- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01065857
Safety and Efficacy Study of CitraFleet (Sodium Picosulphate) as an Evacuating Treatment Prior to Colonoscopy.
Phase III, Multicenter, Randomized, Assessor-blind Study to Evaluate the Safety and Efficacy of CitraFleet (Sodium Picosulphate) as an Evacuating Treatment Prior to Colonoscopy.
Study Overview
Status
Detailed Description
The composite principal objective of the current study will therefore be, to determine any significant differences in the joint variable of efficacy and acceptability between CitraFleet and Klean Prep® (polyethylene glycol) for the preparation of subjects undergoing a colon examination.
The evaluation will be carried out by two blinded assessors, independent of the investigator who performed the procedure (endoscopist investigator). It will be assessed from images of different sections of the colon: cecum, ascending, transverse, descending and rectum and subsequent confirmation by Principal Investigator if an agreement has been reached between the two blinded assessors or whether it is necessary to reach consensus.
The evaluation of the subject's acceptability will be assessed using a 5 point scale which assesses the difficulty of taking the product, the degree of discomfort caused by it, and the taste of the drug.
The secondary objective is to evaluate the safety of CitraFleet.
In addition a second exploratory arm of CitraFleet was included in this study (CitraFleet Exploratory arm). The study is not powered to make formal statistical comparisons for this arm. Exploratory assessment of this arm against the main CitraFleet regimen and Klean-Prep will be made in order to run future trials design with this schedule.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Barcelona, Spain, 08035
- H. Universitari Vall´d Hebron
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Barcelona, Spain, 08036
- H. Clinic
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Córdoba, Spain, 14004
- H. General Universitario Reina Sofía
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Granada, Spain, 18014
- H. Universitario Virgen de las Nieves
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Madrid, Spain, 28007
- H. General Universitario Gregorio Marañón
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Madrid, Spain, 28222
- H. Universitario Puerta de Hierro
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Murcia, Spain, 30120
- H. Universitario Virgen de la Arrixaca
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Málaga, Spain, 29010
- H. Regional Universitario Carlos Haya
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Oviedo, Spain, 33006
- H. Universitario Central de Asturias
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Sevilla, Spain, 41009
- H. Virgen Macarena
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Valencia, Spain, 46009
- H. Universitario la Fe
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Madrid
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Valdemoro, Madrid, Spain, 28340
- H. Infanta Elena
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Navarra
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Pamplona, Navarra, Spain, 31008
- Clinica Universitaria de Navarra
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Tenerife
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La Laguna, Tenerife, Spain, 38320
- H. Universitario de Canarias
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Vizcaya
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Bilbao, Vizcaya, Spain, 48013
- H. Basurto
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects who are between 18 and 80 years of age.
- Subjects undergoing complete colonoscopy and therefore require prior preparation with either Klean Prep® or CitraFleet.
- Subjects capable of maintaining appropriate oral hydration during the intestinal preparation process.
- Subjects that have provided written informed consent.
- Subjects in whom the use of any of the study drugs (KleanPrep®,CitraFleet) is not contraindicated.
- Subjects who can communicate with the study personnel and comply with study requirements.
- Subjects undergoing a complete exploratory diagnostic colonoscopy for the first time.
Exclusion Criteria:
- Severe renal insufficiency.
- Ascites.
- Congestive heart failure.
- Gastrointestinal obstruction, gastric retention, intestinal perforation and/or ileus.
- Megacolon and/or toxic colitis.
- Nausea and/or vomiting and/or abdominal pain.
- Severe dehydration.
- Hypermagnesemia.
- Rhabdomyolysis.
- Pregnant women.
- Subjects who have participated in a clinical trial in the previous 30 days.
- Abdominal surgery for any acute process (for example acute appendicitis).
- Active inflammatory intestinal disease.
- Known allergy to any of the active ingredients or excipients of the study drugs.
- Subjects not providing written informed consent.
- Subjects not complying with all of the inclusion criteria.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Citrafleet
The day prior to the colonoscopy in two dose times, first at 15:00h and second at 20:00h.
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2 Single-dose sachets containing sodium picosulphate (0.01g/sachet), light magnesium oxide (3.50g/sachet) and anhydrous citric acid (10.97g/sachet).
Other Names:
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Active Comparator: Klean Prep
The day prior to the colonoscopy from 16:00h to 20:00h.
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4 sachets containing Polyethylene glycol 3350 (59 gr), KCl (0.7425 gr), NaCl (1.465 gr), sodium sulphate anhydrous (5.685 gr), sodium bicarbonate (1.685 gr).
Other Names:
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Experimental: Citrafleet Exploratory
The day of the colonoscopy in two dose times, first at 06:00h and second at 09:00h.
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2 Single-dose sachets containing sodium picosulphate (0.01g/sachet), light magnesium oxide (3.50g/sachet) and anhydrous citric acid (10.97g/sachet).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of subjects that achieve 'excellent' or 'good' cleansing in the Fleet® Grading Scale for Bowel Cleansing.
Time Frame: 24 hours
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24 hours
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Percentage of subjects who find the agent easy to take or tolerable using a 5 point scale which assesses, the difficulty of taking the product, the degree of discomfort caused by it, and the taste of the drug, recorded in the subject questionnaire
Time Frame: 24 hours
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24 hours
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Frequency of adverse reactions.
Time Frame: 24 hours
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24 hours
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Miguel A. Muñoz-Navas, M.D., Clinica Universitaria de Navarra
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CF-PICOS2006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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