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| Name | Class |
|---|---|
| Cross S.A. | INDUSTRY |
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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.
Objectives:
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.
Primary end-point(s):
To evaluate the mucosal staining efficacy of Methylene Blue MMX® tablets after total oral doses of 150 or 200 mg.
Secondary end-point(s):
Bowel cleansing quality evaluated according to the validated Boston Bowel Preparation Scale (BBPS) after intake of 150 or 200 mg of Methylene Blue MMX® tablets during the intake of the bowel cleansing preparation.
To collect data about safety and tolerability of Methylene Blue MMX® tablets after administration of single oral doses of 150 or 200 mg.
Methodology:
Open label, staining efficacy exploratory study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 150 mg Methylene Blue-MMX tablets | Active Comparator | take 6 x 25mg Methylene Blue-MMX tablets equivalent to 150 mg |
|
| 200 mg Methylene Blue-MMX tablets | Active Comparator | take 8 x 25mg Methylene Blue-MMX tablets equivalent to 200 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylene Blue MMX 25 mg modified release tablets | Drug | Methylene Blue MMX 25 mg modified release tablets administered with a full dose regimen of a 4-L PEG-based bowel cleansing preparation. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Mucosal Staining Efficacy | 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
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. | One day- mucosal staining efficacy is assessed during the colonoscopy procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of Methylene Blue MMX as Determined by Vital Signs (Blood Pressure) | safety and tolerability of Methylene Blue MMX reviewed by incidence of treatment emergent by measurement of vital signs (blood pressure) | until study completion (until 2 days after dose) |
| Safety and Tolerability of Methylene Blue MMX as Determined by AEs |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Methylene Blue MMX 150mg | Patients under going Colonoscpy taking Methylene Blue-MMX tablets equivalent to 150 mg |
| BG001 | Methylene Blue MMX 200mg | Patients under going Colonoscpy taking Methylene Blue-MMX tablets equivalent to 200 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evaluation of Mucosal Staining Efficacy | 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
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. | Posted | Mean | Standard Deviation | scores on a scale | One day- mucosal staining efficacy is assessed during the colonoscopy procedure |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AEs Methylene Blue-MMX Tablets Equivalent to 150 mg | Patients under going Colonoscpy taking Methylene Blue MMX Dose 150mL |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vomiting | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| R&D Manager | Cosmo Technologies Ltd | rjones@cosmopharma.com |
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Open label, staining efficacy exploratory study.
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None. Open label
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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. |
| Until study completion (until 2 days after dose) |
| Safety and Tolerability of Methylene Blue MMX as Determined by Heart Rate | incidence of treatment emergent by measurement of vital signs (heart rate) to determine Safety and Tolerability of Methylene Blue MMX | 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) | safety and tolerability of Methylene Blue MMX reviewed by incidence of treatment emergent by measurement of vital signs (Oxygen Saturation in peripheral blood) | until study completion (until 2 days after dose) |
| Safety and Tolerability of Methylene Blue MMX as Determined Body Weight. | safety and tolerability of Methylene Blue MMX in relation to incidence of treatment emergent by body weight. | until study completion (until 2 days after dose) |
| Bowel Cleansing Quality-Boston Bowel Preparation Score | 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
| One day- bowel cleansing quality is assessed during the colonoscopy procedure |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | Centimetres |
|
| Body Weight | Mean | Standard Deviation | Kg |
|
| OG000 |
| A (Dose:150mg) |
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 |
| OG001 | B (Dose:150mg) | 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 |
| OG002 | C (Dose:150mg) | 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 |
| OG003 | 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 |
| OG004 | 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 |
| OG005 | 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 |
| OG006 | 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 |
| OG007 | 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 |
| OG008 | 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 |
| OG009 | 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 |
|
|
| Secondary | Safety and Tolerability of Methylene Blue MMX as Determined by Vital Signs (Blood Pressure) | safety and tolerability of Methylene Blue MMX reviewed by incidence of treatment emergent by measurement of vital signs (blood pressure) | 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 | Posted | Mean | Standard Deviation | mmHg | until study completion (until 2 days after dose) |
|
|
|
| Secondary | Safety and Tolerability of Methylene Blue MMX as Determined by AEs | 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. | Posted | Count of Participants | Participants | Until study completion (until 2 days after dose) |
|
|
|
| Secondary | Safety and Tolerability of Methylene Blue MMX as Determined by Heart Rate | incidence of treatment emergent by measurement of vital signs (heart rate) to determine Safety and Tolerability of Methylene Blue MMX | 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 | Posted | Mean | Standard Deviation | beats per minute (BPM) | until study completion (until 2 days after dose) |
|
|
|
| Secondary | Safety and Tolerability of Methylene Blue MMX as Determined by Vital Signs (Oxygen Saturation in Peripheral Blood) | safety and tolerability of Methylene Blue MMX reviewed by incidence of treatment emergent by measurement of vital signs (Oxygen Saturation in peripheral blood) | 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 | Posted | Mean | Standard Deviation | percentage of saturation | until study completion (until 2 days after dose) |
|
|
|
| Secondary | Safety and Tolerability of Methylene Blue MMX as Determined Body Weight. | safety and tolerability of Methylene Blue MMX in relation to incidence of treatment emergent by body weight. | Posted | Mean | Standard Deviation | Kg | until study completion (until 2 days after dose) |
|
|
|
| Secondary | Bowel Cleansing Quality-Boston Bowel Preparation Score | 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
| Posted | Mean | Standard Deviation | Colon cleansing score | One day- bowel cleansing quality is assessed during the colonoscopy procedure |
|
|
|
| 0 |
| 24 |
| 1 |
| 24 |
| EG001 | AEs Methylene Blue-MMX Tablets Equivalent to 200 mg | Patients under going Colonoscpy taking Methylene Blue MMX dose 200 mg | 0 | 88 | 2 | 88 |
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| Diastolic Blood Pressure(mmHg) |
|