Overview

Evaluation of a Mixed Bowel Prep (2L PEG + Bisacodyl) Versus PEG With Ascorbate

Status:
Completed
Trial end date:
2010-12-01
Target enrollment:
0
Participant gender:
All
Summary
It is hypothesized that PEG 2L with citrate and simeticone plus bisacodyl will have similar bowel cleansing efficacy versus PEG 2L with ascorbate. Safety, tolerability, acceptance and compliance of the two reduced volume PEG-based bowel preparation will be also compared.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Promefarm S.r.l.
Treatments:
Bisacodyl
Criteria
Inclusion Criteria:

- Out-patients undergoing a complete colonoscopy

- Patient written informed consent

Exclusion Criteria:

- Pregnant or lactating women or at a risk of becoming pregnant

- Hypersensitivity to any of the ingredients

- History of anaphylaxis to drugs or allergic reactions in general

- Known or suspected gastrointestinal obstruction or perforation

- Toxic megacolon; major colonic resection

- Heart failure (Class III or IV); severe renal failure; relevant diseases, that may
interfere with the aim of the study

- Phenylketonuria;Glucose-6-phosphate dehydrogenase deficiency

- Unwillingness to co-operate and to comply with the requirements of the trial