Clinical Trials Logo

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
  Status Clinical Trial Phase
Completed NCT04101097 - Training and Validation of Models of Factors to Predict Inadequate Bowel Preparation Colonoscopy
Completed NCT03247595 - Testing How Well Magnesium Citrate Capsules Work as Preparation for a Colonoscopy N/A
Completed NCT04214301 - An Open-Label Preference Evaluation of BLI800 Phase 4
Withdrawn NCT05754255 - Comparison of High-flow Oxygen With or Without Nasal Positive Airway Pressure (PAP) During Propofol Sedation for Colonoscopy in an Ambulatory Surgical Center N/A
Recruiting NCT02484105 - Comforting Conversation During Colonoscopy: A Trial on Patient Satisfaction Phase 4
Active, not recruiting NCT02264249 - Residual Gastric Volume in Same Day Versus Split Dose and Evening Before Bowel Preparation N/A
Completed NCT01964417 - The Comparative Study Between Bowel Preparation Method Phase 3
Terminated NCT01978509 - The Affect of Low-Volume Bowel Preparation for Hospitalized Patients Colonoscopies N/A
Recruiting NCT01685970 - Comparison of Same-day 2 Sachets Picosulfate Versus High Volume PEG for Afternoon Colonoscopy Phase 3
Completed NCT01518790 - Short Course, Single-dose PEG 3350 for Colonoscopy Prep in Children N/A
Recruiting NCT00748293 - Achievement of Better Examinee Compliance on Colon Cleansing Using Commercialized Low-Residue Diet N/A
Completed NCT00779649 - MoviPrep® Versus HalfLytely®, Low-VolUme PEG Solutions for Colon Cleansing: An InvesTigator-blindEd, Randomized, Trial Phase 4
Completed NCT00671177 - Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique N/A
Completed NCT00380497 - Pico-Salax Versus Poly-Ethylene Glycol for Bowel Cleanout Before Colonoscopy in Children Phase 4
Recruiting NCT00160823 - Impact of a Self-Administered Information Leaflet on Adequacy of Colonic Cleansing for in-Hospital Patients Phase 3
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
Completed NCT00314418 - Patient Position and Impact on Colonoscopy Time N/A
Completed NCT00427089 - Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening Phase 3
Completed NCT00209573 - A Study of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Elective Colonoscopy Phase 3
Completed NCT05823350 - The Effect of Abdominal Massage on Pain and Distention After Colonoscopy N/A