Polyethylene Glycol Versus Low Volume Solutions Prior to Colonoscopy

Tomas Bata Hospital, Czech Republic

Status and phase: Completed; Phase 4

Conditions: Colonoscopy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02956057

BN102016

Details and patient eligibility

About

Study evaluates the efficacy and tolerability of low volume preparations compared with conventional 4L polyethylene glycol prior to colonoscopy

Full description

To compare the efficacy and tolerance of standard polyethylene glycol to low volume sodium picosulphate/magnesium citrate and polyethylene glycol/ascorbic acid in a single or split dose regimen for colonoscopy bowel preparation in a head-to-head design.

Enrollment: 1,044 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects referred to diagnostic or therapeutic colonoscopy

Exclusion criteria

• ileus
• known or suspected bowel obstruction
• active bowel inflammation
• pregnancy
• any presence of serious medical conditions
• history of prior colonic or rectal surgery
• inability to obtain valid data from subject

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,044 participants in 6 patient groups

PEG1D

Active Comparator group

Description:

Polyethylene glycols single dose a day before colonoscopy

Treatment:

Drug: Polyethylene Glycols

PEG2D

Active Comparator group

Description:

Polyethylene glycols split dose

Treatment:

Drug: Polyethylene Glycols

SPMC1D

Active Comparator group

Description:

Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy

Treatment:

Drug: Natrium picosulfate / Magnesium citrate

SPMC2D

Active Comparator group

Description:

Natrium picosulfate/ Magnesium citrate split dose

Treatment:

Drug: Natrium picosulfate / Magnesium citrate

PEGA1D

Active Comparator group

Description:

Polyethylene glycol / Ascorbic acid single dose day before colonoscopy

Treatment:

Drug: Polyethylene glycol / Ascorbic acid

PEGA2D

Active Comparator group

Description:

Polyethylene glycol / Ascorbic acid split dose

Treatment:

Drug: Polyethylene glycol / Ascorbic acid