Evaluation of Two Different Regimens of Colon Preparations for Advanced Cleaning. (ERACLES)

Evaluation of Two Different Regimens of Colon Preparations for Advanced Cleaning Using a 2lt PEG-CS With Simethicone: a Randomized Controlled Study.

Multicenter, prospective, randomized, checked, open label, with blind evaluation, for compare the intestinal cleansing effectiveness of the regimen full-dose delayed (A) of Clensia vs split regimen (B) of Clensia, in patients undergoing endoscopy.

Study Overview

• Status: Completed
• Conditions: Colonoscopy
• Intervention / Treatment: Drug: (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) full dose; Drug: (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) split dose

Detailed Description

Enrolled patients, after providing written informed consent, are randomized to the CLENSIA preparation scheme, delayed full-dose or split-dose regimen. The delayed full-dose regimen will constitute study arm A while the split-dose regimen will constitute the control arm B.

Participants will follow a slag-free diet in the three days preceding the colonoscopy (reduction in the consumption of fruit, vegetables and legumes). On the day before the colonoscopy, patients will be able to have a normal breakfast and lunch that are both free of fiber. The dietary indications will be delivered in writing to the patient by the health staff of the center involved in the trial. From the moment the preparation begins with the intake of the product, the intake of solid foods will no longer be allowed while clear liquids of the patient's choice can be taken freely up to two hours before the colonoscopy.

The study ends for each patient with the execution of each procedure / examination planned for the visit 2 The effectiveness of the preparation in terms of intestinal cleansing is assessed blindly (by the endoscopist) using the scale (Boston Bowel Preparation Scale).

• Study Type: Interventional
• Enrollment (Actual): 321
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Belluno, Italy
    • SC Gastroenterologia ed Endoscopia Digestiva - Ospedale S. Martino
  • Bologna, Italy
    • Dipartimento di scienze mediche e chirurgiche, Università di Bologna - Policlinico Sant'Orsola
  • Crotone, Italy
    • Reparto Gastroenterologia ed Endoscopia dell'Ospedale Civile San Giovanni di Dio
  • Napoli, Italy
    • Servizio Centralizzato di Endoscopia Digestiva Operatoria - AOU Federico II
  • Pistoia, Italy
    • S.S. Endoscopia Digestiva/ P.O. S. Jacopo
  • Rome, Italy
    • Chirurgia Generale AOU Policlinico Umberto I
  • Avellino
    • Ariano Irpino, Avellino, Italy, 83031
      • Presidio Ospedaliero Sant'Ottone Frangipane
  • Bari
    • Castellana Grotte, Bari, Italy
      • Reparto di Gastroenterologia IRRCS Saverio de Bellis
  • Brescia
    • Manerbio, Brescia, Italy
      • SSD Endoscopia digestiva - Ospedale Manerbio
  • Modena
    • Baggiovara, Modena, Italy
      • SC Gastroenterologia Endoscopia Digestiva. Ospedale di Baggiovara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male / female patients
• outpatient, consecutively subjected to colonoscopy with an exam scheduled from 8.00 to 10.00
• Age between 18 and 75 years
• Written informed consent

Exclusion Criteria:

• Hypersensitivity and contraindications to the product under study, to the active ingredients or to any of the excipients.

Known severe renal insufficiency (Glomerular Filtration Rate (eGFR) <30 ml / min / 1.73 m2)

• Presence of known chronic inflammatory bowel disease
• Previous digestive tract surgery
• Suspected gastrointestinal perforation
• History of congestive heart failure (NYHA class III or IV)
• Severe hepatic insufficiency or impairment (in the case of Child-Pugh Class C accurate verification of the patient's condition) indicated by transaminase values greater than 3 times the maximum normal value.
• Toxic colitis or toxic megacolon
• Suspected intestinal obstruction
• Patients enrolled in colorectal cancer screening programs
• Intestinal paralysis
• Documented electrolyte disturbances (Na, Cl, K, Ca or P outside normal limits)
• Recent symptomatic acute ischemic heart disease (<6 months). Acute myocardial infarction and recent unstable angina within six months antecedents.
• Participation in a clinical trial in which an investigational drug was administered within 30 days or 5 half-lives of the study drug, whichever is longer.
• Documented state of pregnancy ascertained through positive pregnancy test

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: full dose; Group A "delayed full-dose" regimen (study arm): intake of two large A sachets and 2 small B sachets from 20:30 to 22:00 the evening before the exam. Taking the remaining 2 envelopes A large e 2 small B envelopes from 10.30 pm to midnight the evening before the exam.	Drug: (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) full dose; Taking the colonoscopy preparation drug (Clensia) in a single administration; Other Names: Clensia in full dose
Other: split dose; Group B "split-dose" regimen (control arm): intake of two large A sachets and two small B sachets from 20.30 to 22:00 the evening before the exam. The remaining two large A envelopes and two small B envelopes will be taken 5 hours earlier than the time when the exam is scheduled on the same day as the exam.	Drug: (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) split dose; Taking the colonoscopy preparation drug (Clensia) in two stages of administration; Other Names: Clensia in Split dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of colonoscopies with adequate preparation	Percentage of colonoscopies with adequate preparation (according to BBPS score ≥ 2) in each colonic segment, in patient group A vs patient group B	1 day - the day of the colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantity of bubbles	Quantity of bubbles and / or foam according to IBS, in patient group A vs patient group B	1 day - the day of the colonoscopy
tollerability and compliance	Degree of acceptability, tolerability and compliance, by questionnaire, in the group of patients A vs the group of patients B	2 days - the day of the drug administration + the day of the colonoscopy

Collaborators and Investigators

• Sponsor: Societa Italiana di Endoscopia Digestiva
• Collaborators: IRCCS Azienda Ospedaliero-Universitaria di Bologna; Federico II University; Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis; Azienda Policlinico Umberto I; Presidio Ospedaliero Sant Ottone Frangipane Avellino; Ospedale di Manerbio ASST Garda; Ospedale Civile San Giovanni di Dio Crotone; Ospedale di Baggiovara Modena; Ospedale S. Jacopo Pistoia; Ospedale S. Martino Belluno
• Investigators: Study Chair: LUIGI PASQUALE, PROF, Societa Italiana di Endoscopia Digestiva

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2021
• Primary Completion (Actual): December 28, 2021
• Study Completion (Actual): December 28, 2021

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (Actual): October 6, 2022

Study Record Updates

• Last Update Posted (Actual): October 6, 2022
• Last Update Submitted That Met QC Criteria: October 4, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Dermatologic Agents; Antifoaming Agents; Emollients; Cathartics; Simethicone; Sodium sulfate
• Other Study ID Numbers: ERACLES01/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: THE STUDY IS PROMOTED BY THE ITALIAN SOCIETY OF DIGESIVE ENDOSCOPY as part of research activities for the improvement of clinical practices
• IPD Sharing Time Frame: AFTER THE STUDY END NO TIME LIMIT WAS FIXED
• IPD Sharing Access Criteria: REQUEST TO THE STUDY COORDINATOR
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No