Polyethylene Glycol Versus Sodium Phosphate for Colon Pre... | NCT00558376

Studies
Polyethylene Glycol Versus Sodium Phosphate for Colon Preparation After Failure of First Preparation for Colonoscopy

NCT00558376

Sponsor

Sheba Medical Center

Status

Terminated

Last Update Posted

Jun 14, 2018Actual

Enrollment

23Actual

Phase

Not Applicable

Conditions

Colonoscopy

Interventions

polyethylene glycol
Sodium phosphate

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study terminated due to FDA alert regarding Fleet phosphosoda

Expanded Access Info

Start Date

Jan 2008Actual

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Nov 13, 2007

First Submission Date that Met QC Criteria

Nov 13, 2007

First Posted Date

Nov 14, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2018

Last Update Posted Date

Jun 14, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Shomron BenHorin, Professor, Sheba Medical CenterPrincipal Investigator

Lead Sponsor

Sheba Medical CenterOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the study is to compare the efficacy of Polyethylene glycol versus sodium phosphate as purgative for colon preparation to colonoscopy, after the failure of preparation with sodium phosphate for first colonoscopy. The hypothesis tested is whether there is advantage for substituting the purgative used, as compared to repeating the colonoscopy with the same purgative.Briefly, patients whose preparation was inadequate, will be allocated randomly to a group that will receive 3L Polyethylene glycol versus a group that will receive sodium phosphate(45ccX2). Both groups will be instructed to extend low-fiber diet to 5 days. Cleanliness of the colon at colonoscopy will be assessed blindly by an experienced endoscopist.

Detailed Description

The aim of the study is to compare the efficacy of Polyethylene glycol versus sodium phosphate as purgative for colon preparation to colonoscopy, after the failure of preparation with sodium phosphate for first colonoscopy. The hypothesis tested is whether there is advantage for substituting the purgative used, as compared to repeating the colonoscopy with the same purgative.Briefly, the study will be composed of patients whose preparation was judged to be inadequate in a first colonoscopy by an endoscopist independent of the current study. They will be allocated randomly to a group that will receive 3L Polyethylene glycol versus a group that will receive sodium phosphate(45ccX2). Both groups will be instructed to extend low-fiber diet to 5 days. Cleanliness of the colon at colonoscopy will be assessed blindly by an experienced endoscopist.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Ingestion of 3L polyethylene Glycol	Drug: polyethylene glycol
2	Active Comparator	Ingestion of 2 doses of sodium phosphate 45 cc	Drug: Sodium phosphate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
polyethylene glycol	Drug	Single time 3 liters PEG, 250 cc every 15 minutes the day before colonoscopy	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Colon cleanliness at the second colonoscopy		within 24 hours of purgative ingestion, and within 30 minutes of colonoscopy

Secondary Outcomes

Measure	Description	Time Frame
Tolerability of purgative regimen		within 24 hours of purgative ingestion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Failed colonoscopy due to inadequate preparation
Able to understand and sign an informed consent
Preparation for frst colonoscopy consisted of sodium phosphate

Exclusion Criteria:

Significant heart disease or CHF
Chronic Renal Failure
Allergy to any of the purgative ingredients
Pregnancy
Alcohol and/or drug abuse
Vomiting or aspiration
Suspected bowel obstruction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shomron Ben-Horin, MD	Sheba Medical Center	Principal Investigator
Benjamin Avidan, MD	Sheba Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba_Medical_Center		Tel Litwinsky		52961	Israel

Intervention Browse Module

MeSH Terms

ID	Term
D011092	Polyethylene Glycols
C000595212	polyethylene glycol 3350
C018279	sodium phosphate

Ancestor Terms

ID	Term
D005026	Ethylene Glycols
D006018	Glycols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided