Trial Outcomes & Findings for Colon Staining Efficacy of Single Oral Doses of Methylene Blue MMX (NCT NCT03287219)
NCT ID: NCT03287219
Last Updated: 2021-01-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
114 participants
Primary outcome timeframe
One day- mucosal staining efficacy is assessed during the colonoscopy procedure
Results posted on
2021-01-28
Participant Flow
Participant milestones
| Measure |
150 mg Methylene Blue-MMX Tablets
take 6 x 25mg Methylene Blue-MMX tablets equivalent to 150 mg
Methylene Blue MMX 25 mg modified release tablets: Methylene Blue MMX 25 mg modified release tablets administered with a full dose regimen of a 4-L PEG-based bowel cleansing preparation.
|
200 mg Methylene Blue-MMX Tablets
take 8 x 25mg Methylene Blue-MMX tablets equivalent to 200 mg
Methylene Blue MMX 25 mg modified release tablets: Methylene Blue MMX 25 mg modified release tablets administered with a full dose regimen of a 4-L PEG-based bowel cleansing preparation.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
90
|
|
Overall Study
COMPLETED
|
24
|
88
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
150 mg Methylene Blue-MMX Tablets
take 6 x 25mg Methylene Blue-MMX tablets equivalent to 150 mg
Methylene Blue MMX 25 mg modified release tablets: Methylene Blue MMX 25 mg modified release tablets administered with a full dose regimen of a 4-L PEG-based bowel cleansing preparation.
|
200 mg Methylene Blue-MMX Tablets
take 8 x 25mg Methylene Blue-MMX tablets equivalent to 200 mg
Methylene Blue MMX 25 mg modified release tablets: Methylene Blue MMX 25 mg modified release tablets administered with a full dose regimen of a 4-L PEG-based bowel cleansing preparation.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
2
|
Baseline Characteristics
Colon Staining Efficacy of Single Oral Doses of Methylene Blue MMX
Baseline characteristics by cohort
| Measure |
Methylene Blue MMX 150mg
n=24 Participants
Patients under going Colonoscpy taking Methylene Blue-MMX tablets equivalent to 150 mg
|
Methylene Blue MMX 200mg
n=88 Participants
Patients under going Colonoscpy taking Methylene Blue-MMX tablets equivalent to 200 mg
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.4 years
STANDARD_DEVIATION 11.0 • n=93 Participants
|
55.6 years
STANDARD_DEVIATION 11.2 • n=4 Participants
|
54.5 years
STANDARD_DEVIATION 11.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
53 Participants
n=4 Participants
|
66 Participants
n=27 Participants
|
|
Height
|
166.5 Centimetres
STANDARD_DEVIATION 8.4 • n=93 Participants
|
168.5 Centimetres
STANDARD_DEVIATION 8.7 • n=4 Participants
|
167.4 Centimetres
STANDARD_DEVIATION 8.7 • n=27 Participants
|
|
Body Weight
|
68 Kg
STANDARD_DEVIATION 13.3 • n=93 Participants
|
70.6 Kg
STANDARD_DEVIATION 14.2 • n=4 Participants
|
69 Kg
STANDARD_DEVIATION 14.0 • n=27 Participants
|
PRIMARY outcome
Timeframe: One day- mucosal staining efficacy is assessed during the colonoscopy procedureMucosal 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.
