Elective Colonoscopy Clinical Trial
— SATISFACTIONOfficial title:
Efficacy and Safety of mAnniTol in Bowel Preparation: Assessment of Adequacy and Presence of Intestinal levelS of Hydrogen and Methane During Elective Colonoscopy aFter mAnnitol or Standard Split 2-liter Polyethylene Glycol Solution Plus asCorbaTe - a Phase II/III, International, Multicentre, Randomized, Parallel-group, endoscOpist-bliNded, Dose-finding/Non-inferiority Study - SATISFACTION
| Verified date | July 2022 |
| Source | NTC srl |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this dose finding/comparative efficacy study is to first single out the most appropriate dose of mannitol for bowel preparation (phase II) and, subsequently, demonstrate the non-inferiority of the efficacy of single dose mannitol vs standard split 2L PEG ASC (Moviprep®) (phase III) in bowel preparation for colonoscopy .
| Status | Completed |
| Enrollment | 886 |
| Est. completion date | July 16, 2021 |
| Est. primary completion date | July 16, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. Ability of patient to consent and provide signed written informed consent 2. Age = 18 years 3. Males and females scheduled for elective (screening, surveillance or diagnostic) colonoscopy to be prepared and performed according to the European Society of Gastrointestinal Endoscopy (ESGE) Guideline 4. Patients willing and able to complete the entire study and to comply with instructions Exclusion Criteria: 1. Pregnancy or breastfeeding. Females of childbearing potential must have a negative pregnancy test at Visit 2 and must practice one of the following methods of birth control throughout the study period (unless postmenopausal or surgically sterile, or whose sole sexual partner has had a successful vasectomy): oral, implantable, or injectable contraceptives (for a minimum of three months before study entry) in combination with a condom; intrauterine device in combination with a condom; double barrier method (condom and occlusive cap with spermicidal foam/gel/film/cream/suppository). 2. Severe renal failure: glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2 estimated by means of simplified MDRD equation. 3. Severe heart failure: NYHA Class III-IV. 4. Severe anaemia (Hb = 8 g/dl). 5. Severe acute and chronically active Inflammatory Bowel Disease; patients in clinical remission (Crohn's Disease Activity Index - CDAI < 150 for Crohn Disease and Partial Mayo Score = 2 for Ulcerative Colitis) are allowed. 6. Chronic liver disease Child-Pugh class B or C. 7. Electrolyte disturbances (Na, Cl, K, Ca or P out of normal ranges). 8. Recent (< 6 months) symptomatic acute ischemic heart disease. 9. 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. 10. Use of laxatives, colon motility altering drugs and/or other substances (e.g. simethicone) that can affect bowel cleansing or visibility during colonoscopy within 24 hours prior to colonoscopy. 11. Suspected bowel obstruction or perforation. 12. Indication for partial colonoscopy. 13. Patients who have received an investigational drug or therapy within 5 half-lives of the first visit. 14. Patients previously screened for participation in this study. 15. Hypersensitivity to the active ingredients or to any of the excipients of the study drugs. 16. Contraindication to Moviprep® (only for phase III). |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Hospitalier Henri Duffaut | Avignon | |
| France | Hôpital Edouard Herriot | Lyon | |
| France | Hospices civils de Lyon | Lyon | |
| France | Centre Hospitalier Universitaire de Montpellier | Montpellier | |
| Germany | Klinikum der Stadt Ludwigshafen | Ludwigshafen | |
| Germany | Praxis für Gastroenterologie und Fachärztliche Innere Medizin, Im Haus der Gesundheit | Ludwigshafen am Rhein | |
| Germany | Katholisches Klinikum Mainz | Mainz | |
| Germany | Klinikum Worms Medizinische Klinik II | Worms | |
| Italy | Centro di Riferimento Oncologico IRCCS | Aviano | PN |
| Italy | Fondazione Poliambulanza - Istituto Ospedaliero | Brescia | BR |
| Italy | Azienda USL di Modena - Ospedale Ramazzini di Carpi | Carpi | MO |
| Italy | IRCCS "Saverio De Bellis" | Castellana Grotte | BA |
| Italy | Ospedale Valduce | Como | CO |
| Italy | ASST Rhodense - Presidi di Rho e Garbagnate | Garbagnate Milanese | MI |
| Italy | ASSL Carbonia - Presidio Ospedaliero CTO di Iglesias | Iglesias | CI |
| Italy | ASST Grande Ospedale Metropolitano Niguarda | Milano | MI |
| Italy | Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano | Milano | MI |
| Italy | IRCCS Ospedale San Raffaele | Milano | MI |
| Italy | Istituto Europeo di Oncologia | Milano | MI |
| Italy | Ospedale Sacro Cuore | Negrar | VR |
| Italy | Azienda Ospedaliero-Universitaria Maggiore della Carità | Novara | |
| Italy | Azienda Ospedaliero Universitaria Pisana- Ospedale Cisanello | Pisa | PI |
| Italy | Policlinico Universitario A. Gemelli | Roma | RO |
| Italy | IRCCS Policlinico San Donato | San Donato Milanese | MI |
| Italy | Fondazione Casa Sollievo Della Sofferenza | San Giovanni Rotondo | FG |
| Italy | Presidio Ospedaliero Santa Chiara | Trento | TN |
| Italy | ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi | Varese | |
