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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:
ClinicalTrials.gov Identifier:
NCT01520337
First Posted: January 27, 2012
Last Update Posted: February 11, 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
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 ]

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

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 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
No Contacts or Locations Provided
  More Information

Responsible Party: Cosmo Technologies Ltd
ClinicalTrials.gov Identifier: NCT01520337     History of Changes
Other Study ID Numbers: CB-17-01/05
2011-005694-23 ( EudraCT Number )
First Submitted: January 25, 2012
First Posted: January 27, 2012
Last Update Posted: February 11, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Polyps
Adenoma
Pathological Conditions, Anatomical
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action