ColonoscopyPhase 4ERACLESNCT05570669
Evaluation of Two Different Regimens of Colon Preparations for Advanced Cleaning.
A Phase 4 study testing (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) full dose and (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) split dose in people with Colonoscopy, run by Societa Italiana di Endoscopia Digestiva at 10 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colonoscopy
- What is being tested?
- (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) full dose and (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) split dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 321 participants
- Where
- 10 sitesItaly
- Study dates
- 25 May 2021to 28 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Italy10 sites
Presidio Ospedaliero Sant'Ottone Frangipane
Ariano Irpino, Avellino, 83031
SC Gastroenterologia Endoscopia Digestiva. Ospedale di Baggiovara
Baggiovara, Modena
SC Gastroenterologia ed Endoscopia Digestiva - Ospedale S. Martino
Belluno
Dipartimento di scienze mediche e chirurgiche, Università di Bologna - Policlinico Sant'Orsola
Bologna
Reparto di Gastroenterologia IRRCS Saverio de Bellis
Castellana Grotte, BARI
Reparto Gastroenterologia ed Endoscopia dell'Ospedale Civile San Giovanni di Dio
Crotone
SSD Endoscopia digestiva - Ospedale Manerbio
Manerbio, Brescia
Servizio Centralizzato di Endoscopia Digestiva Operatoria - AOU Federico II
Naples
S.S. Endoscopia Digestiva/ P.O. S. Jacopo
Pistoia
Chirurgia Generale AOU Policlinico Umberto I
Rome
About this study
Official title: 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.
Read the 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).
- Conditions
- Colonoscopy
- Being tested
- (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) full dose, (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) split dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) full doseDrug
Also called Clensia in full dose
Taking the colonoscopy preparation drug (Clensia) in a single administration
(Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) split doseDrug
Also called Clensia in Split dose
Taking the colonoscopy preparation drug (Clensia) in two stages of administration
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) split dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day - the day of the colonoscopy
Secondary outcomes (2)
Quantity of bubbles
Quantity of bubbles and / or foam according to IBS, in patient group A vs patient group B
Measured: 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
Measured: 2 days - the day of the drug administration + the day of the colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start25 May 2021
- Primary completion28 Dec 2021
- Study completion28 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups randomized 1:1
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Societa Italiana di Endoscopia Digestiva
- Sponsor type
- University, hospital or other
- Collaborators
- Presidio Ospedaliero Sant Ottone Frangipane Avellino, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis, Azienda Policlinico Umberto I, Ospedale di Manerbio ASST Garda, Ospedale Civile San Giovanni di Dio Crotone, Ospedale di Baggiovara Modena, Ospedale S. Jacopo Pistoia, Ospedale S. Martino Belluno, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Federico II University
- Responsible party
- Sponsor
- Investigators
- LUIGI PASQUALE, PROF, Study chair, Societa Italiana di Endoscopia Digestiva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570669
- Sponsor's protocol ID
- ERACLES01/2020
- Acronym
- ERACLES
- Status last verified
- Sep 2022
- First submitted
- 27 Sep 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: THE STUDY IS PROMOTED BY THE ITALIAN SOCIETY OF DIGESIVE ENDOSCOPY as part of research activities for the improvement of clinical practices
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Different Regimens of Colon Preparations for Advanced Cleaning Using a 2lt PEG-CS With Simethicone: a Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT05570669
- Acronym / sponsor ID
- ERACLES / ERACLES01/2020
- Conditions
- Colonoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Societa Italiana di Endoscopia DigestivaUniversity, hospital or other
- Collaborators
- Presidio Ospedaliero Sant Ottone Frangipane Avellino, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis, Azienda Policlinico Umberto I, Ospedale di Manerbio ASST Garda, Ospedale Civile San Giovanni di Dio Crotone, Ospedale di Baggiovara Modena, Ospedale S. Jacopo Pistoia, Ospedale S. Martino Belluno, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Federico II University
- Study start
- 25 May 2021 (actual)
- Primary completion
- 28 Dec 2021 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- two groups randomized 1:1
| Arm | Type | Receives |
|---|---|---|
| full dose | Experimental | Drug: (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) full doseGroup 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. |
| split dose | Other | Drug: (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) split doseGroup 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) full doseAlso: Clensia in full doseTaking the colonoscopy preparation drug (Clensia) in a single administration | Drug | full dose |
| (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) split doseAlso: Clensia in Split doseTaking the colonoscopy preparation drug (Clensia) in two stages of administration | Drug | split dose |
Primary outcome
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
2 secondary outcomes
Quantity of bubbles
Time frame: 1 day - the day of the colonoscopy
tollerability and compliance
Time frame: 2 days - the day of the drug administration + the day of the colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Individual participant dataSharing planned: Yes. THE STUDY IS PROMOTED BY THE ITALIAN SOCIETY OF DIGESIVE ENDOSCOPY as part of research activities for the improvement of clinical practices
Related trials for Colonoscopy
Not yet recruiting
Effect of Box Breathing Exercise on Anxiety, Pain, and Pulmonary Function Tests in Patients Undergoing Colonoscopy
Colonoscopy
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Not yet recruiting
HFNC vs Conventional Oxygen During Gastrocolonoscopy in Elderly Patients
Hypoxemia, Eldery People
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Recruiting
Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
The Effect of Audio-visual Aids on Bowel Cleanliness, Audiovisual Aids
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LUIGI PASQUALE, PROF study chair
Societa Italiana di Endoscopia Digestiva
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) full dose and (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) split dose in people with Colonoscopy, run by Societa Italiana di Endoscopia Digestiva at 10 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of colonoscopies with adequate preparation (time frame: 1 day - the day of the colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.