| Russian Federation | Irkutsk State Medical Academy of Postgraduate Education | Irkutsk | |
| Russian Federation | Clinical Hospital of Russian Railways N.A. Semashko | Moscow | |
| Russian Federation | Moscow Clinical Research and Practical Center of the Department of Health | Moscow | |
| Russian Federation | State Central Clinical Hospital A. N. Ryzhykh | Moscow | |
| Russian Federation | Railway Clinical Hospital | Rostov | |
| Russian Federation | Private educational organization of higher education "Medical University "Reaviz" | Samara | |
| Russian Federation | Medical Center of Diagnostics and Prevention | Yaroslavl | |
| Russian Federation | Regional Oncological Clinical Hospital | Yaroslavl |
| Lead Sponsor | Collaborator |
|---|---|
| NTC srl |
France, Germany, Italy, Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Phase II - Dose finding: Patients in safe condition related to potentially critical concentrations of gases (H2/CH4) | Proportion of patients in safe condition for intestinal gases defined as concentration of potentially critical concentrations of gases (H2>4% and CH4 >5%) | During colonoscopy after standard washing and air insufflation for luminal distension at Visit 4 | |
| Other | Phase II - Dose finding: Incidence of adverse events | Incidence of adverse events from the enrollment | Visit 2 (= 7 days before Visit 4), Visit 3 (= 7 days before Visit 4) and Visit 4 (day of colonoscopy) | |
| Other | Phase II - Dose finding: Proportion of patients with clinically significant change of haematological and chemical parameters from baseline | Proportion of patients with change from baseline considered clinically significant by the Investigator of haematological and chemical parameters (CBC, creatinine, BUN, eGFR, ALT, AST, glucose, electrolytes) 4 hours and 8 hours after completion of study drug self-administration. | During visit 4 (day of colonoscopy), 4 hours and 8 hours after completion of study drug self administration | |
| Other | Phase II - Dose finding: Proportion of patients with clinically significant change of vital signs during colonoscopy | Proportion of patients with change of vital signs during colonoscopy considered clinically significant by the Investigator (heart rate and pulse oximetry). | During the colonoscopy at Visit 4 | |
| Other | Phase III - Dose finding:Patients in safe condition related to potentially critical concentration of gases (H2/CH4) | Proportion of patients in safe condition for intestinal gases defined as concentration of potentially critical concentration of gases (H2>4% and CH4 >5%) | During the colonoscopy at Visit 4 | |
| Other | Phase III - Non-inferiority: Incidence of adverse events | Incidence of adverse events from enrollment | Visit 2 (= 7 days before Visit 4), Visit 3 (= 7 days before Visit 4) and Visit 4 (day of colonoscopy) | |
| Other | Phase III - Non-inferiority: Proportion of patients with clinically significant change of haematological and chemical parameters from baseline | Proportion of patients with change from baseline considered clinically significant by the Investigator of haematological and chemical parameters (CBC, creatinine, BUN, eGFR, ALT, AST, glucose, electrolytes) 4 hours and 8 hours after completion of study drug self-administration. | During visit 4 (day of colonoscopy), 4 hours and 8 hours after completion of study drug self-administration | |
| Other | Phase III - Non-inferiority: Proportion of patients with change of vital signs from baseline and during colonoscopy | Proportion of patients with change of vital signs from baseline considered clinically significant by the Investigator (heart rate, systolic and diastolic blood pressure), as well as clinically significant change during colonoscopy of pulse oximetry, systolic and diastolic blood pressure and heart rate. | Visit 4 prior to colonoscopy | |
| Primary | Phase II - Dose finding: Proportion of patients with adequate bowel cleansing | Proportion of patients 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 during colonoscopy after standard washing and air insufflation for luminal distension. | During colonoscopy (Visit 4) | |
| Primary | Phase III - Non-inferiority: Proportion of patients with adequate bowel cleansing | Proportion of patients 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 during colonoscopy after standard washing and air insufflation for luminal distension. | During colonoscopy (Visit 4) | |
| Secondary | Phase II - Dose finding: Caecal intubation rate | The percentage of patients with appendiceal orifice visible to the endoscopist. | During colonoscopy at Visit 4 | |
| Secondary | Phase II - Dose finding: Adherence to bowel preparation | Proportion of patient that completely taken, partially taken or not taken assigned mannitol dose. | During visit 4, 4 hours after the end of study drug self-administration, before colonoscopy | |
| Secondary | Phase II - Dose finding: ease of use | Descriptive statistics (Mean) of Numeric Rating Scale (NRS) values ranging from 0 (very difficult) to 10 (very easy). | During visit 4, 4 hours after the end of study drug self-administration, before colonoscopy | |
