Phase 3
Completed N=886
Efficacy and Safety of mAnnitol in Bowel Preparation During Elective Colonoscopy and Comparison With Moviprep®
Elective Colonoscopy
Source: ClinicalTrials.gov NCT04759885 ↗
Enrolled (actual)
886
Serious AEs
0.5%
Results posted
Dec 2025
Primary outcomePrimary: Phase II - Dose Finding: Proportion of Patients With Adequate Bowel Cleansing — 0.75; 0.94; 0.94 Proportion of patients
◆ Published Evidence
Emerging
11citations · ~4 / year
Factors influencing the presence of potentially explosive gases during colonoscopy: Results of the SATISFACTION study.
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 .
Linked Publications (2)
-
Factors influencing the presence of potentially explosive gases during colonoscopy: Results of the SATISFACTION study.
-
Assessment of Patient-Reported Outcome Measures in Patients Undergoing Bowel Preparation With Mannitol for Colonoscopy: The SATISFACTION Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase II - Dose Finding: Proportion of Patients With Adequate Bowel Cleansing |
0.75; 0.94; 0.94 | — |
| PRIMARY Phase III - Non-inferiority: Proportion of Patients With Adequate Bowel Cleansing |
0.91; 0.95 | — |
| SECONDARY Phase II - Dose Finding: Caecal Intubation Rate |
0.92; 1; 1 | — |
| SECONDARY Phase II - Dose Finding: Adherence to Bowel Preparation |
60; 54; 49 | — |
| SECONDARY Phase II - Dose Finding: Ease of Use |
9.6; 9.3; 9.1 | — |
| SECONDARY Phase II - Dose Finding: Willingness to Reuse the Preparation |
60; 51; 46; 0; 3; 3 | — |
| SECONDARY Phase II - Dose Finding: Treatment Acceptability |
9.2; 8.3; 8.0 | — |
| SECONDARY Phase II - Pharmacokinetic Parameter: Peak Plasma Concentration |
0.6304; 1.0236; 1.3729 | — |
| SECONDARY Phase II - Pharmacokinetic Parameter: Time to Maximum Concentration |
1.1173; 1.3636; 1.4488 | — |
| SECONDARY Phase II - Pharmacokinetic Parameter: Area Under the Curve |
2.2313; 4.1591; 5.8476 | — |
| SECONDARY Phase II - Pharmacokinetic Parameter: Terminal Elimination Half Life |
2.5838; 2.4186; 2.6782 | — |
| SECONDARY Phase III - Non-inferiority: Adenoma Detection Rate |
98; 103; 235; 244 | — |
| SECONDARY Phase III - Non-inferiority: Ottawa Bowel Preparation Scale (OBPS) |
4.4; 3.6 | — |
| SECONDARY Phase III - Non-inferiority: Caecal Intubation Rate |
327; 345; 6; 2 | — |
| SECONDARY Phase III - Non-inferiority: Bowel Cleansing Impact Review (BOCLIR) (Italian Sites Only) |
23.5; 31.5 | — |
| SECONDARY Phase III - Non-inferiority: Adherence to Bowel Preparation With Mannitol and With Moviprep®. |
341; 341; 0; 6 | — |
| SECONDARY Phase III - Non-inferiority: Ease of Use |
9.3; 8.5 | — |
| SECONDARY Phase III - Non-inferiority: Willingness to Reuse the Preparation |
331; 272; 10; 75 | — |
| SECONDARY Phase III - Non-inferiority: Treatment Acceptability |
8.3; 5.6 | — |
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT04759885) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.