Trial Comparing Moviprep and Phosphoral as Bowel Prep Bef... | NCT01519609

Studies
Trial Comparing Moviprep and Phosphoral as Bowel Prep Before Colonoscopy

NCT01519609

Sponsor

Randers Regional Hospital

Status

Completed

Last Update Posted

Nov 21, 2012Estimated

Enrollment

400Actual

Phase

Not Applicable

Conditions

Colorectal Cancer

Interventions

bowel prep before endoscopy

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

Nov 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

Sep 2011

Primary Completion Date

Nov 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Sep 16, 2011

First Submission Date that Met QC Criteria

Jan 26, 2012

First Posted Date

Jan 27, 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

Nov 20, 2012

Last Update Posted Date

Nov 21, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Thorbjorn Sommer, M.D, Ph.D Associate Professor, Randers Regional HospitalPrincipal Investigator

Lead Sponsor

Randers Regional HospitalOTHER

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

Using Moviprep patients use shorter time to do a bowel prep before colonoscopy. No major single center has docuemted the advantage of using moviprep as bowel prep before colonoscopy.This randomised study was conducted to compare moviprep with the present standard: Phosphoral to investigate the degree of bowel cleasing before colonoscopy in patients suspected of colorectal cancer, and to investigate number of days where patients need to stay home.

Detailed Description

Not provided

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

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Moviprep	Active Comparator	Moviprep bowel preb	Drug: bowel prep before endoscopy
Phosphoral	Active Comparator	Bowel prep	Drug: bowel prep before endoscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bowel prep before endoscopy	Drug	bowel prep before colonoscopy	Moviprep Phosphoral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Degree of bowel cleansing	Will be estimated by the patients and the colonoscopist	1 Day of colonoscopy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients suspected of colorectal cancer scheduled for colonoscopy

Exclusion Criteria:

Patients with previous colorectal surgery
Colonis Stenosis
ASA > 2

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
thorbjorn sommer, ph.D	unaffilated	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Randers Regions Hospital		Randers		8970	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided