Comparison of Different Low Volume Solutions Prior to Colonoscopy

Study Overview
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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

Official Title
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Comparison of Efficiency and Tolerance of Sodium Picosulphate/ Magnesium Citrate, Polyethylene Glycol/Ascorbate and Oral Sulfate Solution Before Colonoscopy

Conditions
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Colonoscopy

Intervention / Treatment
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* Drug: Natrium picosulfate / Magnesium citrate
* Drug: Polyethylene glycol / Ascorbic acid
* Drug: Natrium/ Kalium/ Magnesium sulfate


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SPMC-S<br>Natrium picosulfate /Magnesium citrate ( Picoprep™, oral solution) 2L in the evening before colonoscopy | Drug: Natrium picosulfate / Magnesium citrate<br>* bowel preparation formula<br>|
| Active Comparator: SPMC-D<br>Natrium picosulfate/ Magnesium citrate ( Picoprep™, oral solution) 1L in the evening and 1L in the morning before colonoscopy | Drug: Natrium picosulfate / Magnesium citrate<br>* bowel preparation formula<br>|
| Active Comparator: PEGA-S<br>Polyethylene glycol / Ascorbic acid ( Moviprep™, oral solution) 2L in the evening before colonoscopy | Drug: Polyethylene glycol / Ascorbic acid<br>* bowel preparation formula<br>|
| Active Comparator: PEGA-D<br>Polyethylene glycol / Ascorbic acid (Moviprep™, oral solution) 1L in the evening and 1L in the morning before colonoscopy | Drug: Polyethylene glycol / Ascorbic acid<br>* bowel preparation formula<br>|
| Active Comparator: SULF-S<br>Natrium/ Kalium/ Magnesium sulfate ( Eziclen™, oral solution) 1 L in the evening before colonoscopy | Drug: Natrium/ Kalium/ Magnesium sulfate<br>* bowel preparation formula<br>|
| Active Comparator: SULF-D<br>Natrium/ Kalium/ Magnesium sulfate ( Eziclen™, oral solution) 0,5 L in the evening and 0,5L in the morning before colonoscopy | Drug: Natrium/ Kalium/ Magnesium sulfate<br>* bowel preparation formula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfactory bowel preparation quality (Aronchick score 1-2) | Aronchick scale (1 -5) | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel preparation tolerance assessed by Visual Analogue Scale (VAS) | VAS scale 0-10 ( 0- the best, 10 - the worst) | one day |