Comparing Oral Preparation With Macrogol (Moviprep) and N... | NCT01705262

Studies
Comparing Oral Preparation With Macrogol (Moviprep) and Natriumdihydrogenphosphatdihydrat (Phosphoral)

NCT01705262

Sponsor

Odense University Hospital

Status

Terminated

Last Update Posted

Apr 5, 2017Actual

Enrollment

80Actual

Phase

Not provided

Conditions

Colonoscopy

Interventions

Not provided

Countries

Denmark

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

Apr 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Phophoral was no longer used as a preparation before coloscopies at OUH

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Oct 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Jan 27, 2012

First Submission Date that Met QC Criteria

Oct 11, 2012

First Posted Date

Oct 12, 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

Apr 3, 2017

Last Update Posted Date

Apr 5, 2017Actual

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 purpose of this study is to determine whether Moviprep or Phosphoral is the best method of bowel preparation before colonoscopy - seen by the patients and by the endoscopist.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
u-65 M		Male patients under 65
u-65 K		Female patients under 65 years old
o-65 -K		Female patients over 65 years
O-65 M		Male patients over 65 years

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

primary diagnostic colonoscopy,
colonoscopy as a follow-up,
intended therapeutic colonoscopy.

Exclusion Criteria:

patients younger than 18 years
pregnancy
known bowl obstructions
known inflammatory colon disease
known kidney disease
phenylketonuri
glucose-6-phospat deficiency

Accepts Healthy Volunteers

Yes

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

Patients referred to colonoscopy by the house doctors

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Surgery department		Odense	Odense	5250	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D010349	Patient Compliance

Ancestor Terms

ID	Term
D010342	Patient Acceptance of Health Care
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided