ideal threshold of 90%. Interestingly, a higher rate of adequate colon cleansing was reported for a very low-volume (1L) polyethylene glycol (PEG)-based preparation when compared to 4L and 2L PEG-based solutions. However, this finding has to be confirmed as the study was not controlled and the PEG-1L group was much smaller than the other two.
Aim of the present multicenter randomized controlled study will be to assess and compare the efficacy and safety of a novel very-low volume (1L) PEG-based preparation vs. standard-of-care low-volume (2L) and high-volume (4L) PEG-based purge, among inpatients who undergo colonoscopy.
Read the detailed description
An adequate level of bowel preparation before colonoscopy has an extremely relevant impact on lesion detection and procedure success. The inpatient status represents a well-known independent predictor for inadequate colon cleansing. A recent prospective, multicentre, Italian study among inpatients showed that an adequate colon cleansing was achieved in 60-70% of patients, far below the ideal threshold of 90%. Such a low efficacy has several negative consequences: first, it leads to repetition of colonoscopy, therefore prolonging patients' in-hospital stay and increasing the risk of adverse events and costs; second, it augments the risk of missing colorectal lesions, negatively affecting patients' management and increasing costs due to the need for adjunctive diagnostic studies.
Current recommendations on bowel preparation among difficult-to-prepare patients are mostly based on expert opinions, the high-volume 4L polyethylene glycol (PEG)-based prep being considered as the gold standard, possibly with further additional solution. On the other hand, compliance to the bowel preparation has been related to an adequate colon cleansing, and it may be argued that inpatients might find it difficult to take high-volume purge. A recent Italian prospective multicentre study among inpatients showed similar rates of adequate bowel preparation between patients who underwent bowel preparation with and without additional solution. Interestingly, a higher rate of adequate colon cleansing was reported for a very low-volume (1L) polyethylene glycol (PEG)-based preparation when compared to 4L and 2L PEG-based solutions. However, this finding has to be confirmed as the study was not controlled and the PEG-1L group was much smaller than the other two.
Aim of the present randomized multicenter controlled study will be to assess and compare the efficacy and safety of a novel very-low volume (1L) PEG-based preparation vs. standard-of-care low-volume (2L) and high-volume (4L) PEG-based purge, among inpatients.
- Conditions
- Colon Disease
- Being tested
- NER1006, MoviPrep, Macrogol 400
- Keywords
- colonoscopy, hospitalized patients, bowel preparation
- Medical subject headings
- Colonic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NER1006Drug
Also called IMP-1
Patients will be randomly assigned (1:1:1) to receive 1L PEG (PLENVU; Norgine, Amsterdam, Netherlands), administered as a 2-day evening/morning split-dosing, or the 2L PEG + ascorbate preparation (2LPEG - MOVIPREP; Norgine), or the 4L PEG (SELG-ESSE; Alfasigma Bologna, Italy), both administered as a 2-day evening/morning split-dosing regimen.
MoviPrepDrug
Also called IMP-2
Patients will be randomly assigned (1:1:1) to receive 1L PEG (PLENVU; Norgine, Amsterdam, Netherlands), administered as a 2-day evening/morning split-dosing, or the 2L PEG + ascorbate preparation (2LPEG - MOVIPREP; Norgine), or the 4L PEG (SELG-ESSE; Alfasigma Bologna, Italy), both administered as a 2-day evening/morning split-dosing regimen.
Macrogol 400Drug
Also called IMP-3
Patients will be randomly assigned (1:1:1) to receive 1L PEG (PLENVU; Norgine, Amsterdam, Netherlands), administered as a 2-day evening/morning split-dosing, or the 2L PEG + ascorbate preparation (2LPEG - MOVIPREP; Norgine), or the 4L PEG (SELG-ESSE; Alfasigma Bologna, Italy), both administered as a 2-day evening/morning split-dosing regimen.
| Study group | Role | What they receive |
|---|---|---|
| 1L PEG | Experimental | Patients will be prepared with 1L-PEG-based bowel preparation. Receives: Drug: NER1006 |
| 2L PEG | Active comparator | Patients will be prepared with 2L-PEG-based bowel preparation. Receives: Drug: MoviPrep |
| 4L PEG | Active comparator | Patients will be prepared with 4L-PEG-based bowel preparation. Receives: Drug: Macrogol 400 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with adequate colon cleansing
Efficacy will be assessed as the percentage of patients with adequate bowel cleansing, as rated according to the Boston Bowel Preparation Scale (BBPS). This scale gives 0-3 points to each of the three colonic segments (i.e. right colon, transverse colon, and left colon); 0 points are assigned for the worst segment cleansing, whereas at least 2 points stand for adequate segment cleansing. Adequate colon cleansing is defined when at least 2 points are reached in each colonic segment.
