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

Официальное название

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

Обзор

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®.

Подробное описание

Not provided

Вмешательства

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

Первичные конечные точки

• Proportion of subjects with adequate bowel cleansing defined by the Boston Bowel Preparation Scale (BBPS) total score [Срок оценки: During colonoscopy (visit4), maximum 28 days after signing the informed consent form)]

Вторичные конечные точки (4)

• Adenoma detection rate [Срок оценки: During colonoscopy (visit4), maximum 28 days after signing the informed consent form)]
• Caecal intubation rate [Срок оценки: During colonoscopy (visit4), maximum 28 days after signing the informed consent form)]
• Proportion of subjects undergoing colonoscopy who have to repeat the procedure [Срок оценки: During colonoscopy (visit4), maximum 28 days after signing the informed consent form)]
• Proportion of subjects undergoing colonoscopy with presence of colonic bubbles [Срок оценки: During colonoscopy (visit4), maximum 28 days after signing the informed consent form)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Диагностика

Центры проведения

Италия · 10 центров

• Azienda Unita Sanitaria Locale Di Modena - Ospedale Ramazzini di Carpi — Carpi
• Centro Di Riferimento Oncologico Di Aviano — Aviano
• IRCCS Ospedale Sacro Cuore Don Calabria — Negrar
• Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Caratte — Bologna
• Fondazione Poliambulanza — Brescia
• Congregazione Delle Suore Infermiere Dell'Addolorata - Ospedale Valduce — Como
• Fondazione IRCCS Cà Granda Ospedale Policlinico — Milan
• Istituto Europeo di Oncologia — Milan
• … и ещё 2 центра

Бельгия · 3 центра

• Hopital Erasme — Anderlecht
• Katholieke Universiteit te Leuven — Leuven
• Algemeen Ziekenhuis Damiaan Oostende — Ostend

Польша · 3 центра

• H-T.Centrum Medyczne Sp. z o.o. sp.k. — Tychy
• Klinika Reuma Park Sp. z o.o. S.K. — Warsaw
• Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy — Warsaw

Испания · 1 центр

• Hospital Clinic De Barcelona — Barcelona

Швеция · 1 центр

• Region Oerebro Laen — Örebro

Идентификаторы

NCT: NCT07465705 · Mannitol_01-2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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