Trial Outcomes & Findings for Effect of Oral Administration of Methylene Blue MMX Tablets on Double Stranded DNA (NCT NCT02295774)

NCT ID: NCT02295774

Last Updated: 2018-11-05

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2018-11-05

Participant Flow

Participant milestones

Measure	MB MMX 200mg Subjects who have had samples collected during initial colonoscopy, who require a second colonoscopy within 2 weeks. Prior to initial colonoscopy the subjects take 200mg Methylene Blue MMX tablets. Biopsies collected are compared to their initial colonoscopy for histone gamma H2AX activity. Methylene Blue MMX tablets: 8x25mg methylene blue MMX tablets administered before a colonoscopy
Overall Study STARTED	13
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	MB MMX 200mg Subjects who have had samples collected during initial colonoscopy, who require a second colonoscopy within 2 weeks. Prior to initial colonoscopy the subjects take 200mg Methylene Blue MMX tablets. Biopsies collected are compared to their initial colonoscopy for histone gamma H2AX activity. Methylene Blue MMX tablets: 8x25mg methylene blue MMX tablets administered before a colonoscopy
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	MB MMX 200mg n=10 Participants Subjects who have had samples collected during initial 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 initial colonoscopy for histone gamma H2AX activity. Methylene Blue MMX tablets: 8x25mg methylene blue MMX tablets administered before a colonoscopy. Subjects were counted as part of an analysis group once they had received the IMP. The discontinued subjects in this study we discontinued before received the IMP.
Age, Continuous	63.1 Years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment Italy	10 participants n=5 Participants
Body weight	74.40 kg STANDARD_DEVIATION 15.48 • n=5 Participants
Height	168.2 cm STANDARD_DEVIATION 11.2 • n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: FAS = 10

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

Outcome measures

Measure

MB MMX 200mg n=10 Participants Subjects who have had samples collected during initial 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 initial colonoscopy for histone gamma H2AX activity. Methylene Blue MMX tablets: 8x25mg methylene blue MMX tablets administered before a colonoscopy

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

0 subject biopsies that tested + for γH2AX

SECONDARY outcome

Timeframe: During the colonoscopy

Population: Full Analysis Set (FAS): all included subjects, who received at least one dose of the IMP and had at least one biopsy for the evaluation of the level of γH2AX post-enrolment. This analysis set was used for the primary analysis

Staining quality (SC) observed in each colonic region, in the FAS set (N=10); mean (±SD) is reported for SC.

SC is ranked as follows:

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. overstained ( the 100% of the colon mucosa is over stained)

Outcome measures

Measure	MB MMX 200mg n=10 Participants Subjects who have had samples collected during initial 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 initial colonoscopy for histone gamma H2AX activity. Methylene Blue MMX tablets: 8x25mg methylene blue MMX tablets administered before a colonoscopy
To Evaluate the Staining Quality Obtained With Oral Methylene Blue MMX® Tablets. Transverse colon	3.2 Units on a 6 point scale Standard Deviation 0.8
To Evaluate the Staining Quality Obtained With Oral Methylene Blue MMX® Tablets. Ascending colon	2.9 Units on a 6 point scale Standard Deviation 1.3
To Evaluate the Staining Quality Obtained With Oral Methylene Blue MMX® Tablets. Descending colon	2.7 Units on a 6 point scale Standard Deviation 1.2
To Evaluate the Staining Quality Obtained With Oral Methylene Blue MMX® Tablets. Rectosigmoid	2.2 Units on a 6 point scale Standard Deviation 1.6

Adverse Events

MB MMX 200mg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	MB MMX 200mg n=13 participants at risk Biopsy samples collected during standard white light colonoscopy. No study drug was taken prior to initial Colonoscopy (White light only) Subjects who have had samples collected during initial 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 initial colonoscopy for histone gamma H2AX activity. Methylene Blue MMX tablets: 8x25mg methylene blue MMX tablets administered before a colonoscopy
Renal and urinary disorders Chromaturia	61.5% 8/13 • Up to two weeks after IMP administration
Gastrointestinal disorders Faeces discoloured	30.8% 4/13 • Up to two weeks after IMP administration
Nervous system disorders Headache	7.7% 1/13 • Up to two weeks after IMP administration

Additional Information

Alessandro Repici MD

Humanitas Research Hospital & Humanitas University

Phone: 00390282247493

Email: alessandro.repici@hunimed.eu

Results disclosure agreements

• Principal investigator is a sponsor employee PI must send a manuscript to Sponsor prior to its submission for publication. Sponsor will have 60 days after receipt of the manuscript in which to suggest changes. PI will accept to incorporate the publication comments that do not conflict with the reliability of data, with the rights, the safety and welfare of patients. PI retains the right to publish the result of trial in accordance with current legislation with the consent of the Sponsor subject to the rights of intellectual property.
• Publication restrictions are in place

Restriction type: OTHER