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NCT03698474 Clinical Trial

Comparison of Different Low Volume Solutions Prior to Colonoscopy

Colonoscopy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03698474
Other study ID # BN102018
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 25, 2018
Est. completion date February 12, 2019

Study information
Verified date October 2018
Source Tomas Bata Hospital, Czech Republic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 612
Est. completion date February 12, 2019
Est. primary completion date February 12, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Natrium picosulfate / Magnesium citrate
bowel preparation formula
• Polyethylene glycol / Ascorbic acid
bowel preparation formula
• Natrium/ Kalium/ Magnesium sulfate
bowel preparation formula

Locations
Country Name City State
Czechia Faculty Hospital Kralovske Vinohrady Prague

Sponsors (2)
Lead Sponsor Collaborator
Tomas Bata Hospital, Czech Republic Faculty Hospital Kralovske Vinohrady

Country where clinical trial is conducted

Czechia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Satisfactory bowel preparation quality (Aronchick score 1-2) Aronchick scale (1 -5) one day
Secondary Bowel preparation tolerance assessed by Visual Analogue Scale (VAS) VAS scale 0-10 ( 0- the best, 10 - the worst) one day
See also
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Completed NCT00390598 - PEG Solution (Laxabon®) 4L Versus Senna Glycoside (Pursennid® Ex-Lax) 36mg and PEG Solution (Laxabon®) 2L for Large Bowel Cleansing Prior to Colonoscopy Phase 2/Phase 3
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