Efficacy and Safety of mAnnitol in Bowel Preparation During Elective Colonoscopy and Comparison With Moviprep® (SATISFACTION)
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| ClinicalTrials.gov Identifier: NCT04759885 |
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Recruitment Status :
Active, not recruiting
First Posted : February 18, 2021
Last Update Posted : February 18, 2021
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Sponsor:
NTC srl
Information provided by (Responsible Party):
NTC srl
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Brief Summary:
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 mannitol vs standard split 2L PEG ASC (Moviprep®) (phase III) in bowel preparation for colonoscopy .
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Screening Colonoscopy | Drug: NTC015 low dose Drug: NTC015 medium dose Drug: NTC015 high dose Drug: Polyethylene glycol plus ascorbate solution (2L PEG ASC) | Phase 2 Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 846 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | A randomized, parallel-group study. |
| Masking: | Single (Care Provider) |
| Masking Description: | Endoscopist-blinded |
| Primary Purpose: | Treatment |
| Official 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 |
| Actual Study Start Date : | June 18, 2020 |
| Estimated Primary Completion Date : | February 11, 2021 |
| Estimated Study Completion Date : | February 11, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Colonoscopy
Drug Information available for:
MoviPrep
| Arm | Intervention/treatment |
|---|---|
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Experimental: NTC015 low dose
One day single dose preparation same day of colonoscopy
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Drug: NTC015 low dose
Participants should self administer the preparation within 30 minutes and drink one litre of clear liquid in the next hour according to local practice at the centre to prevent dehydration |
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Experimental: NTC015 medium dose
One day single dose preparation same day of colonoscopy
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Drug: NTC015 medium dose
Participants should self administer the preparation within 30 minutes and drink one litre of clear liquid in the next hour according to local practice at the centre to prevent dehydration |
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Experimental: NTC015 high dose
One day single dose preparation same day of colonoscopy
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Drug: NTC015 high dose
Participants should self administer the preparation within 60 minutes and drink one litre of clear liquid in the next hour according to local practice at the centre to prevent dehydration |
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Active Comparator: Polyethylene glycol plus ascorbate solution (2L PEG ASC) (Moviprep®)
Two litres of Moviprep® taken according to split-dose regimen (to commence in the evening before colonoscopy)
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Drug: Polyethylene glycol plus ascorbate solution (2L PEG ASC)
One treatment consists of two litres of Moviprep® taken according to split-dose regimen. The first litre of Moviprep® is prepared by dissolving one sachet A and one sachet B together in water to make one litre of solution. The reconstituted solution must be drunk over a period of one to two hours the evening before colonoscopy. About half a litre of clear liquid should be drunk in the next hour to prevent dehydration according to local practice at the centre. This process should be repeated with a second litre of Moviprep® prepared by dissolving one sachet A and one sachet B together in water to make one litre of solution in the early morning of the day of the procedure. Other Name: Moviprep® |
Primary Outcome Measures :
- Phase II - Dose finding: Proportion of patients with adequate bowel cleansing defined by the Boston Bowel Preparation Scale (BBPS) total score [ Time Frame: During colonoscopy (Visit 4) after standard washing and air insufflation for luminal distension, assessed as Day 0 ]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.
- Phase III - Non-inferiority: Proportion of patients with adequate bowel cleansing defined by the BBPS total score [ Time Frame: During colonoscopy (Visit 4) after standard washing and air insufflation for luminal distension, assessed as Day 0 ]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.
Secondary Outcome Measures :
- Phase II - Dose finding: Caecal intubation rate [ Time Frame: During colonoscopy at Visit 4, assessed as Day 0 ]Caecal intubation rate, defined as the percentage of patients with appendiceal orifice visible to the endoscopist.
- Phase II - Dose finding: Proportion of patients in safe conditions defined by the absence in each colon segment of potentially dangerous levels of H2 and/or CH4 [ Time Frame: During colonoscopy at Visit 4 after standard washing and air insufflation for luminal distension, assessed as Day 0 ]Measurement of gases in three colon segments
- Phase II - Dose finding: Incidence of adverse events [ Time Frame: At Visit 1 (≤ 28 days before Visit 4), Visit 2 (≤ 7 days before Visit 4), Visit 3 (≤ 7 days before Visit 4) and Visit 4 (Day 0) ]Incidence of adverse events from the beginning of study drug self-administration.
- Phase II - Dose finding: Proportion of patients with clinically significant change of haematological and chemical parameters from baseline [ Time Frame: At Visit 2 (≤ 7 days before Visit 4) and Visit 4 (Day 0) ]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.
- Phase II - Dose finding: Proportion of patients with clinically significant change of vital signs during colonoscopy [ Time Frame: During the colonoscopy at Visit 4, assessed as day 0 ]Proportion of patients with change during colonoscopy considered clinically significant by the Investigator of vital signs (heart rate and pulse oximetry).
- Phase II - Dose finding: Adherence to bowel preparation with mannitol [ Time Frame: 4 hours after the end of study drug self-administration, before colonoscopy ]Adherence: study drug completely taken, partially taken, not taken
- Phase II - Dose finding: Numeric rating scale (NRS) score for ease of use [ Time Frame: 4 hours after the end of study drug self-administration, before colonoscopy (Day 0) ]Ease of use: NRS (0 = very difficult to 10 = very easy)
- Phase II - Dose finding: Willingness to reuse the preparation [ Time Frame: 4 hours after the end of study drug self-administration, before colonoscopy (Day 0) ]Willingness to reuse the preparation (yes/no)
- Phase II - Dose finding: Treatment acceptability score [ Time Frame: 4 hours after the end of study drug self-administration, before colonoscopy (Day 0) ]Taste: NRS (0 = terrible to 10 = very good)
- Phase II - Detection of the Pharmacokinetic Parameters: Peak Plasma Concentration (Cmax) [ Time Frame: During visit 4 (Day 0), 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 ]Peak Plasma Concentration (Cmax): maximum concentration
- Phase II - Detection of the Pharmacokinetic Parameters: Area under the plasma concentration versus time curve (AUC) [ Time Frame: During visit 4 (Day 0), 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 ]AUC0-t0-t: area under concentration-time curve, from 0 to the last blood sampling time point with measurable concentration.
