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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®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test arm | Experimental | One day single dose preparation same day of colonoscopy |
|
| 1L PEG-Asc | Active Comparator | Two liters of overall preparation, taken according to split-dose regimen the same day of colonoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 100g of Mannitol | Drug | Participants should self administer the preparation within 45 minutes, dissolving 100g of powder in 1L of water |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma detection rate | Adenoma detection rate, defined as the proportion of subjects ≥ 50 years old undergoing colonoscopy who have at least one lesion detected. | During colonoscopy (visit4), maximum 28 days after signing the informed consent form) |
| Caecal intubation rate |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Efficacy | Number, appearance, size, location, and histological examination of neoplastic and inflammatory colorectal lesions. | During colonoscopy (visit4), maximum 28 days after signing the informed consent form) |
| Adherence |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alessandro Colombo | Contact | +393512044335 | alessandro.colombo@ntcpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Cristiano Spada, Prof. | Policlinico Universitario A. Gemelli | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Erasme | Recruiting | Anderlecht | 1070 | Belgium |
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Randomized 1:1, parallel-group, endoscopist-blinded
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| 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. |
|
Caecal intubation rate, defined as the proportion of subjects undergoing colonoscopy with ileocecal junction appendiceal orifice visible to the endoscopist. |
| 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. | 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). | During colonoscopy (visit4), maximum 28 days after signing the informed consent form) |
Adherence: study drug completely taken, partially taken, not taken.
| During colonoscopy (visit4), maximum 28 days after signing the informed consent form, after completing the preparation but before colonoscopy |
| Ease of use | Ease of use: numeric rating scale (NRS) (0 = very difficult to 10 = very easy). | During colonoscopy (visit4), maximum 28 days after signing the informed consent form, after completing the preparation but before colonoscopy |
| Taste | Taste: NRS (0 = terrible to 10 = very good). | During colonoscopy (visit4), maximum 28 days after signing the informed consent form, after completing the preparation but before colonoscopy |
| Willingness to reuse the preparation | Willingness to reuse the preparation (yes/no). | During colonoscopy (visit4), maximum 28 days after signing the informed consent form, after completing the preparation but before colonoscopy |
| Satisfaction with bowel preparation compared to cleansing agent used for previous colonoscopy. | Satisfaction with bowel preparation compared to cleansing agent used for previous colonoscopy. | During colonoscopy (visit4), maximum 28 days after signing the informed consent form, after completing the preparation but before colonoscopy |
| Incidence of adverse events | Incidence of adverse events starting from the beginning of study drug administration. | From signature of the informed consent form up to and including V5, maximum 29 days after signing the informed consent form |
| Incidence of drug-related adverse events | Incidence of drug-related adverse events starting from the beginning of study drug self-administration | From signature of the informed consent form up to and including V5, maximum 29 days after signing the informed consent form |
| Proportion of subjects with clinically significant change from baseline of haematological and chemical parameters | Proportion of subjects with clinically significant change from baseline of haematological and chemical parameters 4 hours and 8 hours after completion of study drug self-administration, where clinically significant means that in the Investigator's opinion the change needs an additional control or a medical intervention. | At visit 2 (maximum 21 days after signing the informed consent form) and V4 (maximum 28 days after signing the informed consent form) |
| Proportion of subjects with clinically significant change from baseline of heart rate, systolic and diastolic blood | Proportion of subjects with clinically significant change from baseline of heart rate, systolic and diastolic blood pressure measured from the beginning of study drug self-administration to the end of study, as well as clinically significant change of oxygen saturation during colonoscopy, where clinically significant means that in the Investigator's opinion the change needs an additional control or a medical intervention. | At visit 2 (maximum 21 days after signing the informed consent form) and V4 (maximum 28 days after signing the informed consent form) |
| PK sub-study: Cmax | Maximum Peak Plasma Concentration observed concentration (Cmax). | During colonoscopy (visit4), maximum 28 days after signing the informed consent form |
| PK sub-study: tmax | Time to maximum observed concentration (tmax). | During colonoscopy (visit4), maximum 28 days after signing the informed consent form |
| PK sub-study: AUC0-t or AUClast | Area under concentration-time curve, from 0 to the last blood sampling time point with measurable concentration (i.e., the last quantifiable timepoint) (AUC0-t or AUClast). | During colonoscopy (visit4), maximum 28 days after signing the informed consent form |
| PK sub-study: t1/2 | Elimination half-life (t1/2). | During colonoscopy (visit4), maximum 28 days after signing the informed consent form |
| Katholieke Universiteit te Leuven | Recruiting | Leuven | 3000 | Belgium |
|
| Algemeen Ziekenhuis Damiaan Oostende | Recruiting | Ostend | 8400 | Belgium |
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| Azienda Unita Sanitaria Locale Di Modena - Ospedale Ramazzini di Carpi | Recruiting | Carpi | Modena | 41012 | Italy |
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| Centro Di Riferimento Oncologico Di Aviano | Recruiting | Aviano | Pordenone | 33081 | Italy |
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| IRCCS Ospedale Sacro Cuore Don Calabria | Recruiting | Negrar | Verona | 37024 | Italy |
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| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico | Recruiting | Bologna | 40138 | Italy |
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| Fondazione Poliambulanza | Recruiting | Brescia | 25124 | Italy |
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| Congregazione Delle Suore Infermiere Dell'Addolorata - Ospedale Valduce | Recruiting | Como | 22100 | Italy |
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| Fondazione IRCCS Cà Granda Ospedale Policlinico | Recruiting | Milan | 20122 | Italy |
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| Istituto Europeo di Oncologia | Recruiting | Milan | 20141 | Italy |
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| Policlinico Universitario A. Gemelli | Recruiting | Roma | 00168 | Italy |
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| Azienda Provinciale Per I Servizi Sanitari | Recruiting | Trento | 38122 | Italy |
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| H-T.Centrum Medyczne Sp. z o.o. sp.k. | Recruiting | Tychy | 43-100 | Poland |
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| Klinika Reuma Park Sp. z o.o. S.K. | Active, not recruiting | Warsaw | 02-665 | Poland |
| Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy | Recruiting | Warsaw | 02-781 | Poland |
|
| Hospital Clinic De Barcelona | Recruiting | Barcelona | 08036 | Spain |
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| Region Oerebro Laen | Recruiting | Örebro | 701 85 | Sweden |
|
| ID | Term |
|---|---|
| D008353 | Mannitol |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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