Elective ColonoscopyPhase 3CLEARWAYNCT07465705
Clinical Trial on Bowel Preparation Comparing Mannitol 100g to Plenvu Both in a Same Day Regimen (CLEARWAY)
A Phase 3 study testing 100g of Mannitol and 1L PEG-Asc in people with Elective Colonoscopy, run by NTC srl at 18 sites in 5 countries.
Trial summary
This is a study to test the non-inferiority of bowel cleansing with 100 g Mannitol against standard Plenvu® same-day dosing regimen. The 50% of the subjects will receive Mannitol, while the remaining part will receive Plenvu®. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elective Colonoscopy
- What is being tested?
- 100g of Mannitol and 1L PEG-Asc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 412 participants
- Where
- 18 sitesin 5 countries
- Study dates
- 2 Sep 2025to 30 Jun 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Ability of subject to consent and provide signed written informed consent.
- Age ≥ 18 years.
- Males and females scheduled for elective colonoscopy performed according to ESGE guidelines.
- Subjects willing and able to complete the entire study and to comply with instructions.
Who cannot join
- Pregnancy or breast feeding. Females of childbearing potential must have a negative pregnancy test at Visit 2 and practice highly effective methods of birth control throughout the study period, according to the CTCG "Recommendations related to contraception and pregnancy testing in clinical trials" v 1.2* (unless postmenopausal or surgically sterile, or whose sole sexual partner had a successful vasectomy).
- Severe acute and chronically active inflammatory bowel disease; subjects in clinical remission (Crohn's Disease Activity Index - CDAI < 150 for Crohn Disease (Best et al. 1976) and Partial Mayo Score ≤ 2 for Ulcerative Colitis (Schroeder et al. 1987)) are allowed.
- Severe renal failure: eGFR < 30 ml/min/1.73 m2 estimated by simplified MDRD equation.
- Severe heart failure: New York Heart Association (NYHA) Class III-IV.
- Severe anaemia (Hb ≤ 8 g/dl).
- Chronic liver disease Child-Pugh class B or C.
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- Electrolyte disturbances (baseline values of Na2+, Cl-, K+ out of normal ranges).
- Clinically significant alterations of baseline haemato-chemical parameters.
- Recent (< 6 months) symptomatic acute ischemic heart disease.
- History of significant gastrointestinal surgeries, including colon resection, sub-total colectomy, abdominoperineal resection, de-functioning colostomy or ileostomy, Hartmann's procedure and other surgeries involving the structure and function of the colon.
- History of paralysis of the gut (ileus).
- History of disorders of gastric emptying (e.g. gastroparesis, gastric retention, etc.).
- History of phenylketonuria (due to presence of aspartame).
- History of glucose-6-phosphate dehydrogenase deficiency (due to presence of ascorbate).
- History of toxic megacolon.
- Use within 24 hours prior to colonoscopy of laxatives, colon motility altering drugs and/or other substances (e.g., simethicone) that could affect bowel cleansing or visibility during colonoscopy.
- Suspected bowel obstruction or perforation.
- Indication for partial colonoscopy.
- Subjects who received an investigational drug or therapy within 5 half-lives of the first visit.
- Hypersensitivity to the active ingredients or to any of the excipients of the study drugs.
- Underwater colonoscopy instead of standard gas insufflation.
Trial locations and contacts
18 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 5 countries
Italy10 sites, 10 recruiting
- Recruiting
Centro Di Riferimento Oncologico Di Aviano
Aviano, Pordenone, 33081
Renato Cannizzaro, Prof.
- Recruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Bologna, 40138
Lorenzo Fuccio, Dr.
- Recruiting
Fondazione Poliambulanza
Brescia, 25124
Paola Cesaro, Dr.
- Recruiting
Azienda Unita Sanitaria Locale Di Modena - Ospedale Ramazzini di Carpi
Carpi, Modena, 41012
Mauro Manno, Dr.
- Recruiting
Congregazione Delle Suore Infermiere Dell'Addolorata - Ospedale Valduce
Como, 22100
Franco Radaelli, Dr.
- Recruiting
Fondazione IRCCS Cà Granda Ospedale Policlinico
Milan, 20122
Gian Eugenio Tontini, Prof.
- Recruiting
Istituto Europeo di Oncologia
Milan, 20141
Giuseppe De Roberto, Dr.
- Recruiting
IRCCS Ospedale Sacro Cuore Don Calabria
Negrar, Verona, 37024
Paolo Bocus, Dr.
- Recruiting
Policlinico Universitario A. Gemelli
Roma, 00168
Cristiano Spada, Prof.
