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NCT01093274 Clinical Trial

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

Bowel Preparation Clinical Trial

Official title:
Efficacy and Safety of Polyethylene Glycol Compared With Sodium Picosulphate for Bowel Preparation Before Colonoscopy, a Prospective Randomized, Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01093274
Other study ID # Gal001
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 22, 2010
Last updated March 24, 2010

Study information
Verified date February 2010
Source Rabin Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

Patients intended for ambulatory colonoscopy will be randomized into 2 groups

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• Sodium Picosulphate
2 Sachets
• Polyethylene Glycol
3 Liters solution

Locations
Country Name City State
Israel Rabin Medical Center - Beilinson Hospital Petach Tikva

Sponsors (1)
Lead Sponsor Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of patients requiring repeat colonoscopy because of poor preparation Quality of preparation: good, moderate, poor quality of preparation will be assessed during colonoscopy No
Secondary Patient's satisfaction as measured by questionnaire and willingness to repeat same preparation on future examination Patient satisfaction on questionnaire referring to taste, compliance with protocol, side effects, willingness to repeat preparation. Questionnaire will be filled before colonoscopy No
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