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

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ClinicalTrials.gov Identifier: NCT01520337
Recruitment Status : Completed
First Posted : January 27, 2012
Last Update Posted : February 11, 2014
Sponsor:
Information provided by (Responsible Party):
Cosmo Technologies Ltd

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

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

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

Study Type : Observational
Actual Enrollment : 170 participants
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
Study Start Date : January 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Group/Cohort Intervention/treatment
patients undergoing outpatient colonoscopy Device: oral tablet dye for detection of polyps during colonoscopy
oral tablet dye for improved detection of



Primary Outcome Measures :
  1. Polyp and adenoma detection rate [ Time Frame: 1 day ]

Biospecimen Retention:   Samples Without DNA
mucosal biopsy


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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.

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 Posted: January 27, 2012    Key Record Dates
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