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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Rabin Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01093274
First received: February 22, 2010
Last updated: March 24, 2010
Last verified: February 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Eyal Gal MD, Rabin Medical Center- Beilinson hospital
ClinicalTrials.gov Identifier: NCT01093274     History of Changes
Other Study ID Numbers: Gal001
Study First Received: February 22, 2010
Last Updated: March 24, 2010
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on July 24, 2014