Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Phase 3

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

NCT07465705 · tracked via the Priya Life Science Italy tracker
Sponsor
NTC srl
Phase
Phase 3
Started
2025-09-02
Last updated
2026-03-13

Condition(s) studied

Elective Colonoscopy

Investigational drug(s) / intervention(s)

100g of Mannitol →1L PEG-Asc

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

1L PEG-Asc: 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 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®.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Ability of subject to consent and provide signed written informed consent. 2. Age ≥ 18 years. 3. Males and females scheduled for elective colonoscopy performed according to ESGE guidelines. 4. Subjects willing and able to complete the entire study and to comply with instructions. Exclusion Criteria: 1. 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). 2. 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. 3. Severe renal failure: eGFR \< 30 ml/min/1.73 m2 estimated by simplified MDRD equation. 4. Severe heart failure: New York Heart Association (NYHA) Class III-IV. 5. Severe anaemia (Hb ≤ 8 g/dl). 6. Chronic liver disease Child-Pugh class B or C. 7. Electrolyte disturbances (baseline values of Na2+, Cl-, K+ out of normal ranges). 8. Clinically significant alterations of baseline haemato-chemical parameters. 9. Recent (\< 6 months) symptomatic acute ischemic heart disease. 10. 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. 11. History of paralysis of the gut (ileus). 12. History of disorders of gastric emptying (e.g. gastroparesis, gastric retention, etc.). 13. History of phenylketonuria (due to presence of aspartame). 14. History of glucose-6-phosphate dehydrogenase deficiency (due to presence of ascorbate). 15. History of toxic megacolon. 16. 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. 17. Suspected bowel obstruction or perforation. 18. Indication for partial colonoscopy. 19. Subjects who received an investigational drug or therapy within 5 half-lives of the first visit. 20. Hypersensitivity to the active ingredients or to any of the excipients of the study drugs. 21. Underwater colonoscopy instead of standard gas insufflation.

Primary outcome measure(s)

  • Proportion of subjects with adequate bowel cleansing defined by the Boston Bowel Preparation Scale (BBPS) total score — 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.

Trial sites (18)

FacilityCityRegionStatus
Hopital Erasme Anderlecht Belgium Recruiting
Katholieke Universiteit te Leuven Leuven Belgium Recruiting
Algemeen Ziekenhuis Damiaan Oostende Ostend Belgium Recruiting
Azienda Unita Sanitaria Locale Di Modena - Ospedale Ramazzini di Carpi Carpi Modena Recruiting
Centro Di Riferimento Oncologico Di Aviano Aviano Pordenone Recruiting
IRCCS Ospedale Sacro Cuore Don Calabria Negrar Verona Recruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Bologna Italy Recruiting
Fondazione Poliambulanza Brescia Italy Recruiting
Congregazione Delle Suore Infermiere Dell'Addolorata - Ospedale Valduce Como Italy Recruiting
Fondazione IRCCS Cà Granda Ospedale Policlinico Milan Italy Recruiting
Istituto Europeo di Oncologia Milan Italy Recruiting
Policlinico Universitario A. Gemelli Roma Italy Recruiting
Azienda Provinciale Per I Servizi Sanitari Trento Italy Recruiting
H-T.Centrum Medyczne Sp. z o.o. sp.k. Tychy Poland Recruiting
Klinika Reuma Park Sp. z o.o. S.K. Warsaw Poland Active Not Recruiting
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Warsaw Poland Recruiting
Hospital Clinic De Barcelona Barcelona Spain Recruiting
Region Oerebro Laen Örebro Sweden Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07465705 on ClinicalTrials.gov ↗ ← All trials in Italy