Trial · Interventional

CompletedPhase 3Results postedRegistry data

The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy

NCTNCT01694966Other idCB-17-01/06Other id2012-003983-32

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 1,249 participants (actual)
Sponsor: Cosmo Technologies Ltd · Industry
Design: Randomized · Double masking
Countries: 8 countries
United States, Belgium, Canada, Germany, Italy, Lithuania, Netherlands, United Kingdom
Start: Sept 2013
Primary completion: Oct 2016
Completion: Oct 2016
First posted: 27 Sept 2012 (estimated)
Last update posted: 6 Nov 2017
Conditions: Colorectal Cancer

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20132014201520162017

Ph 3
The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy
NCT01694966
Sept 2013 to Oct 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Evaluation of the histologically proven adenoma and carcinoma detection rate in patients undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with 200 mg of Methylene Blue MMX® tablets.

Interventions

Methylene Blue MMX®Drug
PlaceboDrug

Arms3

Active comparator
Methylene Blue MMX® 200mg
Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule
Active comparator
Methylene Blue MMX® 100mg
Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule
Placebo comparator
Placebo
Oral dose, 8 Placebo tablets over a 4hr schedule

Primary outcomes1

Outcomes the sponsor listed as primary.

To Assess the Detection Efficacy of Chromoendoscopy Performed With 200mg Methylene Blue MMX® 25 mg Tablets Versus Placebo Tablets (White Light Endoscopy) in Terms of the Proportion of Subjects With at Least One Histologically Proven Adenoma or Carcinoma.
Time frame · +7 days
Registry description
Adenoma Detection Rate

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· +7 days

To Assess the Detection Efficacy of Chromoendoscopy Performed With 200mg Methylene Blue MMX® 25 mg Tablets Versus Placebo Tablets (White Light Endoscopy) in Terms of the Proportion of Subjects With at Least One Histologically Proven Adenoma or Carcinoma.

Group	Value (percentage of participants)
Methylene Blue MMX® 200mg	56.3
Methylene Blue MMX® 100mg	51.5
Placebo	47.8

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Methylene Blue MMX® 200mgOral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule Methylene Blue MMX®	–	1 / 485	234 / 488
Methylene Blue MMX® 100mgOral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule Methylene Blue MMX® Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet.	–	1 / 241	102 / 241
PlaceboOral dose, 8 Placebo tablets over a 4hr schedule Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet.	–	0 / 479	7 / 479

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedRepici A, Wallace MB, East JE, Sharma P, Ramirez FC, Bruining DH, Young M, Gatof D, Irene Mimi Canto M, Marcon N, Cannizzaro R, Kiesslich R, Rutter M, Dekker E, Siersema PD, Spaander M, Kupcinskas L, Jonaitis L, Bisschops R, Radaelli F, Bhandari P, Wilson A, Early D, Gupta N, Vieth M, Lauwers GY, Rossini M, Hassan C. Efficacy of Per-oral Methylene Blue Formulation for Screening Colonoscopy. Gastroenterology. 2019 Jun;156(8):2198-2207.e1. doi: 10.1053/j.gastro.2019.02.001. Epub 2019 Feb 10. PMID 30742834

Eligibility

Who could join, as posted.

Sex: All
Age: from 50 Years up to 75 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Males or females, aged between 50 and 75. * Outpatients scheduled for screening or surveillance colonoscopy for polyps or colorectal cancer ) * Able to comprehend the full nature and purpose of the study, including possible risks and side effects. * Able to co-operate with the investigator and to comply with the requirements of the entire study. * Signed written informed consent prior to inclusion in the study. Exclusion Criteria: * Patients at high risk of colorectal cancer e.g. ulcerative colitis * Previous medical history of, or suspected hypersensitivity to, the Methylene Blue and/or formulations' ingredients. * Previous medical history of, or suspected hypersensitivity to, the PEG based bowel cleansing preparation and/or bowel cleansing formulations' ingredients. * Previous medical history of gastrointestinal obstruction or perforation, toxic megacolon, major colonic resection, severe diverticulitis, heart failure (Class III or IV), serious cardiovascular disease, ulcerative colitis or Crohn's disease.

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