Trial · NCT04759885
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| 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. |
| Secondary | Phase II - Pharmacokinetic Parameter: Terminal Elimination Half Life | 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 elimination half life (t1/2), as pharmacokinetic parameter. |
| Secondary | Phase III - Non-inferiority: Adenoma Detection Rate | During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed | The percentage of patients with at least one lesion detected. |
| Secondary | Phase III - Non-inferiority: Ottawa Bowel Preparation Scale (OBPS) | During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed | 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). |
| Secondary | Phase III - Non-inferiority: 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. |
| Secondary | Phase III - Non-inferiority: Bowel Cleansing Impact Review (BOCLIR) (Italian Sites Only) | 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 | 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. |
| Secondary | Phase III - Non-inferiority: Adherence to Bowel Preparation With Mannitol and With Moviprep®. | 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 patients that completely taken, partially taken or not taken assigned mannitol dose |
| Secondary | Phase III - Non-inferiority: 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 | Descriptive statistics (Mean) of Numeric Rating Scale (NRS) values ranging from 0 (very difficult) to 10 (very easy). |
| Secondary | Phase III - Non-inferiority: 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 III - Non-inferiority: 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). |
| Other | 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 | Proportion of patients in safe condition for intestinal gases defined as concentration of potentially critical concentrations of gases (H2\>4% and CH4 \>5%) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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