Comparison of Different Low Volume Solutions Prior to Colonoscopy

Tomas Bata Hospital, Czech Republic

Status and phase: Completed; Phase 4

Conditions: Colonoscopy

Treatments: Drug: Natrium picosulfate / Magnesium citrate; Drug: Polyethylene glycol / Ascorbic acid; Drug: Natrium/ Kalium/ Magnesium sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT03698474

BN102018

Details and patient eligibility

About

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

Full 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

Enrollment: 612 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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612 participants in 6 patient groups

SPMC-S

Active Comparator group

Description:

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

Treatment:

Drug: Natrium picosulfate / Magnesium citrate

SPMC-D

Active Comparator group

Description:

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

Treatment:

Drug: Natrium picosulfate / Magnesium citrate

PEGA-S

Active Comparator group

Description:

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

Treatment:

Drug: Polyethylene glycol / Ascorbic acid

PEGA-D

Active Comparator group

Description:

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

Treatment:

Drug: Polyethylene glycol / Ascorbic acid

SULF-S

Active Comparator group

Description:

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

Treatment:

Drug: Natrium/ Kalium/ Magnesium sulfate

SULF-D

Active Comparator group

Description:

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

Treatment:

Drug: Natrium/ Kalium/ Magnesium sulfate