ColonoscopyPhase 4NCT02956057

Polyethylene Glycol Versus Low Volume Solutions Prior to Colonoscopy

A Phase 4 study testing Polyethylene Glycols, Natrium picosulfate / Magnesium citrate and Polyethylene glycol / Ascorbic acid in people with Colonoscopy, run by Tomas Bata Hospital, Czech Republic at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Colonoscopy
What is being tested?: Polyethylene Glycols, Natrium picosulfate / Magnesium citrate and Polyethylene glycol / Ascorbic acid
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,044 participants
Where: 1 siteCzechia
Study dates: 12 Nov 2016to 17 Aug 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects referred to diagnostic or therapeutic colonoscopy

Who cannot join

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 locations and contacts

1 site in 1 country.

Czechia1 site

Faculty Hospital Kralovske Vinohrady
Prague, 10024

Other trials in Czechia

About this study

Official title: A Head-to-head Comparison of Efficiency and Tolerance of 4-L Polyethylene Glycol and Sodium Picosulphate/ Magnesium Citrate, Polyethylene Glycol/Ascorbate Before Colonoscopy

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

Read the detailed 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.

Conditions: Colonoscopy
Being tested: Polyethylene Glycols, Natrium picosulfate / Magnesium citrate, Polyethylene glycol / Ascorbic acid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Polyethylene GlycolsDrug
Natrium picosulfate / Magnesium citrateDrug
Polyethylene glycol / Ascorbic acidDrug

Study groups in NCT02956057
Study group	Role	What they receive
PEG1D	Active comparator	Polyethylene glycols single dose a day before colonoscopy Receives: Drug: Polyethylene Glycols
PEG2D	Active comparator	Polyethylene glycols split dose Receives: Drug: Polyethylene Glycols
SPMC1D	Active comparator	Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy Receives: Drug: Natrium picosulfate / Magnesium citrate
SPMC2D	Active comparator	Natrium picosulfate/ Magnesium citrate split dose Receives: Drug: Natrium picosulfate / Magnesium citrate
PEGA1D	Active comparator	Polyethylene glycol / Ascorbic acid single dose day before colonoscopy Receives: Drug: Polyethylene glycol / Ascorbic acid
PEGA2D	Active comparator	Polyethylene glycol / Ascorbic acid split dose Receives: Drug: Polyethylene glycol / Ascorbic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: One day

Secondary outcomes (1)

Tolerance of Bowel Preparation Assessed by 5 Point VAS ( Score 1+2)
Tolerance of Bowel Preparation Assessed by VAS score 1+2 ( 1-excellent, 5-very poor)
Measured: One day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Nov 201617 Aug 2017

First posted4 Nov 2016 (estimated)
Study start12 Nov 2016
Primary completion29 May 2017
Study completion17 Aug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ColonoscopyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 1,044 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02956057
Sponsor's protocol ID: BN102016
Status last verified: Oct 2020
First submitted: 1 Nov 2016
Last updated: 28 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 28944412

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Colonoscopy trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Head-to-head Comparison of Efficiency and Tolerance of 4-L Polyethylene Glycol and Sodium Picosulphate/ Magnesium Citrate, Polyethylene Glycol/Ascorbate Before Colonoscopy
ClinicalTrials.gov ID: NCT02956057
Acronym / sponsor ID: BN102016
Conditions: Colonoscopy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,044 participants (actual)
Lead sponsor: Tomas Bata Hospital, Czech RepublicUniversity, hospital or other
Collaborators: Brno University Hospital, Faculty Hospital Kralovske Vinohrady
Study start: 12 Nov 2016 (actual)
Primary completion: 29 May 2017 (actual)
Study completion: 17 Aug 2017 (actual)
First posted: 4 Nov 2016 (estimated)
Results: Posted 28 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 6

Arm	Type	Receives
PEG1D	Active comparator	Drug: Polyethylene GlycolsPolyethylene glycols single dose a day before colonoscopy
PEG2D	Active comparator	Drug: Polyethylene GlycolsPolyethylene glycols split dose
SPMC1D	Active comparator	Drug: Natrium picosulfate / Magnesium citrateNatrium picosulfate/ Magnesium citrate single dose day before colonoscopy
SPMC2D	Active comparator	Drug: Natrium picosulfate / Magnesium citrateNatrium picosulfate/ Magnesium citrate split dose
PEGA1D	Active comparator	Drug: Polyethylene glycol / Ascorbic acidPolyethylene glycol / Ascorbic acid single dose day before colonoscopy
PEGA2D	Active comparator	Drug: Polyethylene glycol / Ascorbic acidPolyethylene glycol / Ascorbic acid split dose

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Subjects referred to diagnostic or therapeutic colonoscopy

Key exclusion criteria (7 listed)

ileus
known or suspected bowel obstruction
active bowel inflammation
pregnancy
any presence of serious medical conditions

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Polyethylene Glycols	Drug	PEG1D, PEG2D
Natrium picosulfate / Magnesium citrate	Drug	SPMC1D, SPMC2D
Polyethylene glycol / Ascorbic acid	Drug	PEGA1D, PEGA2D

Primary outcome

Quality of Bowel Preparation Using the Aronchick Scale ( Score 1+2)
Time frame: One day
Bowel preparation score 1+2 expressed on Aronchick scale (1 the best, 5 the worst)

1 secondary outcome

Tolerance of Bowel Preparation Assessed by 5 Point VAS ( Score 1+2)
Time frame: One day

Results and safety

Results posted to the registry on 28 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PEG1D	174	160
PEG2D	174	162
SPMC1D	174	166
SPMC2D	174	159
PEGA1D	174	169
PEGA2D	174	157

Primary outcome: Quality of Bowel Preparation Using the Aronchick Scale ( Score 1+2)

Time frame: One day. Count of participants. Unit: Participants

Measure	PEG1D n = 160	PEG2D n = 162	SPMC1D n = 166	SPMC2D n = 159	PEGA1D n = 169	PEGA2D n = 157
Value	110	145	100	134	121	55

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 0. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
PEG1D	0 of 0	0 of 0
PEG2D	0 of 0	0 of 0
SPMC1D	0 of 0	0 of 0
SPMC2D	0 of 0	0 of 0
PEGA1D	0 of 0	0 of 0
PEGA2D	0 of 0	0 of 0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28944412Kojecky 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vladimir Kojecky, MD principal investigator

Nemocnice T.Bati

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Bowel Preparation Using the Aronchick Scale ( Score 1+2) (time frame: One day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02956057, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.