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

This study has been completed.
Information provided by (Responsible Party):
Cosmo Technologies Ltd Identifier:
First received: January 25, 2012
Last updated: January 27, 2014
Last verified: January 2014
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 Intervention
Ulcerative Colitis
Device: oral delivery mucosal stain

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by Cosmo Technologies Ltd:

Primary Outcome Measures:
  • Intraepithelial neoplasia detection rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
mucosal biopsy

Enrollment: 50
Study Start Date: January 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with UC undergoing colonoscopy Device: oral delivery mucosal stain
200mg methylene blue MMX tablet taken prior to colonoscopy


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

No publications provided

Responsible Party: Cosmo Technologies Ltd Identifier: NCT01520324     History of Changes
Other Study ID Numbers: CB-17-01/04
Study First Received: January 25, 2012
Last Updated: January 27, 2014
Health Authority: Italy: AIFA (Agenzia Italiana del Farmaco)

Additional relevant MeSH terms:
Colitis, Ulcerative
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions processed this record on November 25, 2015