Trial · NCT04759885
Efficacy and Safety of mAnnitol in Bowel Preparation During Elective Colonoscopy and Comparison With Moviprep®
NCT04759885, Phase 2, Phase 3, Completed, NTC srl; results first posted 2025-12-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of mAnnitol in Bowel Preparation During Elective Colonoscopy and Comparison With Moviprep®. Trials, record NCT04759885. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04759885
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of mAnnitol in Bowel Preparation During Elective Colonoscopy and Comparison With Moviprep®
- NCT number
- NCT04759885
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 886 participants, actual
- Lead sponsor
- NTC srl
- Conditions
- Elective Colonoscopy
- Interventions
- 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)
- First posted
- 2021-02-18
- Last updated
- 2025-12-08
- Other registries' IDs
- eudract:2019-002856-18
- Results first posted
- 2025-12-08
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase II - Dose Finding: Proportion of Patients With Adequate Bowel Cleansing | 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). |
| Primary | Phase III - Non-inferiority: Proportion of Patients With Adequate Bowel Cleansing | 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. |
| Secondary | Phase II - Dose Finding: Caecal Intubation Rate | During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed | 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. |
| Secondary | 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 | Proportion of patient that completely taken assigned mannitol dose. |
| Secondary | 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) | Descriptive statistics (Mean) of Numeric Rating Scale (NRS) values ranging from 0 (very difficult) to 10 (very easy). |
| Secondary | 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 | Proportion of patient who confirmed that they would like to reuse the preparation for other colonoscopies. |
| Secondary | 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 | Descriptive statistics (Mean) of Numeric Rating Scale (NRS) values ranging from 0 (terrible) to 10 (very good). |
| Secondary | Phase II - Pharmacokinetic Parameter: Peak Plasma Concentration | 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 | descriptive statistics (mean) of peak plasma concentration (Cmax) as pharmacokinetic parameter. |
| Secondary | Phase II - Pharmacokinetic Parameter: Time to Maximum Concentration | 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 | Descriptive statistics (Median) of time to maximum concentration (tmax) as pharmacokinetic parameter. |
| Secondary | Phase II - Pharmacokinetic Parameter: Area Under the Curve | 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 | Descriptive statistics (Mean) of area under the curve from t0 to the last blood sampling time point (AUC 0-t8), as pharmacokinetic parameter. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase II - Dose Finding: Proportion of Patients With Adequate Bowel Cleansing | During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed | Percentages were computed on patients belonging to the PP population. | Proportion of patients | NUMBER |
| PRIMARY | Phase III - Non-inferiority: Proportion of Patients With Adequate Bowel Cleansing | 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 | Percentages were computed on patients belonging to the PP Population. | Proportion of patients | NUMBER |
| SECONDARY | Phase II - Dose Finding: Caecal Intubation Rate | During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed | Percentages were computed on patients belonging to the PP population. | Proportion of patients | NUMBER |
| SECONDARY | 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 | Percentages were computed on patients belonging to the PP population. Overall Number of Participants Analyzed referred to patient that completely taken assigned mannitol dose. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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) | Percentages were computed on patients belonging to the PP population. | Score | MEAN |
| SECONDARY | 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 | Percentages were computed on patients belonging to the PP population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | Percentages were computed on patients belonging to the PP population. | score on a scale | MEAN |
| SECONDARY | Phase II - Pharmacokinetic Parameter: Peak Plasma Concentration | 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 | Percentages were computed on patients belonging to the PK population. | Mannitol plasma concentrations (mg/mL) | MEAN |
| SECONDARY | Phase II - Pharmacokinetic Parameter: Time to Maximum Concentration | 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 | Percentages were computed on patients belonging to the PK population. | Hours | MEAN |
