Comparison of Different Low Volume Solutions Prior to Colonoscopy

NCT ID: NCT03698474

Last Updated: 2019-03-08

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

612 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-25

Study Completion Date

2019-02-12

Brief Summary

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Study evaluates the head -to-head efficacy and tolerability of low volume preparations prior to colonoscopy

Detailed Description

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Aim of the study: To compare the efficacy and tolerance of sodium picosulphate/magnesium citrate, polyethylene glycol/ascorbic acid and oral sulfate formula in a single or split dose regimen prior to colonoscopy

Conditions

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Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SPMC-S

Natrium picosulfate /Magnesium citrate ( Picoprep™, oral solution) 2L in the evening before colonoscopy

Group Type ACTIVE_COMPARATOR

Natrium picosulfate / Magnesium citrate

Intervention Type DRUG

bowel preparation formula

SPMC-D

Natrium picosulfate/ Magnesium citrate ( Picoprep™, oral solution) 1L in the evening and 1L in the morning before colonoscopy

Group Type ACTIVE_COMPARATOR

Natrium picosulfate / Magnesium citrate

Intervention Type DRUG

bowel preparation formula

PEGA-S

Polyethylene glycol / Ascorbic acid ( Moviprep™, oral solution) 2L in the evening before colonoscopy

Group Type ACTIVE_COMPARATOR

Polyethylene glycol / Ascorbic acid

Intervention Type DRUG

bowel preparation formula

PEGA-D

Polyethylene glycol / Ascorbic acid (Moviprep™, oral solution) 1L in the evening and 1L in the morning before colonoscopy

Group Type ACTIVE_COMPARATOR

Polyethylene glycol / Ascorbic acid

Intervention Type DRUG

bowel preparation formula

SULF-S

Natrium/ Kalium/ Magnesium sulfate ( Eziclen™, oral solution) 1 L in the evening before colonoscopy

Group Type ACTIVE_COMPARATOR

Natrium/ Kalium/ Magnesium sulfate

Intervention Type DRUG

bowel preparation formula

SULF-D

Natrium/ Kalium/ Magnesium sulfate ( Eziclen™, oral solution) 0,5 L in the evening and 0,5L in the morning before colonoscopy

Group Type ACTIVE_COMPARATOR

Natrium/ Kalium/ Magnesium sulfate

Intervention Type DRUG

bowel preparation formula

Interventions

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Natrium picosulfate / Magnesium citrate

bowel preparation formula

Intervention Type DRUG

Polyethylene glycol / Ascorbic acid

bowel preparation formula

Intervention Type DRUG

Natrium/ Kalium/ Magnesium sulfate

bowel preparation formula

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* subjects referred to diagnostic or therapeutic colonoscopy

Exclusion Criteria

* known or suspected bowel obstruction
* active bowel inflammation
* pregnancy
* prior bowel resection
* any presence of serious medical conditions ( cardiac, renal, liver disease)
* inability to obtain valid data from subject
* active bowel bleeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Faculty Hospital Kralovske Vinohrady

OTHER_GOV

Sponsor Role collaborator

Tomas Bata Hospital, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vladimir Kojecky

Role: PRINCIPAL_INVESTIGATOR

KNTB Zlin

Locations

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Faculty Hospital Kralovske Vinohrady

Prague, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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BN102018

Identifier Type: -

Identifier Source: org_study_id

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