Effect of Oral Administration of Methylene Blue MMX Tablets on Double Stranded DNA

NCT02295774 | Completed Phase 2 Results

• 2 other identifiers: CB-17-01/082013-000634-35
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Single Centre, open label assignment phase II clinical study. To evaluate the effect of oral 200mg Methylene Blue tablets (administered 8x25mg) prior to endoscopy on double stranded DNA breaks in colonic biopsy samples assessed by histone gamma H2AX analysis, compared to control biopsies.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Gamma H2AX Histone Levels in Colonic Biopsy During Standard White Light Colonoscopy and Colonoscopy for Which Methylene Blue MMX Was Taken Prior to Initiating the Colonoscopy

  Assay of gamma H2AX histone phosphorylation in biopsy samples collected during colonoscopy.

  2 weeks

Secondary Outcomes (1)

• To Evaluate the Staining Quality Obtained With Oral Methylene Blue MMX® Tablets.

  During the colonoscopy

Study Arms (2)

Group A

PLACEBO COMPARATOR

Biopsy samples collected during standard white light colonoscopy.

Procedure: standard white light colonoscopy-equivalent to placebo

Group B

ACTIVE COMPARATOR

Subjects who have had samples collected during a Group A colonoscopy, who require a second colonoscopy within 2 weeks. Prior to this second colonoscopy the subjects take Methylene Blue MMX tablets. Biopsies collected are compared to their previous group A colonoscopy for histone gamma H2AX activity.

Drug: Methylene Blue MMX tablets

Interventions

standard white light colonoscopy-equivalent to placebo PROCEDURE

standard white light colonoscopy

Group A

Methylene Blue MMX tablets DRUG

8x25mg methylene blue MMX tablets administered before a colonoscopy

Group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females, aged between 18 and 75.
• Outpatients scheduled for screening or surveillance colonoscopy
• Subjects must be identified as having the clinical requirement for second colonoscopy within 2weeks of the initial colonoscopy.
• Women of childbearing potential must use at least one reliable method of contraception, be surgically sterilised or be abstinent.
• For female subjects, a negative serum pregnancy test is required before Methylene Blue MMX® tablets are dispensed to the subject.
• Post menopausal patients need to have a period of greater than 1year since last menstrual period.
• Subjects must be able to comprehend the full nature and purpose of the study, including possible risks and side effects.
• Subjects must be able to co-operate with the investigator and to comply with the requirements of the entire study.

You may not qualify if:

• No Pregnant or lactating women, or women undergoing fertility treatment.
• No previous medical history of, or suspected hypersensitivity to the Methylene Blue and/or this formulations ingredients.
• No previous medical history of, or suspected hypersensitivity to the PEG based bowel cleansing preparation and/or this formulations ingredients.
• No previous medical history of gastrointestinal obstruction or perforation, toxic megacolon, major colonic resection, severe diverticulitis, heart failure (Class III or IV), serious cardiovascular disease.
• No ALT, AST, GGT, Bilirubin, Creatinine or Urea greater than 2.5 x the upper limit for normal, based on local laboratory testing.
• No clinical alarm symptoms or history of anaemia (previously recorded haemoglobin of less than 10mg/dL) or frank blood in the stool within the last 30 days prior to enrolment.
• No known deficiency of glucose-6-phosphate dehydrogenase.
• No known deficiency of NADPH reductase.
• No treatment within 5 weeks prior to randomisation with Fluoxetine (Prozac).
• No concurrent treatment, or previous treatment within 2 weeks with any of the prohibited psychiatric medications that may interact with Methylene Blue as listed in the Prohibited Medications section; Selective Serotonin Reuptake Inhibitors (SSRI), Serotonin-Norepinepherine Reuptake Inhibitors (SNRI's), listed Tricyclic anti-depressants or Monoamine oxidase A inhibitors.
• No concurrent treatment with anticoagulants, or antiaggregants, inducing an INR \> 1.5.
• No current enrolment in any other clinical trial, or previous enrolment in a clinical trial within the last 30 days.
• No other medical condition that in the investigators opinion would make the administration of the study drug or procedures hazardous to the subject.

Sponsors & Collaborators

• Cosmo Technologies Ltd: lead

Study Sites (1)

IRCCS Instituto Clinico Humanitas

Rozzano, 20089, Italy

Location

Related Publications (1)

• Repici A, Ciscato C, Wallace M, Sharma P, Anderloni A, Carrara S, Di Leo M, Hassan C. Evaluation of genotoxicity related to oral methylene blue chromoendoscopy. Endoscopy. 2018 Oct;50(10):1027-1032. doi: 10.1055/a-0630-1004. Epub 2018 Jun 15.

  PMID: 29906809 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Alessandro Repici MD
• Organization: Humanitas Research Hospital & Humanitas University

alessandro.repici@hunimed.eu

00390282247493

Study Officials

• Alessandro Repici, MD

  IRCCS Instituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2014
• First Posted: November 20, 2014
• Study Start: February 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 5, 2018
• Results First Posted: January 13, 2016

Record last verified: 2018-04

Locations

IT (1)