Clinical Trial on Bowel Preparation Comparing Mannitol 100g to Plenvu Both in a Same Day Regimen (CLEARWAY)

NCT07465705 | Recruiting Phase 3

• 1 other identifier: Mannitol_01-2024
• Study Type: interventional
• Target: 412
• Locations: 5 countries
• Sites: 18

Brief 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®.

Conditions

Elective Colonoscopy

Keywords

Colonoscopy preparation; Bowel cleansing; Mannitol

Outcome Measures

Primary Outcomes (1)

• 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.

  During colonoscopy (visit4), maximum 28 days after signing the informed consent form)

Secondary Outcomes (4)

• Adenoma detection rate

  During colonoscopy (visit4), maximum 28 days after signing the informed consent form)

• Caecal intubation rate

  During colonoscopy (visit4), maximum 28 days after signing the informed consent form)

• Proportion of subjects undergoing colonoscopy who have to repeat the procedure

  During colonoscopy (visit4), maximum 28 days after signing the informed consent form)

• Proportion of subjects undergoing colonoscopy with presence of colonic bubbles

  During colonoscopy (visit4), maximum 28 days after signing the informed consent form)

Other Outcomes (14)

• Exploratory Efficacy

  During colonoscopy (visit4), maximum 28 days after signing the informed consent form)

• Adherence

  During colonoscopy (visit4), maximum 28 days after signing the informed consent form, after completing the preparation but before colonoscopy

• Ease of use

  During colonoscopy (visit4), maximum 28 days after signing the informed consent form, after completing the preparation but before colonoscopy

Study Arms (2)

Test arm

EXPERIMENTAL

One day single dose preparation same day of colonoscopy

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

Drug: 1L PEG-Asc

Interventions

100g of Mannitol DRUG

Participants should self administer the preparation within 45 minutes, dissolving 100g of powder in 1L of water

Test arm

1L PEG-Asc DRUG

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.

1L PEG-Asc

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• NTC srl: lead

Study Sites (18)

Hopital Erasme

Anderlecht, 1070, Belgium

RECRUITING

Katholieke Universiteit te Leuven

Leuven, 3000, Belgium

RECRUITING

Algemeen Ziekenhuis Damiaan Oostende

Ostend, 8400, Belgium

RECRUITING

Azienda Unita Sanitaria Locale Di Modena - Ospedale Ramazzini di Carpi

Carpi, Modena, 41012, Italy

RECRUITING

Centro Di Riferimento Oncologico Di Aviano

Aviano, Pordenone, 33081, Italy

RECRUITING

IRCCS Ospedale Sacro Cuore Don Calabria

Negrar, Verona, 37024, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico

Bologna, 40138, Italy

RECRUITING

Fondazione Poliambulanza

Brescia, 25124, Italy

RECRUITING

Congregazione Delle Suore Infermiere Dell'Addolorata - Ospedale Valduce

Como, 22100, Italy

RECRUITING

Fondazione IRCCS Cà Granda Ospedale Policlinico

Milan, 20122, Italy

RECRUITING

Istituto Europeo di Oncologia

Milan, 20141, Italy

RECRUITING

Policlinico Universitario A. Gemelli

Roma, 00168, Italy

RECRUITING

Azienda Provinciale Per I Servizi Sanitari

Trento, 38122, Italy

RECRUITING

H-T.Centrum Medyczne Sp. z o.o. sp.k.

Tychy, 43-100, Poland

RECRUITING

Klinika Reuma Park Sp. z o.o. S.K.

Warsaw, 02-665, Poland

ACTIVE NOT RECRUITING

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Warsaw, 02-781, Poland

RECRUITING

Hospital Clinic De Barcelona

Barcelona, 08036, Spain

RECRUITING

Region Oerebro Laen

Örebro, 701 85, Sweden

RECRUITING

MeSH Terms

Interventions

Mannitol

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Cristiano Spada, Prof.

  Policlinico Universitario A. Gemelli

  STUDY CHAIR

Central Study Contacts

Alessandro Colombo

CONTACT

+393512044335; alessandro.colombo@ntcpharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized 1:1, parallel-group, endoscopist-blinded

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 12, 2026
• Study Start: September 2, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

BE (3); PL (3); IT (10); ES (1); SE (1)