| SECONDARY | Phase II - Pharmacokinetic Parameter: Area Under the Curve | 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 | Percentages were computed on patients belonging to the PK population. | mg/mL*hours | MEAN |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group138
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase II - Dose Finding: Proportion of Patients With Adequate Bowel Cleansing | Phase II: NTC015 Low Dose | 0.75 | 95% Confidence Interval 0.64 to 0.86 | Proportion of patients | |
| Phase II - Dose Finding: Proportion of Patients With Adequate Bowel Cleansing | Phase II: NTC015 Medium Dose | 0.94 | 95% Confidence Interval 0.88 to 1 | Proportion of patients | |
| Phase II - Dose Finding: Proportion of Patients With Adequate Bowel Cleansing | Phase II: NTC015 High Dose | 0.94 | 95% Confidence Interval 0.87 to 1 | Proportion of patients | |
| Phase III - Non-inferiority: Proportion of Patients With Adequate Bowel Cleansing | Phase III: NTC015 Selected Dose | 0.91 | 95% Confidence Interval 0.88 to 0.94 | Proportion of patients | |
| Phase III - Non-inferiority: Proportion of Patients With Adequate Bowel Cleansing | Phase III: 2 L PEG ASC (Moviprep®) | 0.95 | 95% Confidence Interval 0.93 to 0.98 | Proportion of patients | |
| Phase II - Dose Finding: Caecal Intubation Rate | Phase II: NTC015 Low Dose | 0.92 | 95% Confidence Interval 0.85 to 0.99 | Proportion of patients | |
| Phase II - Dose Finding: Caecal Intubation Rate | Phase II: NTC015 Medium Dose | 1 | 95% Confidence Interval 1 to 1 | Proportion of patients | |
| Phase II - Dose Finding: Caecal Intubation Rate | Phase II: NTC015 High Dose | 1 | 95% Confidence Interval 1 to 1 | Proportion of patients | |
| Phase II - Dose Finding: Adherence to Bowel Preparation | Phase II: NTC015 Low Dose | 60 | Participants | ||
| Phase II - Dose Finding: Adherence to Bowel Preparation | Phase II: NTC015 Medium Dose | 54 | Participants |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase II: NTC015 Low Dose | 66 | |
| Overall Study | STARTED | Phase II: NTC015 Medium Dose | 57 | |
| Overall Study | STARTED | Phase II: NTC015 High Dose | 60 | |
| Overall Study | STARTED | Phase III: NTC015 Selected Dose | 352 | |
| Overall Study | STARTED | Phase III: 2L PEG ASC (Moviprep®) | 351 | |
| Overall Study | COMPLETED | Phase II: NTC015 Low Dose | 65 | |
| Overall Study | COMPLETED | Phase II: NTC015 Medium Dose | 57 | |
| Overall Study | COMPLETED | Phase II: NTC015 High Dose | 57 | |
| Overall Study | COMPLETED | Phase III: NTC015 Selected Dose | 338 | |
| Overall Study | COMPLETED | Phase III: 2L PEG ASC (Moviprep®) | 345 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events35
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | diverticulum intestinal | Gastrointestinal disorders | Phase II: NTC015 Low Dose | 2 | 65 | 2 |
| other | diverticulum intestinal | Gastrointestinal disorders | Phase II: NTC015 Medium Dose | 1 | 57 | 1 |
| other | diverticulum intestinal | Gastrointestinal disorders | Phase II: NTC015 High Dose | 4 | 57 | 4 |
| other | diverticulum intestinal | Gastrointestinal disorders | Phase III: NTC015 Selected Dose | 1 | 343 | 1 |
| other | diverticulum intestinal | Gastrointestinal disorders | Phase III:2 L PEG ASC (Moviprep®) | 2 | 347 | 2 |
| other | Vomiting | Gastrointestinal disorders | Phase II: NTC015 Low Dose | 1 | 65 | 1 |
| other | Vomiting | Gastrointestinal disorders | Phase II: NTC015 Medium Dose | 3 | 57 | 3 |
| other | Vomiting | Gastrointestinal disorders | Phase II: NTC015 High Dose | 8 | 57 | 8 |
| other | Vomiting | Gastrointestinal disorders | Phase III: NTC015 Selected Dose | 15 | 343 | 15 |
| other | Vomiting | Gastrointestinal disorders | Phase III:2 L PEG ASC (Moviprep®) | 2 | 347 | 2 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase II: NTC015 Low Dose | 0 | 65 |
| Total, all-cause mortality | Phase II: NTC015 Medium Dose | 0 | 57 |
| Total, all-cause mortality | Phase II: NTC015 High Dose | 0 | 57 |
| Total, all-cause mortality | Phase III: NTC015 Selected Dose | 0 | 343 |
| Total, all-cause mortality | Phase III:2 L PEG ASC (Moviprep®) | 0 | 347 |
| Total, other adverse events | Phase II: NTC015 Low Dose | 3 | 65 |
| Total, other adverse events | Phase II: NTC015 Medium Dose | 8 | 57 |
| Total, other adverse events | Phase II: NTC015 High Dose | 17 | 57 |
| Total, other adverse events | Phase III: NTC015 Selected Dose | 25 | 343 |
| Total, other adverse events | Phase III:2 L PEG ASC (Moviprep®) | 9 | 347 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Phase III: NTC015 Selected Dose vs Phase III: 2L PEG ASC (Moviprep®): Phase III - Non-inferiority: Proportion of Patients With Change of Vital Signs From Baseline and During Colonoscopy |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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