NCT03698474

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
612

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
16 days until next milestone

Study Start

First participant enrolled

October 25, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2019

Completed
Last Updated

March 8, 2019

Status Verified

October 1, 2018

Enrollment Period

4 months

First QC Date

October 4, 2018

Last Update Submit

March 7, 2019

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

  • Satisfactory bowel preparation quality (Aronchick score 1-2)

    Aronchick scale (1 -5)

    one day

Secondary Outcomes (1)

  • Bowel preparation tolerance assessed by Visual Analogue Scale (VAS)

    one day

Study Arms (6)

SPMC-S

ACTIVE COMPARATOR

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

Drug: Natrium picosulfate / Magnesium citrate

SPMC-D

ACTIVE COMPARATOR

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

Drug: Natrium picosulfate / Magnesium citrate

PEGA-S

ACTIVE COMPARATOR

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

Drug: Polyethylene glycol / Ascorbic acid

PEGA-D

ACTIVE COMPARATOR

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

Drug: Polyethylene glycol / Ascorbic acid

SULF-S

ACTIVE COMPARATOR

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

Drug: Natrium/ Kalium/ Magnesium sulfate

SULF-D

ACTIVE COMPARATOR

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

Interventions

Natrium picosulfate / Magnesium citrateDRUG

bowel preparation formula

SPMC-DSPMC-S
Polyethylene glycol / Ascorbic acidDRUG

bowel preparation formula

PEGA-DPEGA-S
Natrium/ Kalium/ Magnesium sulfateDRUG

bowel preparation formula

SULF-DSULF-S

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subjects referred to diagnostic or therapeutic colonoscopy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty Hospital Kralovske Vinohrady

Prague, 10024, Czechia

Location

MeSH Terms

Interventions

magnesium citratePolyethylene GlycolsAscorbic AcidPotassium, DietaryMagnesium Sulfate

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureSugar AcidsAcids, AcyclicCarboxylic AcidsHydroxy AcidsCarbohydratesPotassium CompoundsInorganic ChemicalsMagnesium CompoundsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Vladimir Kojecky

    KNTB Zlin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2018

First Posted

October 9, 2018

Study Start

October 25, 2018

Primary Completion

February 12, 2019

Study Completion

February 12, 2019

Last Updated

March 8, 2019

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)