Outcome measures
| Measure |
A (Dose:150mg)
n=8 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation:
At the beginning - 2 After the 1st L - 2 After the 2nd L - 2 After the 3rd L - 0 At the end - 0
|
B (Dose:150mg)
n=7 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation:
At the beginning - 6 After the 1st L - 0 After the 2nd L- 0 After the 3rd L- 0 At the end- 0
|
C (Dose:150mg)
n=9 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation:
At the beginning - 0 After the 1st L - 0 After the 2nd L - 0 After the 3rd L - 0 At the end - 6
|
D (Dose:200mg)
n=20 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -4 After the 1st L-2 After the 2nd L-2 After the 3rd L-0 At the end-0
|
E (Dose:200mg)
n=9 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -0 After the 1st L-0 After the 2nd L-0 After the 3rd L-0 At the end-8
|
F (Dose:200mg)
n=8 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -2 After the 1st L-2 After the 2nd L-2 After the 3rd L-0 At the end-2
|
G (Dose 200mg)
n=2 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -4 After the 1st L-2 After the 2nd L-2 After the 3rd L-0 At the end-0
|
H (Dose:200mg)
n=20 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -0 After the 1st L-0 After the 2nd L-0 After the 3rd L-4 At the end-4
|
I (Dose:200mg)
n=16 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -0 After the 1st L-0 After the 2nd L-4 After the 3rd L-4 At the end-0
|
J (Dose:200mg)
n=13 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation:
At the beginning - 0 After the 1st L - 0 After the 2nd L - 2 After the 3rd L - 3 At the end - 3
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Evaluation of Mucosal Staining Efficacy
|
6.8 scores on a scale
Standard Deviation 4.0
|
2.3 scores on a scale
Standard Deviation 2.4
|
8.1 scores on a scale
Standard Deviation 3.6
|
7.0 scores on a scale
Standard Deviation 5.0
|
9.8 scores on a scale
Standard Deviation 4.1
|
10.5 scores on a scale
Standard Deviation 4.1
|
10.5 scores on a scale
Standard Deviation 7.8
|
10.0 scores on a scale
Standard Deviation 3.2
|
11.4 scores on a scale
Standard Deviation 3.8
|
11.6 scores on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: until study completion (until 2 days after dose)Population: Safety population: the safety population was defined as all enrolled subjects who received at least one dose of the study drug. This population was used for safety evaluation
safety and tolerability of Methylene Blue MMX reviewed by incidence of treatment emergent by measurement of vital signs (blood pressure)
Outcome measures
| Measure |
A (Dose:150mg)
n=24 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation:
At the beginning - 2 After the 1st L - 2 After the 2nd L - 2 After the 3rd L - 0 At the end - 0
|
B (Dose:150mg)
n=88 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation:
At the beginning - 6 After the 1st L - 0 After the 2nd L- 0 After the 3rd L- 0 At the end- 0
|
C (Dose:150mg)
n=24 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation:
At the beginning - 0 After the 1st L - 0 After the 2nd L - 0 After the 3rd L - 0 At the end - 6
|
D (Dose:200mg)
n=86 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -4 After the 1st L-2 After the 2nd L-2 After the 3rd L-0 At the end-0
|
E (Dose:200mg)
n=24 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -0 After the 1st L-0 After the 2nd L-0 After the 3rd L-0 At the end-8
|
F (Dose:200mg)
n=87 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -2 After the 1st L-2 After the 2nd L-2 After the 3rd L-0 At the end-2
|
G (Dose 200mg)
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -4 After the 1st L-2 After the 2nd L-2 After the 3rd L-0 At the end-0
|
H (Dose:200mg)
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -0 After the 1st L-0 After the 2nd L-0 After the 3rd L-4 At the end-4
|
I (Dose:200mg)
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -0 After the 1st L-0 After the 2nd L-4 After the 3rd L-4 At the end-0
|
J (Dose:200mg)
Number of tablets taken in relation to the intake of the bowel cleansing preparation:
At the beginning - 0 After the 1st L - 0 After the 2nd L - 2 After the 3rd L - 3 At the end - 3
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of Methylene Blue MMX as Determined by Vital Signs (Blood Pressure)
Systolic Blood Pressure (mmHg)
|
122.6 mmHg
Standard Deviation 14.6
|
124.3 mmHg
Standard Deviation 17.7
|
122.6 mmHg
Standard Deviation 14.6
|
124.3 mmHg
Standard Deviation 17.7
|
122.7 mmHg
Standard Deviation 14.5
|
124.2 mmHg
Standard Deviation 17.7
|
—
|
—
|
—
|
—
|
|
Safety and Tolerability of Methylene Blue MMX as Determined by Vital Signs (Blood Pressure)
Diastolic Blood Pressure(mmHg)
|
74.7 mmHg
Standard Deviation 8.1
|
74.0 mmHg
Standard Deviation 11.9
|
74.9 mmHg
Standard Deviation 8.2
|
74.0 mmHg
Standard Deviation 11.9
|
75 mmHg
Standard Deviation 8.2
|
74.0 mmHg
Standard Deviation 11.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Until study completion (until 2 days after dose)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.
