NCT01093274

Brief Summary

Patients intended for ambulatory colonoscopy will be randomized into 2 groups

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 25, 2010

Completed
Last Updated

March 25, 2010

Status Verified

February 1, 2010

First QC Date

February 22, 2010

Last Update Submit

March 24, 2010

Conditions

Bowel Preparation

Keywords

colonoscopyCatharticsSodium picosulfatePolyethylene Glycol

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients requiring repeat colonoscopy because of poor preparation

    Quality of preparation: good, moderate, poor

    quality of preparation will be assessed during colonoscopy

Secondary Outcomes (1)

  • Patient's satisfaction as measured by questionnaire and willingness to repeat same preparation on future examination

    Questionnaire will be filled before colonoscopy

Study Arms (2)

Polyethylene glycol

ACTIVE COMPARATOR

Preparation with Polyethylene Glycol and bisacodyl

Drug: Polyethylene Glycol

Picolax

EXPERIMENTAL

Preparation with Sodium Picosulphate and Bisacodyl.

Drug: Sodium Picosulphate

Interventions

Sodium PicosulphateDRUG

2 Sachets

Picolax
Polyethylene GlycolDRUG

3 Liters solution

Also known as: Meroken new, Go-Lytely
Polyethylene glycol

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Renal insufficiency (serum creatinine ≥2.0 mg/dl)
  • Symptomatic congestive heart failure
  • Recent myocardial infarction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center - Beilinson Hospital

Petah Tikva, 4910, Israel

Location

MeSH Terms

Interventions

picosulfate sodiumPolyethylene Glycols

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Eyal Gal, MD

    Rabin Medical Center - Beilinson hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 22, 2010

First Posted

March 25, 2010

Last Updated

March 25, 2010

Record last verified: 2010-02

Locations

IL(1)