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Sodium Picosulfate Plus Magnesium Citrate Versus Macrogol 4000 in the Bowel Cleansing Procedure: a Comparison of Efficiency and Compatibility

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01607099
First received: May 24, 2012
Last updated: November 13, 2014
Last verified: November 2014
  Purpose

For effective cleansing of the bowel prior to colonoscopy polyethylene glycol (e.g. macrogol) has widely been used in Germany. Usually patients have to drink between 4 an 6 liter of macrogol in a split dose (3 liter on the day before and 1 to 3 liter on the of the examination). One handicap of using polyethylene glycol is the occurence of nausea and vomiting which is due to the high amount of the laxativ and its bad taste. Therefore in a pilot study the investigators have detected a high fraction of patients who consider the cleansing procedure wich macrogol as "very distressing". Thus patient acceptance of the colonoscopy procedure altogether is low.

Since a few month sodium picosulfate/magnesium citrate is available for bowel cleansing in Germany. This preparation tastes better and needs less fluid intake. Usually 150 ml of sodium picosulfate/magnesium citrate are given twice within a 12 hour interval. Patients are instructed to drink plenty of water in addition to the laxative. In the mentioned pilot study the investigators found the cleansing procedure with picosulfate/magnesium citrate to be much more compatible compared to the macrogol regime. The effectiveness expressed by the cleanness of the bowel was equal in both groups.

The investigators believe that a new protocol which contains sodium picosulfate/magnesium citrate instead of macrogol will benefit the patients by fewer abdominal side effects while cleanness of the bowel at the same time will be warranted. This presumption is the reason for the present study.


Condition Intervention
Laxative Compatibility
Procedure: Compatibility

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Sodium Picosulfate Plus Magnesium Citrate Versus Macrogol 4000 in the Bowel Cleansing Procedure: a Comparison of Efficiency and Compatibility

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Valuation "very distressing" [ Time Frame: Just before colonoscopy up to 4 hours afterwards (0 to aprox 4 hours) ] [ Designated as safety issue: No ]
    Patients will fill in a report in which they rate the stress triggered by the bowel cleansing procedure. The level ranges from 1 to 10 points. Valuations from 8 to 10 points will be considered as very distressing.


Secondary Outcome Measures:
  • Colon cleanness [ Time Frame: From the start to the end of colonoscopy, i.e. from 0 h to approximately 2 h ] [ Designated as safety issue: No ]

Enrollment: 220
Study Start Date: September 2012
Study Completion Date: November 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pico Prep
Arm in which sodium- picosulfate/magnesium citrate is used for bowel cleansing
Procedure: Compatibility
Patients asses the compatibility of the bowel cleansing procedure
No Intervention: Standard
The standard drug macrogol is used for bowel cleansing

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age >= 18
  • Scheduled for colonoscopy

Exclusion Criteria:

  • No informed consent
  • ASA IV or V
  • Pregnancy
  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: NCT01607099

Locations
Germany
Technische Universität München
Munich, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Investigators
Principal Investigator: Peter Klare, MD Technische Universität München
Study Director: Wolfgang Huber, MD Technische Universität München
  More Information

No publications provided

Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01607099     History of Changes
Other Study ID Numbers: PicoPrep
Study First Received: May 24, 2012
Last Updated: November 13, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität München:
colonoscopy
bowel cleansing
bowel cleanness
efficiency
compatibility

Additional relevant MeSH terms:
Magnesium citrate
Picosulfate sodium
Cathartics
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014