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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01520324
First Posted: January 27, 2012
Last Update Posted: January 29, 2014
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.
Information provided by (Responsible Party):
Cosmo Technologies Ltd
  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 ]

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

Information from the National Library of Medicine

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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
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
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 ClinicalTrials.gov identifier (NCT number): 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 Hospital, Italy
  More Information

Responsible Party: Cosmo Technologies Ltd
ClinicalTrials.gov Identifier: NCT01520324     History of Changes
Other Study ID Numbers: CB-17-01/04
First Submitted: January 25, 2012
First Posted: January 27, 2012
Last Update Posted: January 29, 2014
Last Verified: January 2014

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