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

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ClinicalTrials.gov Identifier: NCT01093274
Recruitment Status : Unknown
Verified February 2010 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 25, 2010
Last Update Posted : March 25, 2010
Sponsor:
Information provided by:
Rabin Medical Center

Brief Summary:
Patients intended for ambulatory colonoscopy will be randomized into 2 groups

Condition or disease Intervention/treatment Phase
Bowel Preparation Drug: Sodium Picosulphate Drug: Polyethylene Glycol Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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 the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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.



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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

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

Responsible Party: Eyal Gal MD, Rabin Medical Center- Beilinson hospital
ClinicalTrials.gov Identifier: NCT01093274     History of Changes
Other Study ID Numbers: Gal001
First Posted: March 25, 2010    Key Record Dates
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