| Secondary | Phase II - Dose finding: Willingness to reuse the preparation | Proportion of patient who confirmed that they would like to reuse the preparation for other colonoscopies. | During visit 4, 4 hours after the end of study drug self-administration, before colonoscopy | |
| Secondary | Phase II - Dose finding: Treatment acceptability | Descriptive statistics (Mean) of Numeric Rating Scale (NRS) values ranging from 0 (terrible) to 10 (very good). | During visit 4 (day of colonoscopy), 4 hours after the end of study drug self-administration, before colonoscopy | |
| Secondary | Phase II - Pharmacokinetic Parameter: Peak Plasma Concentration | descriptive statistics (mean) of peak plasma concentration (Cmax) as pharmacokinetic parameter. | During vist 4 (day of colonoscopy), before mannitol self-administration (T0 - baseline),1 hour (T1), 2 hours (T2), 4 hours (T4) and 8 hours (T8) after completion of mannitol self-administration | |
| Secondary | Phase II - Pharmacokinetic Parameter: Time to Maximum Concentration | Descriptive statistics (Median) of time to maximum concentration (tmax) as pharmacokinetic parameter. | During vist 4 (day of colonoscopy), before mannitol self-administration (T0 - baseline),1 hour (T1), 2 hours (T2), 4 hours (T4) and 8 hours (T8) after completion of mannitol self-administration | |
| Secondary | Phase II - Pharmacokinetic Parameter: Area Under the Curve | Descriptive statistics (Mean) of area under the curve from t0 to the last blood sampling time point (AUC 0-t8), as pharmacokinetic parameter. | During vist 4 (day of colonoscopy), before mannitol self-administration (T0 - baseline),1 hour (T1), 2 hours (T2), 4 hours (T4) and 8 hours (T8) after completion of mannitol self-administration | |
| Secondary | Phase II - Pharmacokinetic Parameter: Elimination Half Life | Descriptive statistics (Mean) of elimination half life (t1/2), as pharmacokinetic parameter. | During vist 4 (day of colonoscopy), before mannitol self-administration (T0 - baseline),1 hour (T1), 2 hours (T2), 4 hours (T4) and 8 hours (T8) after completion of mannitol self-administration | |
| Secondary | Phase III - Non-inferiority: Adenoma detection rate | The percentage of patients with at least one lesion detected. | During the colonoscopy at Visit 4 | |
| Secondary | Phase III - Non-inferiority: Ottawa Bowel Preparation Scale (OBPS) | Ottawa scale is used to measure the quality of the preparation in three different parts of the colon before washing and insufflation. descriptive statistics (Mean) of the total score (from 0 excellent to 14 inadequate). | During the colonoscopy at Visit 4 | |
| Secondary | Phase III - Non-inferiority: Caecal intubation rate | The percentage of patients with appendiceal orifice visible to the endoscopist. | During the colonoscopy at Visit 4 | |
| Secondary | Phase III - Non-inferiority: Bowel Cleansing Impact Review (BOCLIR) (Italian sites only) | The BOCLIR is a questionnaire filled in by patients to measure the acceptability and tolerability of bowel cleansers consisting of three unidimensional scales (satisfaction, symptoms and activity limitations) with good psychometric and scaling properties. Item responses are summed to provide a score for each scale and a total score. The satisfaction scale contains eight items and the score ranges from 0 (highly satisfied) to 32 (highly dissatisfied). The symptoms scale includes 14 items and the score ranges from 0 (no symptoms) to 42 (severe symptoms).
The activity limitations scale is made up of 12 items and the score ranges from 0 (no effect on activities) to 36 (activities greatly affected). The total score is the sum of the three scales and ranges from 0 to 110. Patients who report a worse experience in terms of the three factors score higher on the BOCLIR scale. |
Visit 4 after the end of study drug self-administration, before colonoscopy | |
| Secondary | Phase III - Non-inferiority: Adherence to bowel preparation with mannitol and with Moviprep®. | Proportion of patients that completely taken, partially taken or not taken assigned mannitol dose | During visit 4, 4 hours after the end of study drug self-administration, before colonoscopy | |
| Secondary | Phase III - Non-inferiority: ease of use | Descriptive statistics (Mean) of Numeric Rating Scale (NRS) values ranging from 0 (very difficult) to 10 (very easy). | During visit 4, 4 hours after the end of study drug self-administration, before colonoscopy | |
| Secondary | Phase III - Non-inferiority: Willingness to reuse the preparation | Proportion of patient who confirmed that they would like to reuse the preparation for other colonoscopies. | During visit 4, 4 hours after the end of study drug self-administration, before colonoscopy | |
| Secondary | Phase III - Non-inferiority: Treatment acceptability | Descriptive statistics (Mean) of Numeric Rating Scale (NRS) values ranging from 0 (terrible) to 10 (very good). | During visit 4, 4 hours after the end of study drug self-administration, before colonoscopy |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01647581 -
Risk of Post-polypectomy Bleeding With Prophylactic Hemoclipping
|
N/A |