NCT05570669

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
Last Updated

October 6, 2022

Status Verified

September 1, 2022

Enrollment Period

7 months

First QC Date

September 27, 2022

Last Update Submit

October 4, 2022

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Quantity of bubbles

    1 day - the day of the colonoscopy

  • tollerability and compliance

    2 days - the day of the drug administration + the day of the colonoscopy

Study Arms (2)

full dose

EXPERIMENTAL

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

split dose

OTHER

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

Interventions

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

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

Also known as: Clensia in full dose
full dose
(Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) split doseDRUG

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

Also known as: Clensia in Split dose
split dose

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Presidio Ospedaliero Sant'Ottone Frangipane

Ariano Irpino, Avellino, 83031, Italy

Location

Reparto di Gastroenterologia IRRCS Saverio de Bellis

Castellana Grotte, BARI, Italy

Location

SSD Endoscopia digestiva - Ospedale Manerbio

Manerbio, Brescia, Italy

Location

SC Gastroenterologia Endoscopia Digestiva. Ospedale di Baggiovara

Baggiovara, Modena, Italy

Location

SC Gastroenterologia ed Endoscopia Digestiva - Ospedale S. Martino

Belluno, Italy

Location

Dipartimento di scienze mediche e chirurgiche, Università di Bologna - Policlinico Sant'Orsola

Bologna, Italy

Location

Reparto Gastroenterologia ed Endoscopia dell'Ospedale Civile San Giovanni di Dio

Crotone, Italy

Location

Servizio Centralizzato di Endoscopia Digestiva Operatoria - AOU Federico II

Napoli, Italy

Location

S.S. Endoscopia Digestiva/ P.O. S. Jacopo

Pistoia, Italy

Location

Chirurgia Generale AOU Policlinico Umberto I

Rome, Italy

Location

MeSH Terms

Interventions

Polyethylene Glycols

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • LUIGI PASQUALE, PROF

    Societa Italiana di Endoscopia Digestiva

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
the endoscopist analyzes the results and evaluates the cleaning without knowing the treatment followed by the patient
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: two groups randomized 1:1
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2022

First Posted

October 6, 2022

Study Start

May 25, 2021

Primary Completion

December 28, 2021

Study Completion

December 28, 2021

Last Updated

October 6, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

THE STUDY IS PROMOTED BY THE ITALIAN SOCIETY OF DIGESIVE ENDOSCOPY as part of research activities for the improvement of clinical practices

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
AFTER THE STUDY END NO TIME LIMIT WAS FIXED
Access Criteria
REQUEST TO THE STUDY COORDINATOR

Locations

IT(10)