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

Promefarm

Status and phase: Completed; Phase 4

Conditions: Colonoscopy

Treatments: Drug: 2L PEG-CS plus bisacodyl; Drug: 2L PEG-ASC

Study type: Interventional

Funder types: Industry

Identifiers

NCT01509131

PMF105BC1/09

Details and patient eligibility

About

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.

Enrollment: 408 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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408 participants in 2 patient groups

2L PEG-CS plus bisacodyl

Experimental group

Description:

Patients will be asked to take 2L PEG-CS plus bisacodyl (10-20 mg according to patient bowel habit)

Treatment:

Drug: 2L PEG-CS plus bisacodyl

2L PEG-ASC

Active Comparator group

Description:

Patients will be asked to take PEG-ASC according to labeling instructions

Treatment:

Drug: 2L PEG-ASC