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

Subjects Undergoing a Complete Exploratory Diagnostic Colonoscopy for the First Time. Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01065857
• Other study ID #: CF-PICOS2006
• Status: Completed
• Phase: Phase 3
• First received: February 8, 2010
• Last updated: April 14, 2011
• Start date: January 2010
• Est. completion date: February 2011

Study information

• Verified date: April 2011
• Source: Laboratorios Casen-Fleet S.L.U.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 547
• Est. completion date: February 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Subjects Undergoing a Complete Exploratory Diagnostic Colonoscopy for the First Time.

Intervention

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).
• 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).

Locations

Country	Name	City	State
Spain	H. Clínic	Barcelona
Spain	H. Universitari Vall´d Hebron	Barcelona
Spain	H. Basurto	Bilbao	Vizcaya
Spain	H. General Universitario Reina Sofía	Córdoba
Spain	H. Universitario Virgen de las Nieves	Granada
Spain	H. Universitario de Canarias	La Laguna	Tenerife
Spain	H. General Universitario Gregorio Marañón	Madrid
Spain	H. Universitario Puerta de Hierro	Madrid
Spain	H. Regional Universitario Carlos Haya	Málaga
Spain	H. Universitario Virgen de la Arrixaca	Murcia
Spain	H. Universitario Central de Asturias	Oviedo
Spain	Clínica Universitaria de Navarra	Pamplona	Navarra
Spain	H. Virgen Macarena	Sevilla
Spain	H. Infanta Elena	Valdemoro	Madrid
Spain	H. Universitario La Fé	Valencia

Sponsors (3)

Lead Sponsor	Collaborator
Laboratorios Casen-Fleet S.L.U.	Apices Soluciones S.L., Trial Form Support S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects that achieve 'excellent' or 'good' cleansing in the Fleet® Grading Scale for Bowel Cleansing.		24 hours	No
Primary	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		24 hours	No
Secondary	Frequency of adverse reactions.		24 hours	Yes