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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

408 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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2L PEG-CS plus bisacodyl

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

Group Type EXPERIMENTAL

2L PEG-CS plus bisacodyl

Intervention Type DRUG

Patients will be asked to take 2L of Lovolesse and bisacodyl (10-20 mg according to patient bowel habit)

2L PEG-ASC

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

Group Type ACTIVE_COMPARATOR

2L PEG-ASC

Intervention Type DRUG

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

Interventions

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2L PEG-CS plus bisacodyl

Patients will be asked to take 2L of Lovolesse and bisacodyl (10-20 mg according to patient bowel habit)

Intervention Type DRUG

2L PEG-ASC

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

Intervention Type DRUG

Other Intervention Names

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Lovolesse 2L plus Lovoldyl 5 mg (2-4 tablets) Moviprep

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No