clinical trial to evaluate the effectiveness of two administration schedules of CitraFleet to cleanse the colon

Randomized, multicentre, single blind study to evaluate the effectiveness of two administration schedules of CitraFleet (sodium picosulfate plus magnesium citrate) to cleanse the colon

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001620-20-DE

Enrollment

320

Registered

2013-06-21

Start date

2013-07-29

Completion date

Unknown

Last updated

2014-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleansing of colon MedDRA version: 16.1 Level: PT Classification code 10010007 Term: Colonoscopy System Organ Class: 10022891 - Investigations

Interventions

Trade Name: CitraFleet, Powder for oral solution in sachet / CitraFleet Pulver zur Herstellung einer Lösung zum Einnehmen in einem Beutel Pharmaceutical Form: Powder for oral solution in sachet INN or

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age: 18 years and older 2. men or non-pregnant women. 3. Subjects undergoing elective colonoscopy 4. Subjects who, in the opinion of the Investigator, are able and willing to follow their assigned low-residue diet and hydration regimen 5. Subjects who, in the opinion of the Investigator, are able and willing to comply with study requirements, with special emphasis on dosing instructions and diary completion. 6. Subjects who have not been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities 7. Subjects who have hand-signed and dated their informed consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 260 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: 1. Congestive heart failure or decompensated heart insufficiency 2. Gastrointestinal conditions contraindicating the administration of CitraFleet: nausea and vomiting, gastric retention, gastro-intestinal ulceration, ileus, toxic colitis, toxic megacolon, gastro-intestinal obstruction or perforation, active inflammatory bowel disease 3. Ascites 4. Acute surgical abdominal conditions such as acute appendicitis 5. Severe dehydration 6. Hypermagnesaemia 7. Rhabdomyolysis 8. Hypersensitivity to any of the ingredients of the IP 9. Ingestion of an investigational product within 1 month prior to screening 10. Severe chronic kidney disease (ie, stage >3 chronic kidney disease [CKD]) 11. Have, in the opinion of the investigator, any condition that may make them unsuitable for inclusion in the study

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the clinical effectiveness as defined by adequate bowel cleansing (excellent + good) versus inadequate bowel cleansing (fair + poor) of a split-dose administration schedule of CitraFleet (PM/AM) to the product’s currently approved SmPC regimen.;Secondary Objective: - Secondary effectiveness objectives of the study are to compare the: • Percentage of colonoscopies graded as excellent, good, fair and poor for each of the regimens • Number of adequate and inadequate bowel preparations • Percentage of colonoscopies graded as poor • Segmental residual stool assessments • Colonoscopy completion rates • Polyp detection rates - acceptability - tolerability - safety with regard to • Selected laboratory parameters • Vital signs • Adverse events (AEs) ;Primary end point(s): A superiority analysis will be performed on the ITT population. Preparations rated “excellent” and “good” will be combined to indicate an adequate bowel cleansing (clinically effective), and ratings of “fair” and “poor” will be combined to indicate an inadequate bowel preparation (clinically ineffective). A superiority model using logistical regression with factors of regimen, site, gender and age group in the model to account for any variation these factors may have on clinical effectiveness. Statistical significance between regimens will be demonstrated at a significance level of 0.05 or smaller. ;Timepoint(s) of evaluation of this end point: Visit 3 and Visit 4	—

Measure

Time frame

Main Objective: To compare the clinical effectiveness as defined by adequate bowel cleansing (excellent + good) versus inadequate bowel cleansing (fair + poor) of a split-dose administration schedule of CitraFleet (PM/AM) to the product’s currently approved SmPC regimen.;Secondary Objective: - Secondary effectiveness objectives of the study are to compare the: • Percentage of colonoscopies graded as excellent, good, fair and poor for each of the regimens • Number of adequate and inadequate bowel preparations • Percentage of colonoscopies graded as poor • Segmental residual stool assessments • Colonoscopy completion rates • Polyp detection rates - acceptability - tolerability - safety with regard to • Selected laboratory parameters • Vital signs • Adverse events (AEs) ;Primary end point(s): A superiority analysis will be performed on the ITT population. Preparations rated “excellent” and “good” will be combined to indicate an adequate bowel cleansing (clinically effective), and ratings of “fair” and “poor” will be combined to indicate an inadequate bowel preparation (clinically ineffective). A superiority model using logistical regression with factors of regimen, site, gender and age group in the model to account for any variation these factors may have on clinical effectiveness. Statistical significance between regimens will be demonstrated at a significance level of 0.05 or smaller. ;Timepoint(s) of evaluation of this end point: Visit 3 and Visit 4

—

Secondary

Measure	Time frame
Secondary end point(s): - ITT population: analysis of secondary effectiveness endpoints. Comparison of endpoints between regimens will be performed with 95% confidence intervals or P-values - ITT population: analysis of acceptability and tolerability endpoints. - Safety population: analysis of secondary safety endpoints ;Timepoint(s) of evaluation of this end point: Visit 4	—

Countries

Germany

Contacts

Public ContactAngel Callejo Mellén

Apices para Laboratorios Casen-Fleet S.L.U.

acallejo@non-casenfleet.com++34913517978

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026