Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Polyethylene Glycol Versus Low Volume Solutions Prior to Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02956057
Recruitment Status : Completed
First Posted : November 4, 2016
Last Update Posted : October 13, 2017
Sponsor:
Collaborators:
Brno University Hospital
Faculty Hospital Kralovske Vinohrady
Information provided by (Responsible Party):
Vladimir Kojecky, MD, Ph.D., Tomas Bata Hospital, Czech Republic

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

Condition or disease Intervention/treatment Phase
Colonoscopy Drug: Polyethylene Glycols Drug: Natrium picosulfate / Magnesium citrate Drug: Polyethylene glycol / Ascorbic acid Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1044 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : August 2017


Arm Intervention/treatment
Active Comparator: PEG1D
Polyethylene glycols single dose a day before colonoscopy
Drug: Polyethylene Glycols
Active Comparator: PEG2D
Polyethylene glycols split dose
Drug: Polyethylene Glycols
Active Comparator: SPMC1D
Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy
Drug: Natrium picosulfate / Magnesium citrate
Active Comparator: SPMC2D
Natrium picosulfate/ Magnesium citrate split dose
Drug: Natrium picosulfate / Magnesium citrate
Active Comparator: PEGA1D
Polyethylene glycol / Ascorbic acid single dose day before colonoscopy
Drug: Polyethylene glycol / Ascorbic acid
Active Comparator: PEGA2D
Polyethylene glycol / Ascorbic acid split dose
Drug: Polyethylene glycol / Ascorbic acid



Primary Outcome Measures :
  1. Quality of bowel preparation using the Aronchick scale ( score 1+2) [ Time Frame: One day ]

Secondary Outcome Measures :
  1. Tolerance of bowel preparation assessed by 5 point VAS ( score 1+2) [ Time Frame: One day ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects referred to diagnostic or therapeutic colonoscopy

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956057


Locations
Layout table for location information
Czechia
Faculty Hospital Kralovske Vinohrady
Prague, Czechia, 10024
Sponsors and Collaborators
Tomas Bata Hospital, Czech Republic
Brno University Hospital
Faculty Hospital Kralovske Vinohrady
Investigators
Layout table for investigator information
Principal Investigator: Vladimir Kojecky, MD Nemocnice T.Bati

Publications:
Layout table for additonal information
Responsible Party: Vladimir Kojecky, MD, Ph.D., MUDr., Tomas Bata Hospital, Czech Republic
ClinicalTrials.gov Identifier: NCT02956057    
Other Study ID Numbers: BN102016
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Ascorbic Acid
Magnesium citrate
Picosulfate sodium
Citric Acid
Sodium Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Antioxidants
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances
Cathartics
Gastrointestinal Agents