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

P

Promefarm S.r.l.

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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