Elective ColonoscopyPhase 2/3SATISFACTIONNCT04759885
Efficacy and Safety of mAnnitol in Bowel Preparation During Elective Colonoscopy and Comparison With Moviprep®
A Phase 2/3 study testing Phase II: NTC015 low dose, Phase II: NTC015 medium dose and Phase II: NTC015 high dose in people with Elective Colonoscopy, run by NTC srl at 35 sites in 4 countries.
Trial 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 single dose mannitol vs standard split 2L PEG ASC (Moviprep®) (phase III) in bowel preparation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elective Colonoscopy
- What is being tested?
- Phase II: NTC015 low dose, Phase II: NTC015 medium dose and Phase II: NTC015 high dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 886 participants
- Where
- 35 sitesin 4 countries
- Study dates
- 18 Jun 2020to 16 Jul 2021
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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).
Trial locations and contacts
35 sites in 4 countries.
35 sites in 4 countries
Italy19 sites
Centro di Riferimento Oncologico IRCCS
Aviano, PN, 33081
Fondazione Poliambulanza - Istituto Ospedaliero
Brescia, BR, 25124
Azienda USL di Modena - Ospedale Ramazzini di Carpi
Carpi, MO, 41012
IRCCS "Saverio De Bellis"
Castellana Grotte, BA, 70013
Ospedale Valduce
Como, CO
ASST Rhodense - Presidi di Rho e Garbagnate
Garbagnate Milanese, MI, 20024
ASSL Carbonia - Presidio Ospedaliero CTO di Iglesias
Iglesias, CI
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano
Milan, MI, 20122
ASST Grande Ospedale Metropolitano Niguarda
Milan, MI, 20162
IRCCS Ospedale San Raffaele
Milan, MI
Istituto Europeo di Oncologia
Milan, MI
Ospedale Sacro Cuore
Negrar, VR, 37024
Azienda Ospedaliero-Universitaria Maggiore della Carità
Novara, 28100
Azienda Ospedaliero Universitaria Pisana- Ospedale Cisanello
Pisa, PI, 56124
Policlinico Universitario A. Gemelli
Roma, RO, 00168
IRCCS Policlinico San Donato
San Donato Milanese, MI, 20097
Fondazione Casa Sollievo Della Sofferenza
San Giovanni Rotondo, FG, 71013
Presidio Ospedaliero Santa Chiara
Trento, TN, 38100
ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi
Varese, 21100
Russia8 sites
Irkutsk State Medical Academy of Postgraduate Education
Irkutsk
Clinical Hospital of Russian Railways N.A. Semashko
Moscow
Moscow Clinical Research and Practical Center of the Department of Health
Moscow
State Central Clinical Hospital A. N. Ryzhykh
Moscow
Railway Clinical Hospital
Rostov-on-Don
Private educational organization of higher education "Medical University "Reaviz"
Samara
Medical Center of Diagnostics and Prevention
Yaroslavl
Regional Oncological Clinical Hospital
Yaroslavl
France4 sites
Centre Hospitalier Henri Duffaut
Avignon
Hospices civils de Lyon
Lyon
Hôpital Edouard Herriot
Lyon
Centre Hospitalier Universitaire de Montpellier
Montpellier
Germany4 sites
Klinikum der Stadt Ludwigshafen
Ludwigshafen
Praxis für Gastroenterologie und Fachärztliche Innere Medizin, Im Haus der Gesundheit
Ludwigshafen am Rhein
Katholisches Klinikum Mainz
Mainz
Klinikum Worms Medizinische Klinik II
Worms
About this study
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
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 .
Read the detailed description
Study Start and Study Completion dates relative to the Phase II/III are reported here:
Phase II (Patients n. 183)
- Date of first enrolment: 18 June 2020
- Date LPLV: 12 November 2020
Phase III (Patients n. 703)
- Date of first enrolment: 2 March 2021
- Date LPLV: 16 July 2021
Date on which the study was entered in the EudraCT database: 13 October 2020
- Conditions
- Elective Colonoscopy
- Being tested
- Phase II: NTC015 low dose, Phase II: NTC015 medium dose, Phase II: NTC015 high dose, Phase III: NTC015 selected dose, Phase III: Polyethylene glycol plus ascorbate solution (2L PEG ASC)
- Keywords
- Colonoscopy preparation, Bowel cleansing, Gas, Mannitol
- Medical subject headings
- Mucopolysaccharidosis IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase II: NTC015 low doseDrug
Participants should self administer the preparation within 30 minutes and drink clear liquid according to local practice at the centre to prevent dehydration
Phase II: NTC015 medium doseDrug
Participants should self administer the preparation within 30 minutes and drink clear liquid according to local practice at the centre to prevent dehydration
Phase II: NTC015 high doseDrug
Participants should self administer the preparation within 60 minutes and drink clear liquid according to local practice at the centre to prevent dehydration
Phase III: NTC015 selected doseDrug
Participants should self administer the preparation within 30 minutes and drink clear liquid according to local practice at the centre to prevent dehydration
Phase III: Polyethylene glycol plus ascorbate solution (2L PEG ASC)Drug
Also called Moviprep®
The instructions for product administration are followed according to the Summary of Product Characteristics.
