Comparison of Different Low Volume Solutions Prior to Colonoscopy

Phase 4

Completed

• Conditions: Colonoscopy
• Interventions: Drug: Natrium picosulfate / Magnesium citrate; Drug: Polyethylene glycol / Ascorbic acid; Drug: Natrium/ Kalium/ Magnesium sulfate

• Registration Number: NCT03698474
• Lead Sponsor: Tomas Bata Hospital, Czech Republic

Brief Summary

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

Detailed Description

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

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-04
• Study First Submitted QC: 2018-10-04
• Study First Posted: 2018-10-09
• Study Start: 2018-10-25
• Primary Completion: 2019-02-12
• Study Completion: 2019-02-12
• Last Update Submitted: 2019-03-07
• Last Update Posted: 2019-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 612

Inclusion Criteria

• subjects referred to diagnostic or therapeutic colonoscopy

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPMC-S	Natrium picosulfate / Magnesium citrate	Natrium picosulfate /Magnesium citrate ( Picoprep™, oral solution) 2L in the evening before colonoscopy
PEGA-S	Polyethylene glycol / Ascorbic acid	Polyethylene glycol / Ascorbic acid ( Moviprep™, oral solution) 2L in the evening before colonoscopy
PEGA-D	Polyethylene glycol / Ascorbic acid	Polyethylene glycol / Ascorbic acid (Moviprep™, oral solution) 1L in the evening and 1L in the morning before colonoscopy
SULF-S	Natrium/ Kalium/ Magnesium sulfate	Natrium/ Kalium/ Magnesium sulfate ( Eziclen™, oral solution) 1 L in the evening before colonoscopy
SULF-D	Natrium/ Kalium/ Magnesium sulfate	Natrium/ Kalium/ Magnesium sulfate ( Eziclen™, oral solution) 0,5 L in the evening and 0,5L in the morning before colonoscopy
SPMC-D	Natrium picosulfate / Magnesium citrate	Natrium picosulfate/ Magnesium citrate ( Picoprep™, oral solution) 1L in the evening and 1L in the morning before colonoscopy

Primary Outcome Measures

Name	Time	Method
Satisfactory bowel preparation quality (Aronchick score 1-2)	one day	Aronchick scale (1 -5)

Secondary Outcome Measures

Name	Time	Method
Bowel preparation tolerance assessed by Visual Analogue Scale (VAS)	one day	VAS scale 0-10 ( 0- the best, 10 - the worst)

Trial Locations

Locations (1)

Faculty Hospital Kralovske Vinohrady; 🇨🇿 Prague, Czechia