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NCT01520337 Clinical Trial

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

Polyp and Adenoma Detection During Colonoscopy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01520337
Other study ID # CB-17-01/05
Secondary ID 2011-005694-23
Status Completed
Phase N/A
First received January 25, 2012
Last updated February 10, 2014
Start date January 2012
Est. completion date October 2013

Study information
Verified date February 2014
Source Cosmo Technologies Ltd
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics CommitteeItaly: The Italian Medicines Agency
Study type Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 170
Est. completion date October 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

  • Polyp and Adenoma Detection During Colonoscopy
  • Polyps

Intervention

Device:
• oral tablet dye for detection of polyps during colonoscopy
oral tablet dye for improved detection of

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Cosmo Technologies Ltd

Outcome
Type Measure Description Time frame Safety issue
Primary Polyp and adenoma detection rate 1 day No