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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01520324
Recruitment Status : Completed
First Posted : January 27, 2012
Last Update Posted : January 29, 2014
Information provided by (Responsible Party):
Cosmo Technologies Ltd

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.

Condition or disease Intervention/treatment
Ulcerative Colitis Device: oral delivery mucosal stain

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Intraepithelial Neoplasia Detection Rate After Single Oral Dose of Methylene Blue MMX Modified Release Tablets Administered to Patients With Long Standing Ulcerative Colitis Undergoing Colonoscopy.
Study Start Date : January 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Patients with UC undergoing colonoscopy Device: oral delivery mucosal stain
200mg methylene blue MMX tablet taken prior to colonoscopy

Primary Outcome Measures :
  1. Intraepithelial neoplasia detection rate [ Time Frame: 1 year ]

Biospecimen Retention:   Samples Without DNA
mucosal biopsy

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with long standing ulcerative colitis undergoing colonoscopy

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01520324

Centre for Research & Care of Intestinal Diseases
Rozzano, Italy, 20089
Sponsors and Collaborators
Cosmo Technologies Ltd
Principal Investigator: Silvio Danese, MD Humanitas Hospital, Italy

Responsible Party: Cosmo Technologies Ltd Identifier: NCT01520324     History of Changes
Other Study ID Numbers: CB-17-01/04
First Posted: January 27, 2012    Key Record Dates
Last Update Posted: January 29, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action