NCT01520324

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
6.6 years until next milestone

Results Posted

Study results publicly available

February 8, 2019

Completed
Last Updated

February 8, 2019

Status Verified

September 1, 2018

Enrollment Period

6 months

First QC Date

January 25, 2012

Results QC Date

November 30, 2017

Last Update Submit

September 11, 2018

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (5)

  • Detected Intraepithelial Neoplasia

    Rate of intraepithelial neoplasiae detection in the whole colon.

    During colonscopy (usually <15 min) and subsequent histological analysis

  • Intraepithelial Neoplasia (IN) Detection Rate (True Positive Findings)

    The rate of intraepithelial neoplasiae detection in the whole colon is summarised along with the number and percentage of subjects affected. The number and percentage of false and true negative and of false and true positive findings of intraepithelial neoplasiae are also listed.

    During colonscopy (usually <15 min) and subsequent histological analysis

  • Intraepithelial Neoplasia (IN) Detection Rate (False Positive Findings)

    The rate of intraepithelial neoplasiae detection in the whole colon is summarised along with the number and percentage of subjects affected. The number and percentage of false and true negative and of false and true positive findings of intraepithelial neoplasiae are also listed.

    During colonscopy (usually <15 min) and subsequent histological analysis

  • Intraepithelial Neoplasia (IN) Detection Rate (True Negative Findings)

    The rate of intraepithelial neoplasiae detection in the whole colon is summarised along with the number and percentage of subjects affected. The number and percentage of false and true negative and of false and true positive findings of intraepithelial neoplasiae are also listed.

    During colonscopy (usually <15 min) and subsequent histological analysis

  • Intraepithelial Neoplasia (IN) Detection Rate (False Negative Findings)

    The rate of intraepithelial neoplasiae detection in the whole colon is summarised along with the number and percentage of subjects affected. The number and percentage of false and true negative and of false and true positive findings of intraepithelial neoplasiae are also listed.

    During colonscopy (usually <15 min) and subsequent histological analysis

Secondary Outcomes (3)

  • The Extent and Severity of the Inflamed Mucosa

    During colonscopy (usually <15 min) and subsequent histological analysis

  • The Mucosal Staining Efficacy of Methylene Blue MMX® Tablets After a Total Oral Dose of 200 mg Administered During and at the End of the Intake of the Bowel Cleansing Preparation.

    During colonscopy (usually <15 min) and subsequent histological analysis

  • Bowel Cleansing Quality Evaluated by Boston Bowel Preparation Scale After Intake of Bowel Cleansing Formulation and of a Total Dose of 200 mg of Methylene Blue MMX Tablets Administered During and at the End of the Intake of the Bowel Cleansing Formulation

    During colonscopy (usually <15 min)

Study Arms (1)

Patients with UC undergoing colonoscopy

EXPERIMENTAL
Device: oral delivery mucosal stain

Interventions

oral delivery mucosal stainDEVICE

200mg methylene blue MMX tablet taken prior to colonoscopy

Patients with UC undergoing colonoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • endoscopically verified UC signed written informed consent

You may not qualify if:

  • Known or suspected GI obstruction or perforation Liver or renal impairment, malignancy, pregnancy or lactation, suppressed PT.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Research & Care of Intestinal Diseases

Rozzano, 20089, Italy

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Results Point of Contact

Title
Dr. Richard Jones
Organization
Cosmo Pharmaceuticals NV
RJones@cosmopharma.com
+353 18170370

Study Officials

  • Silvio Danese, MD

    Humanitas Hospital, Italy

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2012

First Posted

January 27, 2012

Study Start

January 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

February 8, 2019

Results First Posted

February 8, 2019

Record last verified: 2018-09

Locations

IT(1)