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

NCT01065857 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 547

Last updated 2011-04-15

No results posted yet for this study

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.

Interventions

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).

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).

Sponsors & Collaborators

  • Trial Form Support S.L.

    collaborator OTHER

  • Apices Soluciones S.L.

    collaborator INDUSTRY

  • Laboratorios Casen-Fleet S.L.U.

    lead INDUSTRY

Principal Investigators

  • Miguel A. Muñoz-Navas, M.D. · Clínica Universitaria de Navarra

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-06-30
Completion
2011-02-28

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01065857 on ClinicalTrials.gov