NCT02956057

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,044

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2016

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

November 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

November 12, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2017

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

October 28, 2020

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

7 months

First QC Date

November 1, 2016

Results QC Date

October 6, 2019

Last Update Submit

October 6, 2020

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

  • Quality of Bowel Preparation Using the Aronchick Scale ( Score 1+2)

    Bowel preparation score 1+2 expressed on Aronchick scale (1 the best, 5 the worst)

    One day

Secondary Outcomes (1)

  • Tolerance of Bowel Preparation Assessed by 5 Point VAS ( Score 1+2)

    One day

Study Arms (6)

PEG1D

ACTIVE COMPARATOR

Polyethylene glycols single dose a day before colonoscopy

Drug: Polyethylene Glycols

PEG2D

ACTIVE COMPARATOR

Polyethylene glycols split dose

Drug: Polyethylene Glycols

SPMC1D

ACTIVE COMPARATOR

Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy

Drug: Natrium picosulfate / Magnesium citrate

SPMC2D

ACTIVE COMPARATOR

Natrium picosulfate/ Magnesium citrate split dose

Drug: Natrium picosulfate / Magnesium citrate

PEGA1D

ACTIVE COMPARATOR

Polyethylene glycol / Ascorbic acid single dose day before colonoscopy

Drug: Polyethylene glycol / Ascorbic acid

PEGA2D

ACTIVE COMPARATOR

Polyethylene glycol / Ascorbic acid split dose

Drug: Polyethylene glycol / Ascorbic acid

Interventions

Polyethylene GlycolsDRUG
PEG1DPEG2D
Natrium picosulfate / Magnesium citrateDRUG
SPMC1DSPMC2D
Polyethylene glycol / Ascorbic acidDRUG
PEGA1DPEGA2D

Eligibility Criteria

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

You may qualify if:

  • Subjects referred to diagnostic or therapeutic colonoscopy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty Hospital Kralovske Vinohrady

Prague, 10024, Czechia

Location

Related Publications (1)

  • Kojecky V, Matous J, Keil R, Dastych M, Kroupa R, Zadorova Z, Varga M, Dolina J, Kment M, Hep A. A head-to-head comparison of 4-L polyethylene glycol and low-volume solutions before colonoscopy: which is the best? A multicentre, randomized trial. Int J Colorectal Dis. 2017 Dec;32(12):1763-1766. doi: 10.1007/s00384-017-2901-x. Epub 2017 Sep 24.

    PMID: 28944412BACKGROUND

MeSH Terms

Interventions

Polyethylene Glycolsmagnesium citrateAscorbic Acid

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureSugar AcidsAcids, AcyclicCarboxylic AcidsHydroxy AcidsCarbohydrates

Results Point of Contact

Title
Kojecky Vladimir
Organization
Tomas Bata Hospital
kojecky@bnzlin.cz
+420577552512

Study Officials

  • Vladimir Kojecky, MD

    Nemocnice T.Bati

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MUDr.

Study Record Dates

First Submitted

November 1, 2016

First Posted

November 4, 2016

Study Start

November 12, 2016

Primary Completion

May 29, 2017

Study Completion

August 17, 2017

Last Updated

October 28, 2020

Results First Posted

October 28, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)