Outcome measures
| Measure |
A (Dose:150mg)
n=24 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation:
At the beginning - 2 After the 1st L - 2 After the 2nd L - 2 After the 3rd L - 0 At the end - 0
|
B (Dose:150mg)
n=88 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation:
At the beginning - 6 After the 1st L - 0 After the 2nd L- 0 After the 3rd L- 0 At the end- 0
|
C (Dose:150mg)
n=24 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation:
At the beginning - 0 After the 1st L - 0 After the 2nd L - 0 After the 3rd L - 0 At the end - 6
|
D (Dose:200mg)
n=86 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -4 After the 1st L-2 After the 2nd L-2 After the 3rd L-0 At the end-0
|
E (Dose:200mg)
n=24 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -0 After the 1st L-0 After the 2nd L-0 After the 3rd L-0 At the end-8
|
F (Dose:200mg)
n=87 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -2 After the 1st L-2 After the 2nd L-2 After the 3rd L-0 At the end-2
|
G (Dose 200mg)
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -4 After the 1st L-2 After the 2nd L-2 After the 3rd L-0 At the end-0
|
H (Dose:200mg)
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -0 After the 1st L-0 After the 2nd L-0 After the 3rd L-4 At the end-4
|
I (Dose:200mg)
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -0 After the 1st L-0 After the 2nd L-4 After the 3rd L-4 At the end-0
|
J (Dose:200mg)
Number of tablets taken in relation to the intake of the bowel cleansing preparation:
At the beginning - 0 After the 1st L - 0 After the 2nd L - 2 After the 3rd L - 3 At the end - 3
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of Methylene Blue MMX as Determined by AEs
|
3 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: until study completion (until 2 days after dose)Population: Safety population: the safety population was defined as all enrolled subjects who received at least one dose of the study drug. This population was used for safety evaluation
incidence of treatment emergent by measurement of vital signs (heart rate) to determine Safety and Tolerability of Methylene Blue MMX
Outcome measures
| Measure |
A (Dose:150mg)
n=24 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation:
At the beginning - 2 After the 1st L - 2 After the 2nd L - 2 After the 3rd L - 0 At the end - 0
|
B (Dose:150mg)
n=87 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation:
At the beginning - 6 After the 1st L - 0 After the 2nd L- 0 After the 3rd L- 0 At the end- 0
|
C (Dose:150mg)
n=24 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation:
At the beginning - 0 After the 1st L - 0 After the 2nd L - 0 After the 3rd L - 0 At the end - 6
|
D (Dose:200mg)
n=85 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -4 After the 1st L-2 After the 2nd L-2 After the 3rd L-0 At the end-0
|
E (Dose:200mg)
n=24 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -0 After the 1st L-0 After the 2nd L-0 After the 3rd L-0 At the end-8
|
F (Dose:200mg)
n=87 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -2 After the 1st L-2 After the 2nd L-2 After the 3rd L-0 At the end-2
|
G (Dose 200mg)
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -4 After the 1st L-2 After the 2nd L-2 After the 3rd L-0 At the end-0
|
H (Dose:200mg)
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -0 After the 1st L-0 After the 2nd L-0 After the 3rd L-4 At the end-4
|
I (Dose:200mg)
