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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-10-31

Brief Summary

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

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Detailed Description

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

Conditions

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Polyp and Adenoma Detection During Colonoscopy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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patients undergoing outpatient colonoscopy

oral tablet dye for detection of polyps during colonoscopy

Intervention Type DEVICE

oral tablet dye for improved detection of

Interventions

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oral tablet dye for detection of polyps during colonoscopy

oral tablet dye for improved detection of

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No