Neoplasia Detection With Methylene Blue MMX Tablets in Patients With UC Undergoing Colonoscopy

NCT ID: NCT01520324

Last Updated: 2019-02-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-07-31

Brief Summary

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Evaluation of the intraepithelial neoplasia detection rate in patients with long standing ulcerative colitis undergoing mucosal staining with oral methylene blue MMX tablets prior to colonoscopy.

Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with UC undergoing colonoscopy

Group Type EXPERIMENTAL

oral delivery mucosal stain

Intervention Type DEVICE

200mg methylene blue MMX tablet taken prior to colonoscopy

Interventions

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oral delivery mucosal stain

200mg methylene blue MMX tablet taken prior to colonoscopy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* endoscopically verified UC signed written informed consent

Exclusion Criteria

* Known or suspected GI obstruction or perforation Liver or renal impairment, malignancy, pregnancy or lactation, suppressed PT.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cosmo Technologies Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Silvio Danese, MD

Role: PRINCIPAL_INVESTIGATOR

Humanitas Hospital, Italy

Locations

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Centre for Research & Care of Intestinal Diseases

Rozzano, , Italy

Site Status

Countries

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Italy

Other Identifiers

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CB-17-01/04

Identifier Type: -

Identifier Source: org_study_id

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