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.
| Study group | Role | What they receive |
|---|---|---|
| Phase II: NTC015 low dose (Mannitol 50 g) | Experimental | One day single dose preparation same day of colonoscopy Receives: Drug: Phase II: NTC015 low dose |
| Phase II: NTC015 medium dose (Mannitol 100 g) | Experimental | One day single dose preparation same day of colonoscopy Receives: Drug: Phase II: NTC015 medium dose |
| Phase II: NTC015 high dose (Mannitol 150 g) | Experimental | One day single dose preparation same day of colonoscopy Receives: Drug: Phase II: NTC015 high dose |
| Phase III: NTC015 selected dose | Experimental | One day single dose preparation same day of colonoscopy Receives: Drug: Phase III: NTC015 selected dose |
| Phase III: Polyethylene glycol plus ascorbate solution (2L PEG ASC) (Moviprep®) | Active comparator | Two litres of Moviprep® taken according to split-dose regimen (to commence in the evening before colonoscopy) Receives: Drug: Phase III: Polyethylene glycol plus ascorbate solution (2L PEG ASC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 ≥ 2 during colonoscopy after standard washing and air insufflation for luminal distension.
The mannitol dose to be used in phase III was singled out on an algorithm that calculated a total score for each dose starting from the scores assigned to the three main criteria through a ranking system and proportionally to the importance given to each main criterion: A - rate of adequate bowel cleansing (most important - primary endpoint), B - rate of patients in safe conditions and C - clinical judgement score (least important - partially based on subjective assessments).
Measured: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed
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.
Measured: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed, at least 4 hours after end of intake, following product instruction as per protocol
Secondary outcomes (17)
Phase II - Dose Finding: Caecal Intubation Rate
The percentage of patients with appendiceal orifice visible to the endoscopist. Evaluation will be performed during conduction of colonoscopy run on visit 4. Timing for treatment administration was described in the protocol and change among arms.
Measured: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed
Phase II - Dose Finding: Adherence to Bowel Preparation
Proportion of patient that completely taken assigned mannitol dose.
Measured: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed, 4 hours after the end of study drug self-administration, before colonoscopy
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).
Measured: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. 4 hours after the end of study drug self-administration, before colonoscopy (please refer to protocol)
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.
Measured: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. 4 hours after the end of study drug self-administration, before colonoscopy
Phase II - Dose Finding: Treatment Acceptability
Descriptive statistics (Mean) of Numeric Rating Scale (NRS) values ranging from 0 (terrible) to 10 (very good).
Measured: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. 4 hours after the end of study drug self-administration, before colonoscopy
Phase II - Pharmacokinetic Parameter: Peak Plasma Concentration
descriptive statistics (mean) of peak plasma concentration (Cmax) as pharmacokinetic parameter.
Measured: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. Before mannitol self-administration and 8 hours (T8) after completion of mannitol self-administration
Phase II - Pharmacokinetic Parameter: Time to Maximum Concentration
Descriptive statistics (Median) of time to maximum concentration (tmax) as pharmacokinetic parameter.
Measured: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. Before mannitol self-administration and 8 hours (T8) after completion of mannitol self-administration
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.
Measured: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. Before mannitol self-administration and 8 hours (T8) after completion of mannitol self-administration
Phase II - Pharmacokinetic Parameter: Terminal Elimination Half Life
Descriptive statistics (Mean) of elimination half life (t1/2), as pharmacokinetic parameter.
Measured: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. Before mannitol self-administration and 8 hours (T8) after completion of mannitol self-administration
Phase III - Non-inferiority: Adenoma Detection Rate
The percentage of patients with at least one lesion detected.
Measured: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed
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).
Measured: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed
Phase III - Non-inferiority: Caecal Intubation Rate
The percentage of patients with appendiceal orifice visible to the endoscopist.
Measured: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed
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.
Measured: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. After the end of study drug self-administration, before colonoscopy
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
Measured: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. 4 hours after the end of study drug self-administration, before colonoscopy
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).
Measured: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. 4 hours after the end of study drug self-administration, before colonoscopy
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.
Measured: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. 4 hours after the end of study drug self-administration, before colonoscopy
Phase III - Non-inferiority: Treatment Acceptability
Descriptive statistics (Mean) of Numeric Rating Scale (NRS) values ranging from 0 (terrible) to 10 (very good).
