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

NCT01065857 | Completed Phase 3

• 1 other identifier: CF-PICOS2006
• Study Type: interventional
• Target: 547
• Locations: 1 country
• Sites: 15

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.

Conditions

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

Keywords

Colonoscopy, Preparation, Evacuating, Bowel Cleansing.

Outcome Measures

Primary Outcomes (2)

• Percentage of subjects that achieve 'excellent' or 'good' cleansing in the Fleet® Grading Scale for Bowel Cleansing.

  24 hours

• 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

Secondary Outcomes (1)

• Frequency of adverse reactions.

  24 hours

Study Arms (3)

Citrafleet

EXPERIMENTAL

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.

Klean Prep

ACTIVE COMPARATOR

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

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

Citrafleet Exploratory

EXPERIMENTAL

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.

Interventions

Sodium picosulphate, light magnesium oxide and anhydride citric acid. DRUG

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

Also known as: Citrafleet

Citrafleet; Citrafleet Exploratory

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

Also known as: KleanPrep PEG 4l

Klean Prep

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratorios Casen-Fleet S.L.U.: lead
• Trial Form Support S.L.: collaborator
• Apices Soluciones S.L.: collaborator

Study Sites (15)

H. Universitari Vall´d Hebron

Barcelona, Barcelona, 08035, Spain

Location

H. Clínic

Barcelona, Barcelona, 08036, Spain

Location

H. General Universitario Reina Sofía

Córdoba, Córdoba, 14004, Spain

Location

H. Universitario Virgen de las Nieves

Granada, Granada, 18014, Spain

Location

H. General Universitario Gregorio Marañón

Madrid, Madrid, 28007, Spain

Location

H. Universitario Puerta de Hierro

Madrid, Madrid, 28222, Spain

Location

H. Infanta Elena

Valdemoro, Madrid, 28340, Spain

Location

H. Universitario Virgen de la Arrixaca

Murcia, Murcia, 30120, Spain

Location

H. Regional Universitario Carlos Haya

Málaga, Málaga, 29010, Spain

Location

Clínica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

Location

H. Universitario Central de Asturias

Oviedo, Oviedo, 33006, Spain

Location

H. Virgen Macarena

Seville, Sevilla, 41009, Spain

Location

H. Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, 38320, Spain

Location

H. Universitario La Fé

Valencia, Valencia, 46009, Spain

Location

H. Basurto

Bilbao, Vizcaya, 48013, Spain

Location

MeSH Terms

Interventions

picosulfate sodium; Polyethylene Glycols; Sodium Bicarbonate

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Officials

• Miguel A. Muñoz-Navas, M.D.

  Clínica Universitaria de Navarra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: February 9, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: February 1, 2011
• Last Updated: April 15, 2011

Record last verified: 2011-04

Locations

ES (15)