- Recruiting
Azienda Provinciale Per I Servizi Sanitari
Trento, 38122
Armando Gabbrielli, Dr.
Belgium3 sites, 3 recruiting
- Recruiting
Hopital Erasme
Anderlecht, 1070
Arnaud Lemmers, Prof.
- Recruiting
Katholieke Universiteit te Leuven
Leuven, 3000
Raf Bisschops, Prof.
- Recruiting
Algemeen Ziekenhuis Damiaan Oostende
Ostend, 8400
Pieter DeWint, Prof.
Poland3 sites, 2 recruiting
- Recruiting
H-T.Centrum Medyczne Sp. z o.o. sp.k.
Tychy, 43-100
Marcin Romanczyk, Dr.
- Active, not recruiting
Klinika Reuma Park Sp. z o.o. S.K.
Warsaw, 02-665
- Recruiting
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Warsaw, 02-781
Michal Filip Kaminski, Prof.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic De Barcelona
Barcelona, 08036
Maria Pellise Urquiza, Dr.
Sweden1 site, 1 recruiting
- Recruiting
Region Oerebro Laen
Örebro, 701 85
Nills Nyhlin, Prof.
About this study
Official title: A Phase III, International, Multicenter, Randomized, Parallel-group, Endoscopist-blinded Non-inferiority Study of the Efficacy, Safety and Patient Acceptance of Mannitol Versus Plenvu® in Bowel Preparation for Elective Colonoscopy. CLEARWAY
This is a study to test the non-inferiority of bowel cleansing with 100 g Mannitol against standard Plenvu® same-day dosing regimen. The 50% of the subjects will receive Mannitol, while the remaining part will receive Plenvu®.
Read the detailed description
Not provided
- Conditions
- Elective Colonoscopy
- Being tested
- 100g of Mannitol, 1L PEG-Asc
- Keywords
- Colonoscopy preparation, Bowel cleansing, Mannitol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100g of MannitolDrug
Participants should self administer the preparation within 45 minutes, dissolving 100g of powder in 1L of water
1L PEG-AscDrug
Self administration of the same day preparation according to the on lable instruction for use. The first dose consists in dissolving Dose 1 in 500ml of water, followed by another 500ml of water, all within 1 hour. After a 1 hour wait from the end of the first dose, the participant should self administer the Dose 2 consisting in dissolving one sachetA and one sachetB in 500ml of water, followed by another 500ml of water; all within 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Test arm | Experimental | One day single dose preparation same day of colonoscopy Receives: Drug: 100g of Mannitol |
| 1L PEG-Asc | Active comparator | Two liters of overall preparation, taken according to split-dose regimen the same day of colonoscopy Receives: Drug: 1L PEG-Asc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with adequate bowel cleansing defined by the Boston Bowel Preparation Scale (BBPS) total score
Proportion of subjects with adequate bowel cleansing, defined as BBPS total score ≥ 6, with a score for each of the three colon segments (right; transverse, including flexures; and left, including sigmoid and rectum) ≥ 2 after standard washing and air or CO2 insufflation for luminal distension.
Measured: During colonoscopy (visit4), maximum 28 days after signing the informed consent form)
Secondary outcomes (4)
Adenoma detection rate
Adenoma detection rate, defined as the proportion of subjects ≥ 50 years old undergoing colonoscopy who have at least one lesion detected.
Measured: During colonoscopy (visit4), maximum 28 days after signing the informed consent form)
Caecal intubation rate
Caecal intubation rate, defined as the proportion of subjects undergoing colonoscopy with ileocecal junction appendiceal orifice visible to the endoscopist.
Measured: During colonoscopy (visit4), maximum 28 days after signing the informed consent form)
Proportion of subjects undergoing colonoscopy who have to repeat the procedure
Proportion of subjects undergoing colonoscopy who have to repeat the procedure due to inadequate intestinal cleansing to resolve, at the discretion of the endoscopist, the clinical issue underlying the request for colonoscopy.
Measured: During colonoscopy (visit4), maximum 28 days after signing the informed consent form)
Proportion of subjects undergoing colonoscopy with presence of colonic bubbles
Proportion of subjects undergoing colonoscopy with presence of colonic bubbles assessed through the Colon Endoscopic Bubble Scale (CEBuS).
