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Completed

NCT Number: NCT05570669

Evaluation of Two Different Regimens of Colon Preparations for Advanced Cleaning.

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Presidio Ospedaliero Sant'Ottone Frangipane, Ariano Irpino, Avellino, Italy

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

(Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) full dose

Drug

Taking the colonoscopy preparation drug (Clensia) in a single administration

Other names: Clensia in full dose

(Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) split dose

Drug

Taking the colonoscopy preparation drug (Clensia) in two stages of administration

Other names: Clensia in Split dose

Primary outcomes

  1. Percentage of colonoscopies with adequate preparation

    Time frame: 1 day - the day of the colonoscopy

    Percentage of colonoscopies with adequate preparation (according to BBPS score ≥ 2) in each colonic segment, in patient group A vs patient group B

Secondary outcomes

  1. Quantity of bubbles

    Time frame: 1 day - the day of the colonoscopy

    Quantity of bubbles and / or foam according to IBS, in patient group A vs patient group B

  2. tollerability and compliance

    Time frame: 2 days - the day of the drug administration + the day of the colonoscopy

    Degree of acceptability, tolerability and compliance, by questionnaire, in the group of patients A vs the group of patients B

Sponsors and collaborators

Lead sponsor

Societa Italiana di Endoscopia Digestiva

Other

Collaborators

  • Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
  • Azienda Policlinico Umberto I
  • Federico II University
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna
  • Ospedale Civile San Giovanni di Dio Crotone
  • Ospedale S. Jacopo Pistoia
  • Ospedale S. Martino Belluno
  • Ospedale di Baggiovara Modena
  • Ospedale di Manerbio ASST Garda
  • Presidio Ospedaliero Sant Ottone Frangipane Avellino

Registry information

Official study title

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

Acronym: ERACLES

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 6, 2022
Registry last updated
Oct 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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