Measured: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. 4 hours after the end of study drug self-administration, before colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start18 Jun 2020
- Primary completion16 Jul 2021
- Study completion16 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Elective ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, parallel-group study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 886 participants (actual)
Sponsor and investigators
- Lead sponsor
- NTC srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gianpiero Manes, Dr., Principal investigator, ASST Rhodense - Presidi di Rho e Garbagnate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759885
- Sponsor's protocol ID
- Mannitol_03-2018
- Other IDs
- 2019-002856-18, 2019
- Acronym
- SATISFACTION
- Status last verified
- Dec 2025
- First submitted
- 30 Nov 2020
- Last updated
- 8 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tontini GE, Spada C, Uebel P, Cannizzaro R, Ciprandi G, Vecchi M. Assessment of Patient-Reported Outcome Measures in Patients Undergoing Bowel Preparation With Mannitol for Colonoscopy: The SATISFACTION Study. JGH Open. 2025 Aug 7;9(8):e70237. doi: 10.1002/jgh3.70237. eCollection 2025 Aug.
PubMed 40786127Carnovali M, Spada C, Uebel P, Bocus P, Cannizzaro R, Cavallaro F, Cesana BM, Cesaro P, Costamagna G, Di Paolo D, Ferrari AP, Hinkel C, Kashin S, Massella A, Melnikova E, Orsatti A, Ponchon T, Prada A, Radaelli F, Sferrazza S, Soru P, Testoni PA, Tontini GE, Vecchi M, Fiori G; SATISFACTION Study Group. Factors influencing the presence of potentially explosive gases during colonoscopy: Results of the SATISFACTION study. Clin Transl Sci. 2023 May;16(5):759-769. doi: 10.1111/cts.13486. Epub 2023 Feb 17.
PubMed 36799346
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04759885
- Acronym / sponsor ID
- SATISFACTION / Mannitol_03-2018
- Conditions
- Elective Colonoscopy
- Keywords
- Colonoscopy preparation, Bowel cleansing, Gas, Mannitol
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 886 participants (actual)
- Lead sponsor
- NTC srlIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 16 Jul 2021 (actual)
- Study completion
- 16 Jul 2021 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Posted 8 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed description
Study Start and Study Completion dates relative to the Phase II/III are reported here:
Phase II (Patients n. 183)
- Date of first enrolment: 18 June 2020
- Date LPLV: 12 November 2020
Phase III (Patients n. 703)
- Date of first enrolment: 2 March 2021
- Date LPLV: 16 July 2021
Date on which the study was entered in the EudraCT database: 13 October 2020
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- Model description
- A randomized, parallel-group study.
| Arm | Type | Receives |
|---|---|---|
| Phase II: NTC015 low dose (Mannitol 50 g) | Experimental | Drug: Phase II: NTC015 low doseOne day single dose preparation same day of colonoscopy |
| Phase II: NTC015 medium dose (Mannitol 100 g) | Experimental | Drug: Phase II: NTC015 medium doseOne day single dose preparation same day of colonoscopy |
| Phase II: NTC015 high dose (Mannitol 150 g) | Experimental | Drug: Phase II: NTC015 high doseOne day single dose preparation same day of colonoscopy |
| Phase III: NTC015 selected dose | Experimental | Drug: Phase III: NTC015 selected doseOne day single dose preparation same day of colonoscopy |
| Phase III: Polyethylene glycol plus ascorbate solution (2L PEG ASC) (Moviprep®) | Active comparator | Drug: Phase III: Polyethylene glycol plus ascorbate solution (2L PEG ASC)Two litres of Moviprep® taken according to split-dose regimen (to commence in the evening before colonoscopy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phase II: NTC015 low doseParticipants should self administer the preparation within 30 minutes and drink clear liquid according to local practice at the centre to prevent dehydration | Drug | Phase II: NTC015 low dose (Mannitol 50 g) |
| Phase II: NTC015 medium doseParticipants should self administer the preparation within 30 minutes and drink clear liquid according to local practice at the centre to prevent dehydration | Drug | Phase II: NTC015 medium dose (Mannitol 100 g) |
| Phase II: NTC015 high doseParticipants should self administer the preparation within 60 minutes and drink clear liquid according to local practice at the centre to prevent dehydration | Drug | Phase II: NTC015 high dose (Mannitol 150 g) |
| Phase III: NTC015 selected doseParticipants should self administer the preparation within 30 minutes and drink clear liquid according to local practice at the centre to prevent dehydration | Drug | Phase III: NTC015 selected dose |
| Phase III: Polyethylene glycol plus ascorbate solution (2L PEG ASC)Also: Moviprep®The instructions for product administration are followed according to the Summary of Product Characteristics. 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. | Drug | Phase III: Polyethylene glycol plus ascorbate solution (2L PEG ASC) (Moviprep®) |
Primary outcome
Phase II - Dose Finding: Proportion of Patients With Adequate Bowel Cleansing
Time frame: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed
Proportion of patients with adequate bowel cleansing, defined as BBPS total score ≥ 6, with a score for each of the three colon segments ≥ 2 during colonoscopy after standard washing and air insufflation for luminal distension. The mannitol dose to be used in phase III was singled out on an algorithm that calculated a total score for each dose starting from the scores assigned to the three main criteria through a ranking system and proportionally to the importance given to each main criterion: A - rate of adequate bowel cleansing (most important - primary endpoint), B - rate of patients in safe conditions and C - clinical judgement score (least important - partially based on subjective assessments).
