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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cosmo Technologies Ltd
ClinicalTrials.gov Identifier:
NCT01520324
First received: January 25, 2012
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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

  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT01520324

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

No publications provided

Responsible Party: Cosmo Technologies Ltd
ClinicalTrials.gov 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:
Neoplasms
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014