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Polyethylene Glycol Versus Low Volume Solutions Prior to Colonoscopy
This study is not yet open for participant recruitment.
Verified November 2016 by Vladimir Kojecky, MD, Ph.D., Tomas Bata Hospital, Czech Republic
Sponsor:
Tomas Bata Hospital, Czech Republic
Collaborators:
Brno University Hospital
Faculty Hospital Kralovske Vinohrady
Information provided by (Responsible Party):
Vladimir Kojecky, MD, Ph.D., Tomas Bata Hospital, Czech Republic
ClinicalTrials.gov Identifier:
NCT02956057
First received: November 1, 2016
Last updated: November 3, 2016
Last verified: November 2016
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Purpose
Study evaluates the efficacy and tolerability of low volume preparations compared with conventional 4L polyethylene glycol prior to colonoscopy
| Condition | Intervention | Phase |
|---|---|---|
| Colonoscopy | Drug: Polyethylene Glycols Drug: Natrium picosulfate / Magnesium citrate Drug: Polyethylene glycol / Ascorbic acid | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (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 |
Resource links provided by NLM:
Further study details as provided by Vladimir Kojecky, MD, Ph.D., Tomas Bata Hospital, Czech Republic:
Primary Outcome Measures:
- Quality of bowel preparation using the Aronchick scale ( score 1+2) [ Time Frame: One day ]
Secondary Outcome Measures:
- Tolerance of bowel preparation assessed by 5 point VAS ( score 1+2) [ Time Frame: One day ]
| Estimated Enrollment: | 840 |
| Study Start Date: | November 2016 |
| Estimated Study Completion Date: | May 2017 |
| Estimated Primary Completion Date: | March 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02956057
Please refer to this study by its ClinicalTrials.gov identifier: NCT02956057
Contacts
| Contact: Vladimir Kojecky, MD | +420577552512 | kojecky@bnzlin.cz |
Locations
| Czech Republic | |
| Faculty Hospital Kralovske Vinohrady | Not yet recruiting |
| Prague, Czech Republic, 10024 | |
| Contact: Jan Matous, MD +420267163680 jan.matous1@fnkv.cz | |
Sponsors and Collaborators
Tomas Bata Hospital, Czech Republic
Brno University Hospital
Faculty Hospital Kralovske Vinohrady
Investigators
| Principal Investigator: | Vladimir Kojecky, MD | Nemocnice T.Bati |
More Information
| Responsible Party: | Vladimir Kojecky, MD, Ph.D., MUDr., Tomas Bata Hospital, Czech Republic |
| ClinicalTrials.gov Identifier: | NCT02956057 History of Changes |
| Other Study ID Numbers: |
BN102016 |
| Study First Received: | November 1, 2016 |
| Last Updated: | November 3, 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Additional relevant MeSH terms:
|
Citric Acid Ascorbic Acid Magnesium citrate Picosulfate sodium Anticoagulants Calcium Chelating Agents Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action |
Antioxidants Protective Agents Physiological Effects of Drugs Vitamins Micronutrients Growth Substances Cathartics Gastrointestinal Agents |
ClinicalTrials.gov processed this record on July 17, 2017