Phase III - Non-inferiority: Proportion of Patients With Adequate Bowel Cleansing
Time frame: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed, at least 4 hours after end of intake, following product instruction as per protocol
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.
17 secondary outcomes
Phase II - Dose Finding: Caecal Intubation Rate
Time frame: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed
Phase II - Dose Finding: Adherence to Bowel Preparation
Time frame: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed, 4 hours after the end of study drug self-administration, before colonoscopy
Phase II - Dose Finding: Ease of Use
Time frame: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. 4 hours after the end of study drug self-administration, before colonoscopy (please refer to protocol)
Phase II - Dose Finding: Willingness to Reuse the Preparation
Time frame: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. 4 hours after the end of study drug self-administration, before colonoscopy
Phase II - Dose Finding: Treatment Acceptability
Time frame: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. 4 hours after the end of study drug self-administration, before colonoscopy
Phase II - Pharmacokinetic Parameter: Peak Plasma Concentration
Time frame: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. Before mannitol self-administration and 8 hours (T8) after completion of mannitol self-administration
Phase II - Pharmacokinetic Parameter: Time to Maximum Concentration
Time frame: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. Before mannitol self-administration and 8 hours (T8) after completion of mannitol self-administration
Phase II - Pharmacokinetic Parameter: Area Under the Curve
Time frame: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. Before mannitol self-administration and 8 hours (T8) after completion of mannitol self-administration
Phase II - Pharmacokinetic Parameter: Terminal Elimination Half Life
Time frame: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. Before mannitol self-administration and 8 hours (T8) after completion of mannitol self-administration
Phase III - Non-inferiority: Adenoma Detection Rate
Time frame: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed
Phase III - Non-inferiority: Ottawa Bowel Preparation Scale (OBPS)
Time frame: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed
Phase III - Non-inferiority: Caecal Intubation Rate
Time frame: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed
Phase III - Non-inferiority: Bowel Cleansing Impact Review (BOCLIR) (Italian Sites Only)
Time frame: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. After the end of study drug self-administration, before colonoscopy
Phase III - Non-inferiority: Adherence to Bowel Preparation With Mannitol and With Moviprep®.
Time frame: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. 4 hours after the end of study drug self-administration, before colonoscopy
Phase III - Non-inferiority: Ease of Use
Time frame: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. 4 hours after the end of study drug self-administration, before colonoscopy
Phase III - Non-inferiority: Willingness to Reuse the Preparation
Time frame: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. 4 hours after the end of study drug self-administration, before colonoscopy
Phase III - Non-inferiority: Treatment Acceptability
Time frame: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. 4 hours after the end of study drug self-administration, before colonoscopy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40786127Tontini GE, Spada C, Uebel P, Cannizzaro R, Ciprandi G, Vecchi M. Assessment of Patient-Reported Outcome Measures in Patients Undergoing Bowel Preparation With Mannitol for Colonoscopy: The SATISFACTION Study. JGH Open. 2025 Aug 7;9(8):e70237. doi: 10.1002/jgh3.70237. eCollection 2025 Aug.
- Derived from this study: PubMed 36799346Carnovali M, Spada C, Uebel P, Bocus P, Cannizzaro R, Cavallaro F, Cesana BM, Cesaro P, Costamagna G, Di Paolo D, Ferrari AP, Hinkel C, Kashin S, Massella A, Melnikova E, Orsatti A, Ponchon T, Prada A, Radaelli F, Sferrazza S, Soru P, Testoni PA, Tontini GE, Vecchi M, Fiori G; SATISFACTION Study Group. Factors influencing the presence of potentially explosive gases during colonoscopy: Results of the SATISFACTION study. Clin Transl Sci. 2023 May;16(5):759-769. doi: 10.1111/cts.13486. Epub 2023 Feb 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianpiero Manes, Dr. principal investigator
ASST Rhodense - Presidi di Rho e Garbagnate
35 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Phase II: NTC015 low dose, Phase II: NTC015 medium dose and Phase II: NTC015 high dose in people with Elective Colonoscopy, run by NTC srl at 35 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Italy, Russia, France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase II - Dose Finding: Proportion of Patients With Adequate Bowel Cleansing (time frame: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04759885, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.