Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.


Condition Intervention Phase
Subjects Undergoing a Complete Exploratory Diagnostic Colonoscopy for the First Time.
Drug: Sodium picosulphate, light magnesium oxide and anhydride citric acid.
Drug: Polyethylene glycol, KCl, NaCl, sodium sulphate anhydrous and sodium bicarbonate.
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Phase III, Multicenter, Randomized, Assessor-blind Study to Evaluate the Safety and Efficacy of CitraFleet (Sodium Picosulphate) as an Evacuating Treatment Prior to Colonoscopy.

Resource links provided by NLM:


Further study details as provided by Laboratorios Casen-Fleet S.L.U.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Frequency of adverse reactions. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 547
Study Start Date: January 2010
Study Completion Date: February 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Citrafleet
The day prior to the colonoscopy in two dose times, first at 15:00h and second at 20:00h.
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
Active Comparator: Klean Prep
The day prior to the colonoscopy from 16:00h to 20:00h.
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 Exploratory
The day of the colonoscopy in two dose times, first at 06:00h and second at 09:00h.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01065857

Locations
Spain
H. Infanta Elena
Valdemoro, Madrid, Spain, 28340
Clínica Universitaria de Navarra
Pamplona, Navarra, Spain, 31008
H. Universitario de Canarias
La Laguna, Tenerife, Spain, 38320
H. Basurto
Bilbao, Vizcaya, Spain, 48013
H. Universitari Vall´d Hebron
Barcelona, Spain, 08035
H. Clínic
Barcelona, Spain, 08036
H. General Universitario Reina Sofía
Córdoba, Spain, 14004
H. Universitario Virgen de las Nieves
Granada, Spain, 18014
H. General Universitario Gregorio Marañón
Madrid, Spain, 28007
H. Universitario Puerta de Hierro
Madrid, Spain, 28222
H. Universitario Virgen de la Arrixaca
Murcia, Spain, 30120
H. Regional Universitario Carlos Haya
Málaga, Spain, 29010
H. Universitario Central de Asturias
Oviedo, Spain, 33006
H. Virgen Macarena
Sevilla, Spain, 41009
H. Universitario La Fé
Valencia, Spain, 46009
Sponsors and Collaborators
Laboratorios Casen-Fleet S.L.U.
Trial Form Support S.L.
Apices Soluciones S.L.
Investigators
Principal Investigator: Miguel A. Muñoz-Navas, M.D. Clínica Universitaria de Navarra
  More Information

No publications provided

Responsible Party: Ángel Navarro Lima, M.D. / European Medical Affairs Director, Laboratorios Casen-Fleet S.L.U.
ClinicalTrials.gov Identifier: NCT01065857     History of Changes
Other Study ID Numbers: CF-PICOS2006
Study First Received: February 8, 2010
Last Updated: April 14, 2011
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Laboratorios Casen-Fleet S.L.U.:
Colonoscopy, Preparation, Evacuating, Bowel Cleansing.

Additional relevant MeSH terms:
Citric Acid
Magnesium Oxide
Picosulfate sodium
Sodium sulfate
Antacids
Anticoagulants
Cathartics
Chelating Agents
Gastrointestinal Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Sequestering Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014