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

Completed

• Conditions: Polyp and Adenoma Detection During Colonoscopy
• Interventions: Device: oral tablet dye for detection of polyps during colonoscopy

• Registration Number: NCT01520337
• Lead Sponsor: Cosmo Technologies Ltd

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-25
• Study First Submitted QC: 2012-01-26
• Study First Posted: 2012-01-27
• Primary Completion: 2013-03
• Study Completion: 2013-10
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-10
• Last Update Posted: 2014-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients undergoing outpatient colonoscopy	oral tablet dye for detection of polyps during colonoscopy	-

Primary Outcome Measures

Name	Time	Method
Polyp and adenoma detection rate	1 day