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

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratorios Casen-Fleet S.L.U.
• Collaborators: Apices Soluciones S.L.; Trial Form Support S.L.
• Treatments: Citric Acid; Magnesium Oxide; Picosulfate sodium; Sodium Citrate; Sodium sulfate

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.