Polyp Detection Rate After Single Oral Dose of Methylene... | NCT01520337

ID	Type	Description	Link
2011-005694-23	EudraCT Number

Status Module

Record Verification Date

Feb 2014

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 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Jan 25, 2012

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

Feb 10, 2014

Last Update Posted Date

Feb 11, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Polyp detection rate in colonoscopy following oral administration of MMX methylene blue tablets

Detailed Description

Polyp detection rate in colonoscopy following oral administration of methylene blue MMX modified release tablets in subjects undergoing colonoscopy as outpatients.

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

Retention

Enrollment

170Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients undergoing outpatient colonoscopy			Device: oral tablet dye for detection of polyps during colonoscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oral tablet dye for detection of polyps during colonoscopy	Device	oral tablet dye for improved detection of	patients undergoing outpatient colonoscopy

Measure	Description	Time Frame
Polyp and adenoma detection rate		1 day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients scheduled for screening or surveillance colonoscopy. Written informed consent.Practising reliable contraception or sterile.Ability to understand and comply with the protocol.

Exclusion Criteria:

Pregnancy or lactation known or suspected hypersensitivity GI obstruction or perforation serious cardiovascular, renal or hepatic disease. reduced prothrombin time,elevated serum creatinine.

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

patients scheduled for screening or surveillance colonoscopy.

Sampling Method

Non-Probability Sample

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Cosmo Technologies Ltd

Unposted Events

Type	Date	Date Unknown
Release	Jan 29, 2019
Reset	May 1, 2019
Release	May 10, 2021

Violation Annotation

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

Estimated Results First Submitted Date

Jan 29, 2019

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jan 29, 2019			May 1, 2019
May 10, 2021			Jun 4, 2021
Dec 9, 2022			Oct 13, 2023

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms