Trial Outcomes & Findings for The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy (NCT NCT01694966)
NCT ID: NCT01694966
Last Updated: 2017-11-06
Results Overview
Adenoma Detection Rate
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1249 participants
Primary outcome timeframe
+7 days
Results posted on
2017-11-06
Participant Flow
Participant milestones
| Measure |
Methylene Blue MMX® 200mg
Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule
Methylene Blue MMX®
|
Methylene Blue MMX® 100mg
Oral 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.
|
Placebo
Oral dose, 8 Placebo tablets over a 4hr schedule
Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet.
|
|---|---|---|---|
|
Overall Study
STARTED
|
504
|
247
|
498
|
|
Overall Study
COMPLETED
|
470
|
232
|
464
|
|
Overall Study
NOT COMPLETED
|
34
|
15
|
34
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ITT=1249, FAS=1205
Baseline characteristics by cohort
| Measure |
Methylene Blue MMX® 200mg
n=504 Participants
Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule
Methylene Blue MMX®
|
Methylene Blue MMX® 100mg
n=247 Participants
Oral 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.
|
Placebo
n=498 Participants
Oral dose, 8 Placebo tablets over a 4hr schedule
Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet.
|
Total
n=1249 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=485 Participants • ITT=1249, FAS=1205
|
0 Participants
n=241 Participants • ITT=1249, FAS=1205
|
0 Participants
n=479 Participants • ITT=1249, FAS=1205
|
0 Participants
n=1205 Participants • ITT=1249, FAS=1205
|
|
Age, Categorical
Between 18 and 65 years
|
313 Participants
n=485 Participants • ITT=1249, FAS=1205
|
163 Participants
n=241 Participants • ITT=1249, FAS=1205
|
298 Participants
n=479 Participants • ITT=1249, FAS=1205
|
774 Participants
n=1205 Participants • ITT=1249, FAS=1205
|
|
Age, Categorical
>=65 years
|
172 Participants
n=485 Participants • ITT=1249, FAS=1205
|
78 Participants
n=241 Participants • ITT=1249, FAS=1205
|
181 Participants
n=479 Participants • ITT=1249, FAS=1205
|
431 Participants
n=1205 Participants • ITT=1249, FAS=1205
|
|
Sex: Female, Male
Female
|
191 Participants
n=485 Participants • ITT=1249 FAS=1205
|
103 Participants
n=241 Participants • ITT=1249 FAS=1205
|
184 Participants
n=479 Participants • ITT=1249 FAS=1205
|
478 Participants
n=1205 Participants • ITT=1249 FAS=1205
|
|
Sex: Female, Male
Male
|
294 Participants
n=485 Participants • ITT=1249 FAS=1205
|
138 Participants
n=241 Participants • ITT=1249 FAS=1205
|
295 Participants
n=479 Participants • ITT=1249 FAS=1205
|
727 Participants
n=1205 Participants • ITT=1249 FAS=1205
|
PRIMARY outcome
Timeframe: +7 daysPopulation: FAS
Adenoma Detection Rate
Outcome measures
| Measure |
Methylene Blue MMX® 200mg
n=485 Participants
Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule
Methylene Blue MMX®
|
Methylene Blue MMX® 100mg
n=241 Participants
Oral 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.
|
Placebo
n=479 Participants
Oral dose, 8 Placebo tablets over a 4hr schedule
Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet.
|
|---|---|---|---|
|
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.
|
56.3 percentage of participants
|
51.5 percentage of participants
|
47.8 percentage of participants
|
Adverse Events
Methylene Blue MMX® 200mg
Serious events: 1 serious events
Other events: 234 other events
Deaths: 0 deaths
Methylene Blue MMX® 100mg
Serious events: 1 serious events
Other events: 102 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Methylene Blue MMX® 200mg
n=488 participants at risk；n=485 participants at risk
Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule
Methylene Blue MMX®
|
Methylene Blue MMX® 100mg
n=241 participants at risk
Oral 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.
|
Placebo
n=479 participants at risk
Oral dose, 8 Placebo tablets over a 4hr schedule
Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet.
|
|---|---|---|---|
|
Infections and infestations
viral bronchitis
|
0.21%
1/485 • Number of events 1
|
0.00%
0/241
|
0.00%
0/479
|
|
Gastrointestinal disorders
haematochezia
|
0.00%
0/485
|
0.41%
1/241 • Number of events 1
|
0.00%
0/479
|
Other adverse events
| Measure |
Methylene Blue MMX® 200mg
n=488 participants at risk；n=485 participants at risk
Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule
Methylene Blue MMX®
|
Methylene Blue MMX® 100mg
n=241 participants at risk
Oral 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.
|
Placebo
n=479 participants at risk
Oral dose, 8 Placebo tablets over a 4hr schedule
Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet.
|
|---|---|---|---|
|
Gastrointestinal disorders
faeces discoloured
|
19.5%
95/488 • Number of events 95
|
17.8%
43/241 • Number of events 43
|
0.00%
0/479
|
|
Renal and urinary disorders
chromaturia
|
48.0%
234/488 • Number of events 234
|
42.3%
102/241 • Number of events 102
|
1.5%
7/479 • Number of events 7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publications to be reviewed by sponsor prior to submission.
- Publication restrictions are in place
Restriction type: OTHER