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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

321 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-25

Study Completion Date

2021-12-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Oral Simethicone With Low Volume Polyethylene Glycol Bowel Preparation During Colonoscopy

NCT03410524

Colonoscopy

COMPLETED PHASE3

Evaluation of a Mixed Bowel Prep (2L PEG + Bisacodyl) Versus PEG With Ascorbate

NCT01509131

Colonoscopy

COMPLETED PHASE4

Effect and Safety of Polyethylene Glycol Combined With Linaclotide on Colon Cleansing for Patients With Chronic Constipation

NCT05137145

Bowel Preparation

UNKNOWN NA

Efficacy and Tolerability of Suprep With and Without Simethicone for Routine Colonoscopy for Colorectal Cancer Screening

NCT02523911

Colorectal Cancer

WITHDRAWN NA

Comparison of Bowel Cleansing Regimens Prior to Colonoscopy

NCT01649674

Patients Undergoing Elective Colonoscopy

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colonoscopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two groups randomized 1:1

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

the endoscopist analyzes the results and evaluates the cleaning without knowing the treatment followed by the patient

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

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.

Group Type OTHER

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

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

(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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Clensia in full dose Clensia in Split dose

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No