Comparative study with intestinal preparation 1 L Peg + Asc with 4 L gold standard, both in split dose.

Intestinal preparation with new 1 L Peg + Asc solution or with gold standard 4 L Peg in split dose. Multicenter randomized controlled trial (OVER). - OVER2019 (One versus four) Study

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004543-24-IT

Enrollment

400

Registered

2020-11-06

Start date

2021-03-10

Completion date

Unknown

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Screening or surveillance or diagnostic colonoscopy. MedDRA version: 21.0 Level: PT Classification code 10010011 Term: Colonoscopy normal System Organ Class: 10022891 - Investigations

Interventions

Trade Name: SELG-ESSE Product Name: SELG-ESSE Product Code: [SELG-ESSE] Pharmaceutical Form: Powder for oral solution INN or Proposed INN: MACROGOL 4000/SODIO SOLFATO ANIDRO/SODIO BICARBONATO/SODIO CL

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients aged =18 aa and =85aa will be enrolled, who must undergo a screening, surveillance or diagnostic colonoscopy, capable of taking the preparation, without contraindications to the intake of the active ingredients of the two preparations. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: Patients under the age of 18 or over 85 years, pregnant women, patients unable to take the preparation, or with contraindications to taking the active ingredients of the two preparations

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the overall effectiveness of intestinal washing with 1 L Peg + Asc compared to 4 L Peg. The effectiveness of cleaning will be assessed according to the Boston scale (BBPS) by the blind endoscopist with respect to the type of preparation used. Cleanliness will be judged in case of score =6 and =2 in the individual segments;Secondary Objective: In the two study areas the following will be compared: • ADR, • PDR, Cecal intubation rate, • adequate cleansing in the right colon, • complementary (taking at least 75% of each dose) • frequency and intensity of adverse events • willingness to repeat the same preparation (only in patients who already are prepared in the last 24 months) • sleep quality • distress • need to interrupt the journey to the center • fecal incontinence;Primary end point(s): Percentage of patients with adequate cleaning (BBPS=6, single segment =2) in the 1L Peg + Asc treatment arm is no lower (lower confidence interval = -10%) than in the arm with 4L Peg treatment;Timepoint(s) of evaluation of this end point: 3 months	—

Measure

Time frame

Main Objective: Evaluate the overall effectiveness of intestinal washing with 1 L Peg + Asc compared to 4 L Peg. The effectiveness of cleaning will be assessed according to the Boston scale (BBPS) by the blind endoscopist with respect to the type of preparation used. Cleanliness will be judged in case of score =6 and =2 in the individual segments;Secondary Objective: In the two study areas the following will be compared: • ADR, • PDR, Cecal intubation rate, • adequate cleansing in the right colon, • complementary (taking at least 75% of each dose) • frequency and intensity of adverse events • willingness to repeat the same preparation (only in patients who already are prepared in the last 24 months) • sleep quality • distress • need to interrupt the journey to the center • fecal incontinence;Primary end point(s): Percentage of patients with adequate cleaning (BBPS=6, single segment =2) in the 1L Peg + Asc treatment arm is no lower (lower confidence interval = -10%) than in the arm with 4L Peg treatment;Timepoint(s) of evaluation of this end point: 3 months

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Secondary

Measure	Time frame
Secondary end point(s): ADR, PDR, cecal intubation rate, adequate cleaning in the right colon, compliance (taking at least 75% of each dose), frequency and intensity of adverse events, willingness to repeat the same preparation (only in patients who have already undergone preparation in the last 24 months), sleep quality, distress, need to stop traveling to the center, fecal incontinence;Timepoint(s) of evaluation of this end point: 3 months	—

Measure

Time frame

Secondary end point(s): ADR, PDR, cecal intubation rate, adequate cleaning in the right colon, compliance (taking at least 75% of each dose), frequency and intensity of adverse events, willingness to repeat the same preparation (only in patients who have already undergone preparation in the last 24 months), sleep quality, distress, need to stop traveling to the center, fecal incontinence;Timepoint(s) of evaluation of this end point: 3 months

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Countries

Italy

Contacts

Public ContactAmbulatorio di endoscopia digestiva

Ospedale Buccheri la Ferla, Fatebenefratelli

vassallorobertoblf@gmail.com091479385

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026