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

NCT ID: NCT01065857

Last Updated: 2011-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 547 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-02-28

Brief 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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

Citrafleet

The day prior to the colonoscopy in two dose times, first at 15:00h and second at 20:00h.

Group Type: EXPERIMENTAL

Sodium picosulphate, light magnesium oxide and anhydride citric acid.

Intervention Type: DRUG

2 Single-dose sachets containing sodium picosulphate (0.01g/sachet), light magnesium oxide (3.50g/sachet) and anhydrous citric acid (10.97g/sachet).

Klean Prep

The day prior to the colonoscopy from 16:00h to 20:00h.

Group Type: ACTIVE_COMPARATOR

Polyethylene glycol, KCl, NaCl, sodium sulphate anhydrous and sodium bicarbonate.

Intervention Type: DRUG

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).

Citrafleet Exploratory

The day of the colonoscopy in two dose times, first at 06:00h and second at 09:00h.

Group Type: EXPERIMENTAL

Sodium picosulphate, light magnesium oxide and anhydride citric acid.

Intervention Type: DRUG

2 Single-dose sachets containing sodium picosulphate (0.01g/sachet), light magnesium oxide (3.50g/sachet) and anhydrous citric acid (10.97g/sachet).

Interventions

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).

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

Citrafleet; KleanPrep PEG 4l

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Trial Form Support S.L.

OTHER

Sponsor Role: collaborator

Apices Soluciones S.L.

INDUSTRY

Sponsor Role: collaborator

Laboratorios Casen-Fleet S.L.U.

INDUSTRY

Sponsor Role: lead

Responsible Party

Laboratorios Casen-Fleet S.L.U.

Principal Investigators

Miguel A. Muñoz-Navas, M.D.

Role: PRINCIPAL_INVESTIGATOR

Clínica Universitaria de Navarra

Locations

H. Universitari Vall´d Hebron

Barcelona, Barcelona, Spain

H. Clínic

Barcelona, Barcelona, Spain

H. General Universitario Reina Sofía

Córdoba, Córdoba, Spain

H. Universitario Virgen de las Nieves

Granada, Granada, Spain

H. General Universitario Gregorio Marañón

Madrid, Madrid, Spain

H. Universitario Puerta de Hierro

Madrid, Madrid, Spain

H. Infanta Elena

Valdemoro, Madrid, Spain

H. Universitario Virgen de la Arrixaca

Murcia, Murcia, Spain

H. Regional Universitario Carlos Haya

Málaga, Málaga, Spain

Clínica Universitaria de Navarra

Pamplona, Navarre, Spain

H. Universitario Central de Asturias

Oviedo, Oviedo, Spain

H. Virgen Macarena

Seville, Sevilla, Spain

H. Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, Spain

H. Universitario La Fé

Valencia, Valencia, Spain

H. Basurto

Bilbao, Vizcaya, Spain

Countries

Spain

Other Identifiers

CF-PICOS2006

Identifier Type: -

Identifier Source: org_study_id