Safety and Efficacy Study of CitraFleet (Sodium Picosulphate) as an Evacuating Treatment Prior to Colonoscopy.

This study has been completed.
Sponsor:
Collaborators:
Trial Form Support S.L.
Apices Soluciones S.L.
Information provided by:
Laboratorios Casen-Fleet S.L.U.
ClinicalTrials.gov Identifier:
NCT01065857
First received: February 8, 2010
Last updated: April 14, 2011
Last verified: April 2011

February 8, 2010
April 14, 2011
January 2010
June 2010   (final data collection date for primary outcome measure)
  • Percentage of subjects that achieve 'excellent' or 'good' cleansing in the Fleet® Grading Scale for Bowel Cleansing. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01065857 on ClinicalTrials.gov Archive Site
Frequency of adverse reactions. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

The purpose of this study is to determine any significant differences in the efficacy and acceptability between CitraFleet and Klean Prep® (polyethylene glycol) for the preparation of gastrointestinal subjects undergoing a colon examination.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Subjects Undergoing a Complete Exploratory Diagnostic Colonoscopy for the First Time.
  • Drug: Sodium picosulphate, light magnesium oxide and anhydride citric acid.
    2 Single-dose sachets containing sodium picosulphate (0.01g/sachet), light magnesium oxide (3.50g/sachet) and anhydrous citric acid (10.97g/sachet).
    Other Name: Citrafleet
  • Drug: Polyethylene glycol, KCl, NaCl, sodium sulphate anhydrous and sodium bicarbonate.
    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 Name: KleanPrep PEG 4l
  • Experimental: Citrafleet
    The day prior to the colonoscopy in two dose times, first at 15:00h and second at 20:00h.
    Intervention: Drug: Sodium picosulphate, light magnesium oxide and anhydride citric acid.
  • Active Comparator: Klean Prep
    The day prior to the colonoscopy from 16:00h to 20:00h.
    Intervention: Drug: Polyethylene glycol, KCl, NaCl, sodium sulphate anhydrous and sodium bicarbonate.
  • Experimental: Citrafleet Exploratory
    The day of the colonoscopy in two dose times, first at 06:00h and second at 09:00h.
    Intervention: Drug: Sodium picosulphate, light magnesium oxide and anhydride citric acid.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
547
February 2011
June 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01065857
CF-PICOS2006
No
Ángel Navarro Lima, M.D. / European Medical Affairs Director, Laboratorios Casen-Fleet S.L.U.
Laboratorios Casen-Fleet S.L.U.
  • Trial Form Support S.L.
  • Apices Soluciones S.L.
Principal Investigator: Miguel A. Muñoz-Navas, M.D. Clínica Universitaria de Navarra
Laboratorios Casen-Fleet S.L.U.
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP