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

RecruitingPhase 3Ages 18 Years - anyAllNTC srl
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In plain words

What the trial is, and whether it could suit you

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®.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • 100g of Mannitol
  • 1L PEG-Asc
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Where

18 sites
Hopital Erasme
Anderlecht, Belgium
Katholieke Universiteit te Leuven
Leuven, Belgium
Algemeen Ziekenhuis Damiaan Oostende
Ostend, Belgium
Azienda Unita Sanitaria Locale Di Modena - Ospedale Ramazzini di Carpi
Carpi, Italy
Centro Di Riferimento Oncologico Di Aviano
Aviano, Italy
IRCCS Ospedale Sacro Cuore Don Calabria
Negrar, Italy
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Bologna, Italy
Fondazione Poliambulanza
Brescia, Italy

…and 10 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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