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Efficacy and Safety of Polyethylene Glycol Compared With Sodium Picosulphate for Bowel Preparation Before Colonoscopy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2010 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01093274
First Posted: March 25, 2010
Last Update Posted: March 25, 2010
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.
Information provided by:
Rabin Medical Center
  Purpose
Patients intended for ambulatory colonoscopy will be randomized into 2 groups

Condition Intervention
Bowel Preparation Drug: Sodium Picosulphate Drug: Polyethylene Glycol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Diagnostic
Official Title: Efficacy and Safety of Polyethylene Glycol Compared With Sodium Picosulphate for Bowel Preparation Before Colonoscopy, a Prospective Randomized, Controlled Study

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Percentage of patients requiring repeat colonoscopy because of poor preparation [ Time Frame: quality of preparation will be assessed during colonoscopy ]
    Quality of preparation: good, moderate, poor


Secondary Outcome Measures:
  • Patient's satisfaction as measured by questionnaire and willingness to repeat same preparation on future examination [ Time Frame: Questionnaire will be filled before colonoscopy ]
    Patient satisfaction on questionnaire referring to taste, compliance with protocol, side effects, willingness to repeat preparation.


Estimated Enrollment: 200
Arms Assigned Interventions
Active Comparator: Polyethylene glycol
Preparation with Polyethylene Glycol and bisacodyl
Drug: Polyethylene Glycol
3 Liters solution
Other Names:
  • Meroken new
  • Go-Lytely
Experimental: Picolax
Preparation with Sodium Picosulphate and Bisacodyl.
Drug: Sodium Picosulphate
2 Sachets

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ambulatory patients scheduled for elective colonoscopy
  • Age 18-80

Exclusion Criteria:

  • Renal insufficiency (serum creatinine ≥2.0 mg/dl)
  • Symptomatic congestive heart failure
  • Recent myocardial infarction
  Contacts and Locations
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): NCT01093274


Locations
Israel
Rabin Medical Center - Beilinson Hospital
Petach Tikva, Israel, 4910
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Eyal Gal, MD Rabin Medical Center - Beilinson hospital
  More Information

Responsible Party: Eyal Gal MD, Rabin Medical Center- Beilinson hospital
ClinicalTrials.gov Identifier: NCT01093274     History of Changes
Other Study ID Numbers: Gal001
First Submitted: February 22, 2010
First Posted: March 25, 2010
Last Update Posted: March 25, 2010
Last Verified: February 2010

Keywords provided by Rabin Medical Center:
colonoscopy
Cathartics
Sodium picosulfate
Polyethylene Glycol

Additional relevant MeSH terms:
Picosulfate sodium
Cathartics
Gastrointestinal Agents