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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Colon Staining Efficacy of Single Oral Doses of Methylene Blue MMX

Short name CRO-11-108

NCTNCT03287219 (opens ClinicalTrials.gov in a new tab)Other idCB-17-01/03
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
114 participants (actual)
Sponsor
Cosmo Technologies Ltd · Industry
Design
Not randomized · Open label (no masking)
Countries
Not stated
Start
2 May 2011
Primary completion
16 Jan 2012
Completion
16 Jan 2012
First posted
19 Sept 2017
Last update posted
28 Jan 2021
Conditions
Colon Staining in Preparation for Colonoscopy

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201120122013
  1. Ph 2

    CRO-11-108

    NCT03287219

    2 May 2011 to 16 Jan 2012

Registry summary

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

To describe and evaluate the mucosal staining efficacy of Methylene Blue MMX® tablets after total oral doses of 150 or 200 mg in patients undergoing a full colonoscopy for various reasons.

Interventions

  • Methylene Blue MMX 25 mg modified release tabletsDrug

Arms2

  • Active comparator

    150 mg Methylene Blue-MMX tablets

    take 6 x 25mg Methylene Blue-MMX tablets equivalent to 150 mg

  • Active comparator

    200 mg Methylene Blue-MMX tablets

    take 8 x 25mg Methylene Blue-MMX tablets equivalent to 200 mg

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Evaluation of Mucosal Staining Efficacy

    Time frame · One day- mucosal staining efficacy is assessed during the colonoscopy procedure

    Registry description

    Mucosal staining efficacy of Methylene Blue MMX tablets after total oral doses of 150 or 200 mg. Methylene blue staining efficacy was assessed by scoring the observed percentage of staining as reported below for each colon region (AC, TC, DC, RES) 0 - no staining 1. \- traces (poor traces in colon mucosa) 2. \- detectable (at least the 25% of colon mucosa is stained) 3. \- acceptable (at least the 50% of colon mucosa is stained) 4. \- good (at least the 75% of colon mucosa is stained) 5. \- over stained ( the 100% of the colon mucosa is over stained) After scoring (SC) separately each colonic segment, the total staining score (TSC) was also calculated and the number of regions with an SC\>2 (NSA) was determined. For each patient, the best effective TSC was set at 16, when SC=4 was detected in all 4 regions. SC=5 detected in any region and TSC\>16, both denoting an overstaining of the mucosa, were defined as suboptimal results in colon staining.

Secondary outcomes(6)

  1. Safety and Tolerability of Methylene Blue MMX as Determined by Vital Signs (Blood Pressure)

    Time frame · until study completion (until 2 days after dose)

    Registry description

    safety and tolerability of Methylene Blue MMX reviewed by incidence of treatment emergent by measurement of vital signs (blood pressure)

  2. Safety and Tolerability of Methylene Blue MMX as Determined by AEs

    Time frame · Until study completion (until 2 days after dose)

    Registry description

    Safety and tolerability of Methylene Blue MMX® tablets after administration of total oral doses of 150 or 200 mg.AEs were assessed throughout the study.

  3. Safety and Tolerability of Methylene Blue MMX as Determined by Heart Rate

    Time frame · until study completion (until 2 days after dose)

    Registry description

    incidence of treatment emergent by measurement of vital signs (heart rate) to determine Safety and Tolerability of Methylene Blue MMX

  4. Safety and Tolerability of Methylene Blue MMX as Determined by Vital Signs (Oxygen Saturation in Peripheral Blood)

    Time frame · until study completion (until 2 days after dose)

    Registry description

    safety and tolerability of Methylene Blue MMX reviewed by incidence of treatment emergent by measurement of vital signs (Oxygen Saturation in peripheral blood)

  5. Safety and Tolerability of Methylene Blue MMX as Determined Body Weight.

    Time frame · until study completion (until 2 days after dose)

    Registry description

    safety and tolerability of Methylene Blue MMX in relation to incidence of treatment emergent by body weight.

  6. Bowel Cleansing Quality-Boston Bowel Preparation Score

    Time frame · One day- bowel cleansing quality is assessed during the colonoscopy procedure

    Registry description

    Bowel cleansing quality evaluated according to the validated Boston Bowel Preparation Scale (BBPS). Colon was divided into 4 target regions: ascending colon (AC), transverse colon (TC), descending colon (DC) and rectosigmoid (RES). Methylene blue staining efficacy was assessed scoring the observed staining percentage as reported below for each colon region: 0 - no staining 1. \- traces (poor traces in colon mucosa) 2. \- detectable (at least the 25% of colon mucosa is stained) 3. \- acceptable (at least the 50% of colon mucosa is stained) 4. \- good (at least the 75% of colon mucosa is stained) 5. \- over stained ( the 100% of the colon mucosa is over stained)

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 outcomeMean· One day- mucosal staining efficacy is assessed during the colonoscopy procedure

Evaluation of Mucosal Staining Efficacy

GroupValue (scores on a scale)Spread
A (Dose:150mg)6.84.0
B (Dose:150mg)2.32.4
C (Dose:150mg)8.13.6
D (Dose:200mg)7.05.0
E (Dose:200mg)9.84.1
F (Dose:200mg)10.54.1
G (Dose 200mg)10.57.8
H (Dose:200mg)10.03.2
I (Dose:200mg)11.43.8
J (Dose:200mg)11.63.5
Secondary and other outcome results(6)
Secondary outcomeMean· until study completion (until 2 days after dose)

Safety and Tolerability of Methylene Blue MMX as Determined by Vital Signs (Blood Pressure)

GroupValue (mmHg)Spread
Pre Colonoscopy - 150mg Dose122.614.6
Pre Colonoscopy- 200mg Dose124.317.7
During Colonoscopy- 150mg Dose122.614.6
During Colonoscopy- 200mg Dose124.317.7
Post Colonoscopy- 150mg Dose122.714.5
Post Colonoscopy- 200mg Dose124.217.7
Secondary outcomeCount of participants· Until study completion (until 2 days after dose)

Safety and Tolerability of Methylene Blue MMX as Determined by AEs

GroupValue (Participants)
Pre Colonoscopy - 150mg Dose3
Pre Colonoscopy- 200mg Dose3
During Colonoscopy- 150mg Dose0
During Colonoscopy- 200mg Dose0
Post Colonoscopy- 150mg Dose0
Post Colonoscopy- 200mg Dose0
Secondary outcomeMean· until study completion (until 2 days after dose)

Safety and Tolerability of Methylene Blue MMX as Determined by Heart Rate

GroupValue (beats per minute (BPM))Spread
Pre Colonoscopy - 150mg Dose73.910.6
Pre Colonoscopy- 200mg Dose75.215.1
During Colonoscopy - 150mg Dose74.310.9
During Colonoscopy- 200mg Dose75.315.1
Post Colonoscopy- 150mg Dose74.210.9
Post Colonoscopy- 200mg Dose7.115.1
Secondary outcomeMean· until study completion (until 2 days after dose)

Safety and Tolerability of Methylene Blue MMX as Determined by Vital Signs (Oxygen Saturation in Peripheral Blood)

GroupValue (percentage of saturation)Spread
Pre Colonoscopy - 150mg Dose98.41.8
Pre Colonoscopy- 200mg Dose98.76.6
During Colonoscopy- 150mg Dose98.41.8
During Colonoscopy- 200mg Dose98.86.5
Post Colonoscopy- 150mg Dose98.41.8
Post Colonoscopy- 200mg Dose98.86.5
Secondary outcomeMean· until study completion (until 2 days after dose)

Safety and Tolerability of Methylene Blue MMX as Determined Body Weight.

GroupValue (Kg)Spread
Visit 1-Screening 150mL67.213.0
Visit 1-Screening 200mL71.315.9
Visit 2-Final 150mL67.413.0
Visit 2-Final 200mL71.215.8
Secondary outcomeMean· One day- bowel cleansing quality is assessed during the colonoscopy procedure

Bowel Cleansing Quality-Boston Bowel Preparation Score

GroupValue (Colon cleansing score)Spread
150 mg Methylene Blue-MMX Tablets5.41.7
200 mg Methylene Blue-MMX Tablets5.41.1
Overall5.41.2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
AEs Methylene Blue-MMX Tablets Equivalent to 150 mgPatients under going Colonoscpy taking Methylene Blue MMX Dose 150mL–0 / 241 / 24
AEs Methylene Blue-MMX Tablets Equivalent to 200 mgPatients under going Colonoscpy taking Methylene Blue MMX dose 200 mg–0 / 882 / 88

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.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Sex: males and females; 2. Age:18 to 70 years; 3. Colonoscopy: out-patients with indication for colonoscopy including faecal occult blood test positive colorectal cancer screening, polypectomy follow-up and inflammatory bowel disease check; 4. Contraception: either sterile subjects or subjects practising at least one reliable methods of contraception or in post-menopausal status for at least 1 year; 5. Informed Consent: signed written informed consent prior to inclusion in the study. Exclusion Criteria: 1. Pregnancy: pregnant or lactating women or at a risk of becoming pregnant; 2. Allergy: known or suspected hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general; 3. Diseases: known or suspected gastrointestinal obstruction or perforation, toxic megacolon, major colonic resection, inflammatory bowel diseases in active phase, severe diverticulosis with diverticulitis, heart failure (Class III or IV), serious cardiovascular disease, severe liver failure, end-stage renal insufficiency, any other relevant disease that might interfere with the aim of the study. 4. Comprehension: inability to comprehend the full nature and purpose of the study and unwillingness to co-operate with the Investigator and to comply with the requirements of the entire study.

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