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -0 After the 1st L-0 After the 2nd L-4 After the 3rd L-4 At the end-0
|
J (Dose:200mg)
Number of tablets taken in relation to the intake of the bowel cleansing preparation:
At the beginning - 0 After the 1st L - 0 After the 2nd L - 2 After the 3rd L - 3 At the end - 3
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of Methylene Blue MMX as Determined by Heart Rate
|
73.9 beats per minute (BPM)
Standard Deviation 10.6
|
75.2 beats per minute (BPM)
Standard Deviation 15.1
|
74.3 beats per minute (BPM)
Standard Deviation 10.9
|
75.3 beats per minute (BPM)
Standard Deviation 15.1
|
74.2 beats per minute (BPM)
Standard Deviation 10.9
|
7.1 beats per minute (BPM)
Standard Deviation 15.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: until study completion (until 2 days after dose)Population: Safety population: the safety population was defined as all enrolled subjects who received at least one dose of the study drug. This population was used for safety evaluation
safety and tolerability of Methylene Blue MMX reviewed by incidence of treatment emergent by measurement of vital signs (Oxygen Saturation in peripheral blood)
Outcome measures
| Measure |
A (Dose:150mg)
n=24 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation:
At the beginning - 2 After the 1st L - 2 After the 2nd L - 2 After the 3rd L - 0 At the end - 0
|
B (Dose:150mg)
n=88 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation:
At the beginning - 6 After the 1st L - 0 After the 2nd L- 0 After the 3rd L- 0 At the end- 0
|
C (Dose:150mg)
n=24 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation:
At the beginning - 0 After the 1st L - 0 After the 2nd L - 0 After the 3rd L - 0 At the end - 6
|
D (Dose:200mg)
n=86 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -4 After the 1st L-2 After the 2nd L-2 After the 3rd L-0 At the end-0
|
E (Dose:200mg)
n=24 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -0 After the 1st L-0 After the 2nd L-0 After the 3rd L-0 At the end-8
|
F (Dose:200mg)
n=87 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -2 After the 1st L-2 After the 2nd L-2 After the 3rd L-0 At the end-2
|
G (Dose 200mg)
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -4 After the 1st L-2 After the 2nd L-2 After the 3rd L-0 At the end-0
|
H (Dose:200mg)
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -0 After the 1st L-0 After the 2nd L-0 After the 3rd L-4 At the end-4
|
I (Dose:200mg)
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -0 After the 1st L-0 After the 2nd L-4 After the 3rd L-4 At the end-0
|
J (Dose:200mg)
Number of tablets taken in relation to the intake of the bowel cleansing preparation:
At the beginning - 0 After the 1st L - 0 After the 2nd L - 2 After the 3rd L - 3 At the end - 3
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of Methylene Blue MMX as Determined by Vital Signs (Oxygen Saturation in Peripheral Blood)
|
98.4 percentage of saturation
Standard Deviation 1.8
|
98.7 percentage of saturation
Standard Deviation 6.6
|
98.4 percentage of saturation
Standard Deviation 1.8
|
98.8 percentage of saturation
Standard Deviation 6.5
|
98.4 percentage of saturation
Standard Deviation 1.8
|
98.8 percentage of saturation
Standard Deviation 6.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: until study completion (until 2 days after dose)safety and tolerability of Methylene Blue MMX in relation to incidence of treatment emergent by body weight.
Outcome measures
| Measure |
A (Dose:150mg)
n=24 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation:
At the beginning - 2 After the 1st L - 2 After the 2nd L - 2 After the 3rd L - 0 At the end - 0
|
B (Dose:150mg)
n=89 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation:
At the beginning - 6 After the 1st L - 0 After the 2nd L- 0 After the 3rd L- 0 At the end- 0
|
C (Dose:150mg)
n=24 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation:
At the beginning - 0 After the 1st L - 0 After the 2nd L - 0 After the 3rd L - 0 At the end - 6
|
D (Dose:200mg)
n=89 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -4 After the 1st L-2 After the 2nd L-2 After the 3rd L-0 At the end-0
|
E (Dose:200mg)
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -0 After the 1st L-0 After the 2nd L-0 After the 3rd L-0 At the end-8
|
F (Dose:200mg)
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -2 After the 1st L-2 After the 2nd L-2 After the 3rd L-0 At the end-2
|
G (Dose 200mg)
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -4 After the 1st L-2 After the 2nd L-2 After the 3rd L-0 At the end-0
|
H (Dose:200mg)
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -0 After the 1st L-0 After the 2nd L-0 After the 3rd L-4 At the end-4
|
I (Dose:200mg)
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -0 After the 1st L-0 After the 2nd L-4 After the 3rd L-4 At the end-0
|
J (Dose:200mg)
Number of tablets taken in relation to the intake of the bowel cleansing preparation:
At the beginning - 0 After the 1st L - 0 After the 2nd L - 2 After the 3rd L - 3 At the end - 3
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of Methylene Blue MMX as Determined Body Weight.
|
67.2 Kg
Standard Deviation 13.0
|
71.3 Kg
Standard Deviation 15.9
|
67.4 Kg
Standard Deviation 13.0
|
71.2 Kg
Standard Deviation 15.8
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One day- bowel cleansing quality is assessed during the colonoscopy procedureBowel 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)
Outcome measures
| Measure |
A (Dose:150mg)
n=24 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation:
At the beginning - 2 After the 1st L - 2 After the 2nd L - 2 After the 3rd L - 0 At the end - 0
|
B (Dose:150mg)
n=88 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation:
At the beginning - 6 After the 1st L - 0 After the 2nd L- 0 After the 3rd L- 0 At the end- 0
|
C (Dose:150mg)
n=112 Participants
Number of tablets taken in relation to the intake of the bowel cleansing preparation:
At the beginning - 0 After the 1st L - 0 After the 2nd L - 0 After the 3rd L - 0 At the end - 6
|
D (Dose:200mg)
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -4 After the 1st L-2 After the 2nd L-2 After the 3rd L-0 At the end-0
|
E (Dose:200mg)
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -0 After the 1st L-0 After the 2nd L-0 After the 3rd L-0 At the end-8
|
F (Dose:200mg)
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -2 After the 1st L-2 After the 2nd L-2 After the 3rd L-0 At the end-2
|
G (Dose 200mg)
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -4 After the 1st L-2 After the 2nd L-2 After the 3rd L-0 At the end-0
|
H (Dose:200mg)
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -0 After the 1st L-0 After the 2nd L-0 After the 3rd L-4 At the end-4
|
I (Dose:200mg)
Number of tablets taken in relation to the intake of the bowel cleansing preparation At the beginning -0 After the 1st L-0 After the 2nd L-4 After the 3rd L-4 At the end-0
|
J (Dose:200mg)
Number of tablets taken in relation to the intake of the bowel cleansing preparation:
At the beginning - 0 After the 1st L - 0 After the 2nd L - 2 After the 3rd L - 3 At the end - 3
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Bowel Cleansing Quality-Boston Bowel Preparation Score
|
5.4 Colon cleansing score
Standard Deviation 1.7
|
5.4 Colon cleansing score
Standard Deviation 1.1
|
5.4 Colon cleansing score
Standard Deviation 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
AEs Methylene Blue-MMX Tablets Equivalent to 150 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
AEs Methylene Blue-MMX Tablets Equivalent to 200 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AEs Methylene Blue-MMX Tablets Equivalent to 150 mg
n=24 participants at risk
Patients under going Colonoscpy taking Methylene Blue MMX Dose 150mL
|
AEs Methylene Blue-MMX Tablets Equivalent to 200 mg
n=88 participants at risk
Patients under going Colonoscpy taking Methylene Blue MMX dose 200 mg
|
|---|---|---|
|
Gastrointestinal disorders
vomiting
|
4.2%
1/24 • Number of events 3
|
2.3%
2/88 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place