Comparison of Different Low Volume Solutions Prior to Colonoscopy

March 7, 2019 updated by: Tomas Bata Hospital, Czech Republic

Comparison of Efficiency and Tolerance of Sodium Picosulphate/ Magnesium Citrate, Polyethylene Glycol/Ascorbate and Oral Sulfate Solution Before Colonoscopy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

612

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Prague, Czechia, 10024
        • Faculty Hospital Královské Vinohrady

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SPMC-S
Natrium picosulfate /Magnesium citrate ( Picoprep™, oral solution) 2L in the evening before colonoscopy
Drug: Natrium picosulfate / Magnesium citrate
bowel preparation formula
Active Comparator: SPMC-D
Natrium picosulfate/ Magnesium citrate ( Picoprep™, oral solution) 1L in the evening and 1L in the morning before colonoscopy
Drug: Natrium picosulfate / Magnesium citrate
bowel preparation formula
Active Comparator: PEGA-S
Polyethylene glycol / Ascorbic acid ( Moviprep™, oral solution) 2L in the evening before colonoscopy
Drug: Polyethylene glycol / Ascorbic acid
bowel preparation formula
Active Comparator: PEGA-D
Polyethylene glycol / Ascorbic acid (Moviprep™, oral solution) 1L in the evening and 1L in the morning before colonoscopy
Drug: Polyethylene glycol / Ascorbic acid
bowel preparation formula
Active Comparator: SULF-S
Natrium/ Kalium/ Magnesium sulfate ( Eziclen™, oral solution) 1 L in the evening before colonoscopy
Drug: Natrium/ Kalium/ Magnesium sulfate
bowel preparation formula
Active Comparator: SULF-D
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
bowel preparation formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfactory bowel preparation quality (Aronchick score 1-2)
Time Frame: one day
Aronchick scale (1 -5)
one day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bowel preparation tolerance assessed by Visual Analogue Scale (VAS)
Time Frame: one day
VAS scale 0-10 ( 0- the best, 10 - the worst)
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tomas Bata Hospital, Czech Republic

Collaborators

Faculty Hospital Kralovske Vinohrady

Investigators

  • Principal Investigator: Vladimir Kojecky, KNTB Zlin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2018

Primary Completion (Actual)

February 12, 2019

Study Completion (Actual)

February 12, 2019

Study Registration Dates

First Submitted

October 4, 2018

First Submitted That Met QC Criteria

October 4, 2018

First Posted (Actual)

October 9, 2018

Study Record Updates

Last Update Posted (Actual)

March 8, 2019

Last Update Submitted That Met QC Criteria

March 7, 2019

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BN102018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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