- Phase II - Detection of the Pharmacokinetic Parameters: Time to maximum concentration (tmax) [ Time Frame: During visit 4 (Day 0), 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 ]tmax: time to maximum concentration
- Phase II - Detection of the Pharmacokinetic Parameters: Elimination half-life (t1/2) [ Time Frame: During visit 4 (Day 0), 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 ]t1/2: elimination half-life
- Phase III - Non-inferiority: Adenoma detection rate [ Time Frame: During the colonoscopy at Visit 4, assessed as day 0 ]Adenoma detection rate, defined as the percentage of patients with at least one lesion detected.
- Phase III - Non-inferiority: Ottawa Scale (OS) for bowel preparation [ Time Frame: During the colonoscopy at Visit 4, assessed as day 0 ]Ottawa scale is used to measure the quality of the preparation in three different parts of the colon. Score: 0 excellent, 1 good, 2 fair, 3 poor, 4 inadequate.
- Phase III - Non-inferiority: Caecal intubation rate [ Time Frame: During the colonoscopy at Visit 4, assessed as day 0 ]Caecal intubation rate, defined as the percentage of patients with appendiceal orifice visible to the endoscopist.
- Phase III - Non-inferiority: Proportion of patients in safe conditions defined by the absence in each colon segment of potentially dangerous levels of H2 and/or CH4 [ Time Frame: During the colonoscopy at Visit 4, assessed as day 0 ]Measurement of gases in three colon segments
- Phase III - Non-inferiority: Incidence of adverse events [ Time Frame: At Visit 1 (≤ 28 days before Visit 4), Visit 2 (≤ 7 days before Visit 4), Visit 3 (≤ 7 days before Visit 4) and Visit 4 (Day 0) ]Incidence of adverse events from the beginning of study drug self-administration.
- Phase III - Non-inferiority: Proportion of patients with clinically significant change of haematological and chemical parameters from baseline [ Time Frame: At Visit 2 (≤ 7 days before Visit 4) and Visit 4 (Day 0) ]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.
- Phase III - Non-inferiority: Proportion of patients with clinically significant change of vital signs from baseline and during colonoscopy [ Time Frame: At Visit 2 (≤ 7 days before Visit 4) and Visit 4 prior to colonoscopy, assessed as Day 0 ]Proportion of patients with change from baseline considered clinically significant by the Investigator of vital signs (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.
- Phase III - Non-inferiority: Bowel Cleansing Impact Review (BOCLIR) score (Italian sites only) [ Time Frame: 4 hours after the end of study drug self-administration, before colonoscopy (Day 0) ]The BOCLIR is a measure of 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 scale scores.
- Phase III - Non-inferiority: Adherence to bowel preparation with mannitol and with Moviprep®. [ Time Frame: 4 hours after the end of study drug self-administration, before colonoscopy ]Adherence: study drug completely taken, partially taken, not taken
- Phase III - Non-inferiority: Numeric rating scale (NRS) score for ease of use [ Time Frame: 4 hours after the end of study drug self-administration, before colonoscopy (Day 0) ]Ease of use: NRS (0 = very difficult to 10 = very easy)
- Phase III - Non-inferiority: Willingness to reuse the preparation [ Time Frame: 4 hours after the end of study drug self-administration, before colonoscopy (Day 0) ]Willingness to reuse the preparation (yes/no)
- Phase III - Non-inferiority: Treatment acceptability score [ Time Frame: 4 hours after the end of study drug self-administration, before colonoscopy (Day 0) ]Taste: NRS (0 = terrible to 10 = very good)
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Ability of patient to consent and provide signed written informed consent
- Age ≥ 18 years
- 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
- Patients willing and able to complete the entire study and to comply with instructions
Exclusion Criteria:
- 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).
- Severe renal failure: glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2 estimated by means of simplified MDRD equation.
- Severe heart failure: NYHA Class III-IV.
- Severe anaemia (Hb ≤ 8 g/dl).
- 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.
- Chronic liver disease Child-Pugh class B or C.
- Electrolyte disturbances (Na, Cl, K, Ca or P out of normal ranges).
- 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.
- 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.
- Suspected bowel obstruction or perforation.
- Indication for partial colonoscopy.
- Patients who have received an investigational drug or therapy within 5 half-lives of the first visit.
- Patients previously screened for participation in this study.
- Hypersensitivity to the active ingredients or to any of the excipients of the study drugs.
- Contraindication to Moviprep® (only for phase III).
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04759885
Locations
Show 36 study locations
Sponsors and Collaborators
NTC srl
Investigators
| Principal Investigator: | Gianpiero Manes, Dr. | ASST Rhodense - Presidi di Rho e Garbagnate |
| Responsible Party: | NTC srl |
| ClinicalTrials.gov Identifier: | NCT04759885 |
| Other Study ID Numbers: |
Mannitol_03-2018 2019-002856-18 ( EudraCT Number ) |
| First Posted: | February 18, 2021 Key Record Dates |
| Last Update Posted: | February 18, 2021 |
| Last Verified: | February 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |