Efficacy and Safety of mAnnitol in Bowel Preparation During Elective Colonoscopy and Comparison With Moviprep®

NCT04759885 | Completed Phase 2 Results

• 2 other identifiers: Mannitol_03-20182019-002856-18
• Study Type: interventional
• Target: 886
• Locations: 4 countries
• Sites: 35

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 single dose mannitol vs standard split 2L PEG ASC (Moviprep®) (phase III) in bowel preparation for colonoscopy .

Conditions

Elective Colonoscopy

Keywords

Colonoscopy preparation; Bowel cleansing; Gas; Mannitol

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  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

  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

  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

  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

  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

  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

Other Outcomes (8)

• Phase II - Dose Finding: Patients in Safe Condition Related to Potentially Critical Concentrations of Gases (H2/CH4)

  During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed after standard washing and air insufflation for luminal distension

• Phase II - Dose Finding: Incidence of Adverse Events

  Visit 2 (≤ 7 days before Visit 4), Visit 3 (≤ 7 days before Visit 4) and Visit 4 (during the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed)

• Phase II - Dose Finding: Proportion of Patients With Clinically Significant Change of Haematological and Chemical Parameters From Baseline

  During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. 4 hours and 8 hours after completion of study drug self administration

Study Arms (5)

Phase II: NTC015 low dose (Mannitol 50 g)

EXPERIMENTAL

One day single dose preparation same day of colonoscopy

Drug: Phase II: NTC015 low dose

Phase II: NTC015 medium dose (Mannitol 100 g)

EXPERIMENTAL

One day single dose preparation same day of colonoscopy

Drug: Phase II: NTC015 medium dose

Phase II: NTC015 high dose (Mannitol 150 g)

EXPERIMENTAL

One day single dose preparation same day of colonoscopy

Drug: Phase II: NTC015 high dose

Phase III: NTC015 selected dose

EXPERIMENTAL

One day single dose preparation same day of colonoscopy

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)

Drug: Phase III: Polyethylene glycol plus ascorbate solution (2L PEG ASC)

Interventions

Phase II: NTC015 low dose DRUG

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 low dose (Mannitol 50 g)

Phase II: NTC015 medium dose DRUG

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 dose (Mannitol 100 g)

Phase II: NTC015 high dose DRUG

Participants should self administer the preparation within 60 minutes and drink clear liquid according to local practice at the centre to prevent dehydration

Phase II: NTC015 high dose (Mannitol 150 g)

Phase III: NTC015 selected dose DRUG

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: NTC015 selected dose

Phase III: Polyethylene glycol plus ascorbate solution (2L PEG ASC) DRUG

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.

Also known as: Moviprep®

Phase III: Polyethylene glycol plus ascorbate solution (2L PEG ASC) (Moviprep®)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NTC srl: lead

Study Sites (35)

Centre Hospitalier Henri Duffaut

Avignon, France

Location

Hospices civils de Lyon

Lyon, France

Location

Hôpital Edouard Herriot

Lyon, France

Location

Centre Hospitalier Universitaire de Montpellier

Montpellier, France

Location

Klinikum der Stadt Ludwigshafen

Ludwigshafen, Germany

Location

Praxis für Gastroenterologie und Fachärztliche Innere Medizin, Im Haus der Gesundheit

Ludwigshafen am Rhein, Germany

Location

Katholisches Klinikum Mainz

Mainz, Germany

Location

Klinikum Worms Medizinische Klinik II

Worms, Germany

Location

IRCCS "Saverio De Bellis"

Castellana Grotte, BA, 70013, Italy

Location

Fondazione Poliambulanza - Istituto Ospedaliero

Brescia, BR, 25124, Italy

Location

ASSL Carbonia - Presidio Ospedaliero CTO di Iglesias

Iglesias, CI, Italy

Location

Ospedale Valduce

Como, CO, Italy

Location

Fondazione Casa Sollievo Della Sofferenza

San Giovanni Rotondo, FG, 71013, Italy

Location

ASST Rhodense - Presidi di Rho e Garbagnate

Garbagnate Milanese, MI, 20024, Italy

Location

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano

Milan, MI, 20122, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda

Milan, MI, 20162, Italy

Location

IRCCS Ospedale San Raffaele

Milan, MI, Italy

Location

Istituto Europeo di Oncologia

Milan, MI, Italy

Location

IRCCS Policlinico San Donato

San Donato Milanese, MI, 20097, Italy

Location

Azienda USL di Modena - Ospedale Ramazzini di Carpi

Carpi, MO, 41012, Italy

Location

Azienda Ospedaliero Universitaria Pisana- Ospedale Cisanello

Pisa, PI, 56124, Italy

Location

Centro di Riferimento Oncologico IRCCS

Aviano, PN, 33081, Italy

Location

Policlinico Universitario A. Gemelli

Roma, RO, 00168, Italy

Location

Presidio Ospedaliero Santa Chiara

Trento, TN, 38100, Italy

Location

Ospedale Sacro Cuore

Negrar, VR, 37024, Italy

Location

Azienda Ospedaliero-Universitaria Maggiore della Carità

Novara, 28100, Italy

Location

ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi

Varese, 21100, Italy

Location

Irkutsk State Medical Academy of Postgraduate Education

Irkutsk, Russia

Location

Clinical Hospital of Russian Railways N.A. Semashko

Moscow, Russia

Location

Moscow Clinical Research and Practical Center of the Department of Health

Moscow, Russia

Location

State Central Clinical Hospital A. N. Ryzhykh

Moscow, Russia

Location

Railway Clinical Hospital

Rostov, Russia

Location

Private educational organization of higher education "Medical University "Reaviz"

Samara, Russia

Location

Medical Center of Diagnostics and Prevention

Yaroslavl, Russia

Location

Regional Oncological Clinical Hospital

Yaroslavl, Russia

Location

Related Publications (2)

• 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.

  PMID: 40786127 DERIVED

• Carnovali 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.

  PMID: 36799346 DERIVED

MeSH Terms

Conditions

Mucopolysaccharidosis IV

Interventions

MoviPrep

Condition Hierarchy (Ancestors)

Mucopolysaccharidoses; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lysosomal Storage Diseases; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Alessandro Colombo
• Organization: NTC srl

alessandro.colombo@ntcpharma.com

+390243850490

Study Officials

• Gianpiero Manes, Dr.

  ASST Rhodense - Presidi di Rho e Garbagnate

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Endoscopist-blinded
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, parallel-group study.

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: February 18, 2021
• Study Start: June 18, 2020
• Primary Completion: July 16, 2021
• Study Completion: July 16, 2021
• Last Updated: December 8, 2025
• Results First Posted: December 8, 2025

Record last verified: 2025-12

Locations

IT (19); RU (8); FR (4); DE (4)