Low Volume PEG With Low Residue Test Meals Versus High Vo... | NCT01568814

Studies
Low Volume PEG With Low Residue Test Meals Versus High Volume Split-dose PEG Bowel Preparation

NCT01568814

Sponsor

Inje University

Status

Completed

Last Update Posted

Apr 3, 2012Estimated

Enrollment

188Actual

Phase

Phase 3

Conditions

Bowel Preparation
Colonoscopy

Interventions

Low volume PEG
high volume PEG

Countries

South Korea

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

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Mar 2012Actual

Completion Date

Mar 2012Actual

First Submitted Date

Mar 29, 2012

First Submission Date that Met QC Criteria

Mar 29, 2012

First Posted Date

Apr 2, 2012Estimated

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

Mar 30, 2012

Last Update Posted Date

Apr 3, 2012Estimated

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

Morning only low volume PEG with low reside meals may enhance patient tolerability and have similar bowel cleansing efficacy compared to standard method using high volume split-dose PEG with standard diet.

Detailed Description

We aimed to evaluate the efficacy and tolerability of bowel preparation protocols with low volume PEG and low residue meals PEG compared to conventional high volume (4L) split-dose and standard diet.

Entry criteria: Entry criteria: Adult outpatients and inpatients (18-85 years of age) who undergo colonoscopy for screening, cancer surveillance or with gastrointestinal symptoms, other symptoms

Primary Outcome: Quality of bowel preparation (Ottawa scale) Secondary Outcome: Tolerability (preparation completion, side effect), acceptance, willingness

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

188Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High volume PEG	Placebo Comparator	Patients who are scheduled colonoscopy ingest high volume PEG(4L) for bowel preparation.	Drug: high volume PEG
Low volume PEG with low residual meals	Active Comparator	Patients who are scheduled colonoscopy ingest low volume PEG(2L) and have a prepackaged low residual meals for bowel preparation.	Drug: Low volume PEG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Low volume PEG	Drug	low volume polyethylene glycol 2 liter one time	Low volume PEG with low residual meals

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of bowel preparation	Quality of bowel preparation is assessed using Ottawa bowel preparation scale.	2 months

Secondary Outcomes

Measure	Description	Time Frame
Tolerability	Tolerability of bowel preparation regimen is assessed by patient questionnaire.	2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult outpatients and inpatients (18-85 years of age) who undergo colonoscopy for screening, cancer surveillance or with gastrointestinal symptoms, other symptoms

Exclusion Criteria:

Age under 18 years
Pregnancy
Breast feeding
Prior history of surgical large bowel resection
Severe medical condition such as severe cardiac
Hepatic, renal failure (creatinine ≥ 3.0mg/dL (normal 0.8-1.4))
Drug addiction or major psychiatric illness
Suspected bowel obstruction or ileus
Allergy to PEG
Refusal of consent to participate in the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Haeundae Paik Hospital, Inje University School of Medicine		Busan		612-030	South Korea