Measured: During the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start1 Feb 2021 (estimated)
- Primary completion15 Mar 2022 (estimated)
- Study completion15 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon DiseaseStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 846 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenzo Fuccio, University of Bologna
- Investigators
- Lorenzo Fuccio, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708366
- Sponsor's protocol ID
- INTERPRET
- Acronym
- INTERPRET
- Status last verified
- Jan 2021
- First submitted
- 29 Dec 2020
- Last updated
- 13 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Frazzoni L, Cesaro P, Radaelli F, Fabbri C, Guglielmo S, Mussetto A, Manno M, Pugliano CL, Segatta F, Pezzuto E, Raschi E, Facciorusso A, Hassan C, Spada C, Fuccio L; INTERPRET Study Group. Low-Volume Polyethylene Glycol for Bowel Preparation in Hospitalized Adults : A Multicenter Randomized Trial. Ann Intern Med. 2026 Jun;179(6):785-793. doi: 10.7326/ANNALS-25-05005. Epub 2026 May 5.
PubMed 42081822
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colon Cleansing Efficacy With 1L PEG Versus 2L PEG and 4L PEG for Colonoscopy Among Inpatients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04708366
- Acronym / sponsor ID
- INTERPRET / INTERPRET
- Conditions
- Colon Disease
- Keywords
- colonoscopy, hospitalized patients, bowel preparation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 846 participants (estimated)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 15 Mar 2022 (estimated)
- Study completion
- 15 May 2022 (estimated)
- First posted
- 13 Jan 2021 (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.
An adequate level of bowel preparation before colonoscopy has an extremely relevant impact on lesion detection and procedure success. The inpatient status represents a well-known independent predictor for inadequate colon cleansing. A recent prospective, multicentre, Italian study among inpatients showed that an adequate colon cleansing was achieved in 60-70% of patients, far below the ideal threshold of 90%. Interestingly, a higher rate of adequate colon cleansing was reported for a very low-volume (1L) polyethylene glycol (PEG)-based preparation when compared to 4L and 2L PEG-based solutions. However, this finding has to be confirmed as the study was not controlled and the PEG-1L group was much smaller than the other two.
Aim of the present multicenter randomized controlled study will be to assess and compare the efficacy and safety of a novel very-low volume (1L) PEG-based preparation vs. standard-of-care low-volume (2L) and high-volume (4L) PEG-based purge, among inpatients who undergo colonoscopy.
Detailed description
An adequate level of bowel preparation before colonoscopy has an extremely relevant impact on lesion detection and procedure success. The inpatient status represents a well-known independent predictor for inadequate colon cleansing. A recent prospective, multicentre, Italian study among inpatients showed that an adequate colon cleansing was achieved in 60-70% of patients, far below the ideal threshold of 90%. Such a low efficacy has several negative consequences: first, it leads to repetition of colonoscopy, therefore prolonging patients' in-hospital stay and increasing the risk of adverse events and costs; second, it augments the risk of missing colorectal lesions, negatively affecting patients' management and increasing costs due to the need for adjunctive diagnostic studies.
Current recommendations on bowel preparation among difficult-to-prepare patients are mostly based on expert opinions, the high-volume 4L polyethylene glycol (PEG)-based prep being considered as the gold standard, possibly with further additional solution. On the other hand, compliance to the bowel preparation has been related to an adequate colon cleansing, and it may be argued that inpatients might find it difficult to take high-volume purge. A recent Italian prospective multicentre study among inpatients showed similar rates of adequate bowel preparation between patients who underwent bowel preparation with and without additional solution. Interestingly, a higher rate of adequate colon cleansing was reported for a very low-volume (1L) polyethylene glycol (PEG)-based preparation when compared to 4L and 2L PEG-based solutions. However, this finding has to be confirmed as the study was not controlled and the PEG-1L group was much smaller than the other two.
Aim of the present randomized multicenter controlled study will be to assess and compare the efficacy and safety of a novel very-low volume (1L) PEG-based preparation vs. standard-of-care low-volume (2L) and high-volume (4L) PEG-based purge, among inpatients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1L PEG | Experimental | Drug: NER1006Patients will be prepared with 1L-PEG-based bowel preparation. |
| 2L PEG | Active comparator | Drug: MoviPrepPatients will be prepared with 2L-PEG-based bowel preparation. |
| 4L PEG | Active comparator | Drug: Macrogol 400Patients will be prepared with 4L-PEG-based bowel preparation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Inpatients scheduled for elective colonoscopy
- bowel preparation performed inside the hospital
- ≥18 years old
Key exclusion criteria (11 listed)
- known or suspected ileus
- gastrointestinal obstruction
- gastric retention
- bowel perforation
- toxic colitis, or megacolon
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 |
|---|---|---|
| NER1006Also: IMP-1Patients will be randomly assigned (1:1:1) to receive 1L PEG (PLENVU; Norgine, Amsterdam, Netherlands), administered as a 2-day evening/morning split-dosing, or the 2L PEG + ascorbate preparation (2LPEG - MOVIPREP; Norgine), or the 4L PEG (SELG-ESSE; Alfasigma Bologna, Italy), both administered as a 2-day evening/morning split-dosing regimen. | Drug | 1L PEG |
| MoviPrepAlso: IMP-2Patients will be randomly assigned (1:1:1) to receive 1L PEG (PLENVU; Norgine, Amsterdam, Netherlands), administered as a 2-day evening/morning split-dosing, or the 2L PEG + ascorbate preparation (2LPEG - MOVIPREP; Norgine), or the 4L PEG (SELG-ESSE; Alfasigma Bologna, Italy), both administered as a 2-day evening/morning split-dosing regimen. | Drug | 2L PEG |
| Macrogol 400Also: IMP-3Patients will be randomly assigned (1:1:1) to receive 1L PEG (PLENVU; Norgine, Amsterdam, Netherlands), administered as a 2-day evening/morning split-dosing, or the 2L PEG + ascorbate preparation (2LPEG - MOVIPREP; Norgine), or the 4L PEG (SELG-ESSE; Alfasigma Bologna, Italy), both administered as a 2-day evening/morning split-dosing regimen. | Drug | 4L PEG |
Primary outcome
Proportion of patients with adequate colon cleansing
Time frame: During the procedure.
Efficacy will be assessed as the percentage of patients with adequate bowel cleansing, as rated according to the Boston Bowel Preparation Scale (BBPS). This scale gives 0-3 points to each of the three colonic segments (i.e. right colon, transverse colon, and left colon); 0 points are assigned for the worst segment cleansing, whereas at least 2 points stand for adequate segment cleansing. Adequate colon cleansing is defined when at least 2 points are reached in each colonic segment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Derived from this study: PubMed 42081822Frazzoni L, Cesaro P, Radaelli F, Fabbri C, Guglielmo S, Mussetto A, Manno M, Pugliano CL, Segatta F, Pezzuto E, Raschi E, Facciorusso A, Hassan C, Spada C, Fuccio L; INTERPRET Study Group. Low-Volume Polyethylene Glycol for Bowel Preparation in Hospitalized Adults : A Multicenter Randomized Trial. Ann Intern Med. 2026 Jun;179(6):785-793. doi: 10.7326/ANNALS-25-05005. Epub 2026 May 5.
- Individual participant dataSharing planned: No
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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.
Lorenzo Fuccio principal investigator
University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NER1006, MoviPrep and Macrogol 400 in people with Colon Disease, run by University of Bologna at 1 site in Italy.
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 3 inclusion and 11 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 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Lorenzo Fuccio (+39 051 2143338, lorenzofuccio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with adequate colon cleansing (time frame: During the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04708366, which also lists 1 linked publication.
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 13 Jan 2021.