Measured: During colonoscopy (visit4), maximum 28 days after signing the informed consent form)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start2 Sep 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective ColonoscopyStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized 1:1, parallel-group, endoscopist-blinded
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 412 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NTC srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cristiano Spada, Prof., Study chair, Policlinico Universitario A. Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465705
- Sponsor's protocol ID
- Mannitol_01-2024
- Acronym
- CLEARWAY
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, International, Multicenter, Randomized, Parallel-group, Endoscopist-blinded Non-inferiority Study of the Efficacy, Safety and Patient Acceptance of Mannitol Versus Plenvu® in Bowel Preparation for Elective Colonoscopy. CLEARWAY
- ClinicalTrials.gov ID
- NCT07465705
- Acronym / sponsor ID
- CLEARWAY / Mannitol_01-2024
- Conditions
- Elective Colonoscopy
- Keywords
- Colonoscopy preparation, Bowel cleansing, Mannitol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 412 participants (estimated)
- Lead sponsor
- NTC srlIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 12 Mar 2026 (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.
This is a study to test the non-inferiority of bowel cleansing with 100 g Mannitol against standard Plenvu® same-day dosing regimen. The 50% of the subjects will receive Mannitol, while the remaining part will receive Plenvu®.
Detailed description
Not provided
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized 1:1, parallel-group, endoscopist-blinded
| Arm | Type | Receives |
|---|---|---|
| Test arm | Experimental | Drug: 100g of MannitolOne day single dose preparation same day of colonoscopy |
| 1L PEG-Asc | Active comparator | Drug: 1L PEG-AscTwo liters of overall preparation, taken according to split-dose regimen the same day of colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability of subject to consent and provide signed written informed consent.
- Age ≥ 18 years.
- Males and females scheduled for elective colonoscopy performed according to ESGE guidelines.
- Subjects willing and able to complete the entire study and to comply with instructions.
Key exclusion criteria (21 listed)
- Pregnancy or breast feeding. Females of childbearing potential must have a negative pregnancy test at Visit 2 and practice highly effective methods of birth control throughout the study period, according to the CTCG "Recommendations related to contraception and pregnancy testing in clinical trials" v 1.2* (unless postmenopausal or surgically sterile, or whose sole sexual partner had a successful vasectomy).
- Severe acute and chronically active inflammatory bowel disease; subjects in clinical remission (Crohn's Disease Activity Index - CDAI < 150 for Crohn Disease (Best et al. 1976) and Partial Mayo Score ≤ 2 for Ulcerative Colitis (Schroeder et al. 1987)) are allowed.
- Severe renal failure: eGFR < 30 ml/min/1.73 m2 estimated by simplified MDRD equation.
- Severe heart failure: New York Heart Association (NYHA) Class III-IV.
- Severe anaemia (Hb ≤ 8 g/dl).
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 |
|---|---|---|
| 100g of MannitolParticipants should self administer the preparation within 45 minutes, dissolving 100g of powder in 1L of water | Drug | Test arm |
| 1L PEG-AscSelf administration of the same day preparation according to the on lable instruction for use. The first dose consists in dissolving Dose 1 in 500ml of water, followed by another 500ml of water, all within 1 hour. After a 1 hour wait from the end of the first dose, the participant should self administer the Dose 2 consisting in dissolving one sachetA and one sachetB in 500ml of water, followed by another 500ml of water; all within 1 hour. | Drug | 1L PEG-Asc |
Primary outcome
Proportion of subjects with adequate bowel cleansing defined by the Boston Bowel Preparation Scale (BBPS) total score
Time frame: During colonoscopy (visit4), maximum 28 days after signing the informed consent form)
Proportion of subjects with adequate bowel cleansing, defined as BBPS total score ≥ 6, with a score for each of the three colon segments (right; transverse, including flexures; and left, including sigmoid and rectum) ≥ 2 after standard washing and air or CO2 insufflation for luminal distension.
4 secondary outcomes
Adenoma detection rate
Time frame: During colonoscopy (visit4), maximum 28 days after signing the informed consent form)
Caecal intubation rate
Time frame: During colonoscopy (visit4), maximum 28 days after signing the informed consent form)
Proportion of subjects undergoing colonoscopy who have to repeat the procedure
Time frame: During colonoscopy (visit4), maximum 28 days after signing the informed consent form)
Proportion of subjects undergoing colonoscopy with presence of colonic bubbles
Time frame: During colonoscopy (visit4), maximum 28 days after signing the informed consent form)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Cristiano Spada, Prof. study chair
Policlinico Universitario A. Gemelli
18 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 100g of Mannitol and 1L PEG-Asc in people with Elective Colonoscopy, run by NTC srl at 18 sites in 5 countries.
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 4 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Italy, Belgium, Poland, Spain, Sweden. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Colombo (+393512044335, alessandro.colombo@ntcpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with adequate bowel cleansing defined by the Boston Bowel Preparation Scale (BBPS) total score (time frame: During colonoscopy (visit4), maximum 28 days after signing the informed consent form)). 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 13 Mar 2026.