Polyp Detection Rate After Single Oral Dose of Methylene Blue MMX Modified Release Tablets Administered to Subjects Undergoing Outpatients Colonoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cosmo Technologies Ltd
ClinicalTrials.gov Identifier:
NCT01520337
First received: January 25, 2012
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

Polyp detection rate in colonoscopy following oral administration of MMX methylene blue tablets


Condition Intervention
Polyp and Adenoma Detection During Colonoscopy
Device: oral tablet dye for detection of polyps during colonoscopy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Polyp Detection Rate After Single Oral Dose of Methylene Blue MMX Modified Release Tablets Administered to Subjects Undergoing Outpatients Colonoscopy

Resource links provided by NLM:


Further study details as provided by Cosmo Technologies Ltd:

Primary Outcome Measures:
  • Polyp and adenoma detection rate [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

mucosal biopsy


Enrollment: 170
Study Start Date: January 2012
Study Completion Date: October 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
patients undergoing outpatient colonoscopy Device: oral tablet dye for detection of polyps during colonoscopy
oral tablet dye for improved detection of

Detailed Description:

Polyp detection rate in colonoscopy following oral administration of methylene blue MMX modified release tablets in subjects undergoing colonoscopy as outpatients.

  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 scheduled for screening or surveillance colonoscopy.

Criteria

Inclusion Criteria:

  • Patients scheduled for screening or surveillance colonoscopy. Written informed consent.Practising reliable contraception or sterile.Ability to understand and comply with the protocol.

Exclusion Criteria:

  • Pregnancy or lactation known or suspected hypersensitivity GI obstruction or perforation serious cardiovascular, renal or hepatic disease. reduced prothrombin time,elevated serum creatinine.
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Cosmo Technologies Ltd
ClinicalTrials.gov Identifier: NCT01520337     History of Changes
Other Study ID Numbers: CB-17-01/05, 2011-005694-23
Study First Received: January 25, 2012
Last Updated: February 10, 2014
Health Authority: Italy: Ethics Committee
Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Polyps
Pathological Conditions, Anatomical
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014