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

NCT ID: NCT04759885

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 886 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-18
• Study Completion Date: 2021-07-16

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 .

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Phase II: NTC015 low dose (Mannitol 50 g)

One day single dose preparation same day of colonoscopy

Group Type: EXPERIMENTAL

Phase II: NTC015 low dose

Intervention Type: 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)

One day single dose preparation same day of colonoscopy

Group Type: EXPERIMENTAL

Phase II: NTC015 medium dose

Intervention Type: 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 high dose (Mannitol 150 g)

One day single dose preparation same day of colonoscopy

Group Type: EXPERIMENTAL

Phase II: NTC015 high dose

Intervention Type: 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 III: NTC015 selected dose

One day single dose preparation same day of colonoscopy

Group Type: EXPERIMENTAL

Phase III: NTC015 selected dose

Intervention Type: 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: 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)

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

Phase II: NTC015 low dose

Participants should self administer the preparation within 30 minutes and drink clear liquid according to local practice at the centre to prevent dehydration

Intervention Type: DRUG

Phase II: NTC015 medium dose

Participants should self administer the preparation within 30 minutes and drink clear liquid according to local practice at the centre to prevent dehydration

Intervention Type: DRUG

Phase II: NTC015 high dose

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

Intervention Type: DRUG

Phase III: NTC015 selected dose

Participants should self administer the preparation within 30 minutes and drink clear liquid according to local practice at the centre to prevent dehydration

Intervention Type: DRUG

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

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.

Intervention Type: DRUG

Other Intervention Names

Moviprep®

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NTC srl

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gianpiero Manes, Dr.

Role: PRINCIPAL_INVESTIGATOR

ASST Rhodense - Presidi di Rho e Garbagnate

Locations

Centre Hospitalier Henri Duffaut

Avignon, , France

Hospices civils de Lyon

Lyon, , France

Hôpital Edouard Herriot

Lyon, , France

Centre Hospitalier Universitaire de Montpellier

Montpellier, , France

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, , Germany

IRCCS "Saverio De Bellis"

Castellana Grotte, BA, Italy

Fondazione Poliambulanza - Istituto Ospedaliero

Brescia, BR, Italy

ASSL Carbonia - Presidio Ospedaliero CTO di Iglesias

Iglesias, CI, Italy

Ospedale Valduce

Como, CO, Italy

Fondazione Casa Sollievo Della Sofferenza

San Giovanni Rotondo, FG, Italy

ASST Rhodense - Presidi di Rho e Garbagnate

Garbagnate Milanese, MI, Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano

Milan, MI, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, MI, Italy

IRCCS Ospedale San Raffaele

Milan, MI, Italy

Istituto Europeo di Oncologia

Milan, MI, Italy

IRCCS Policlinico San Donato

San Donato Milanese, MI, Italy

Azienda USL di Modena - Ospedale Ramazzini di Carpi

Carpi, MO, Italy

Azienda Ospedaliero Universitaria Pisana- Ospedale Cisanello

Pisa, PI, Italy

Centro di Riferimento Oncologico IRCCS

Aviano, PN, Italy

Policlinico Universitario A. Gemelli

Roma, RO, Italy

Presidio Ospedaliero Santa Chiara

Trento, TN, Italy

Ospedale Sacro Cuore

Negrar, VR, Italy

Azienda Ospedaliero-Universitaria Maggiore della Carità

Novara, , Italy

ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi

Varese, , Italy

Irkutsk State Medical Academy of Postgraduate Education

Irkutsk, , Russia

Clinical Hospital of Russian Railways N.A. Semashko

Moscow, , Russia

Moscow Clinical Research and Practical Center of the Department of Health

Moscow, , Russia

State Central Clinical Hospital A. N. Ryzhykh

Moscow, , Russia

Railway Clinical Hospital

Rostov, , Russia

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

Samara, , Russia

Medical Center of Diagnostics and Prevention

Yaroslavl, , Russia

Regional Oncological Clinical Hospital

Yaroslavl, , Russia

Countries

France; Germany; Italy; Russia

References

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.

Reference Type: DERIVED

PMID: 40786127 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36799346 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2019-002856-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Mannitol_03-2018

Identifier Type: -

Identifier Source: org_study_id