Trial Outcomes & Findings for Dose-Finding Safety Study Evaluating Remimazolam (CNS 7056) in Patients Undergoing Diagnostic Upper GI Endoscopy (NCT NCT00869440)
NCT ID: NCT00869440
Last Updated: 2019-01-08
Results Overview
Success of the procedure is a composite endpoint consisting of: MOAA/S scores ≤4 on three consecutive measurements after administration of study drug AND completion of the endoscopy procedure AND no requirement for rescue sedative medication AND no requirement for manual or mechanical ventilation
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
From start of study drug injection to patient discharge
Results posted on
2019-01-08
Participant Flow
Participant milestones
| Measure |
1: CNS 7056 0.10 mg/kg
CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
|
2: CNS 7056 0.15 mg/kg
CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
|
3: CNS 7056 0.20 mg/kg
CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
|
4: Midazolam 0.075 mg/kg
Midazolam: Administered as a single intravenous injection by a syringe driver over 1 minute
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
25
|
25
|
|
Overall Study
COMPLETED
|
23
|
24
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
1: CNS 7056 0.10 mg/kg
CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
|
2: CNS 7056 0.15 mg/kg
CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
|
3: CNS 7056 0.20 mg/kg
CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
|
4: Midazolam 0.075 mg/kg
Midazolam: Administered as a single intravenous injection by a syringe driver over 1 minute
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Dose-Finding Safety Study Evaluating Remimazolam (CNS 7056) in Patients Undergoing Diagnostic Upper GI Endoscopy
Baseline characteristics by cohort
| Measure |
1: CNS 7056 0.10 mg/kg
n=25 Participants
CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
|
2: CNS 7056 0.15 mg/kg
n=25 Participants
CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
|
3: CNS 7056 0.20 mg/kg
n=25 Participants
CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
|
4: Midazolam 0.075 mg/kg
n=25 Participants
Midazolam: Administered as a single intravenous injection by a syringe driver over 1 minute
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 13.33 • n=5 Participants
|
38.8 years
STANDARD_DEVIATION 14.08 • n=7 Participants
|
43.2 years
STANDARD_DEVIATION 13.95 • n=5 Participants
|
44.6 years
STANDARD_DEVIATION 13.64 • n=4 Participants
|
41.1 years
STANDARD_DEVIATION 13.86 • n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
25 participants
n=5 Participants
|
25 participants
n=4 Participants
|
100 participants
n=21 Participants
|
|
Height
|
169.33 cm
STANDARD_DEVIATION 9.603 • n=5 Participants
|
168.42 cm
STANDARD_DEVIATION 10.283 • n=7 Participants
|
168.97 cm
STANDARD_DEVIATION 7.432 • n=5 Participants
|
171.55 cm
STANDARD_DEVIATION 9.650 • n=4 Participants
|
169.57 cm
STANDARD_DEVIATION 9.241 • n=21 Participants
|
|
Weight
|
73.22 kg
STANDARD_DEVIATION 10.583 • n=5 Participants
|
75.17 kg
STANDARD_DEVIATION 10.869 • n=7 Participants
|
75.13 kg
STANDARD_DEVIATION 11.027 • n=5 Participants
|
75.45 kg
STANDARD_DEVIATION 10.099 • n=4 Participants
|
74.74 kg
STANDARD_DEVIATION 10.526 • n=21 Participants
|
|
Body Mass Index (BMI)
|
25.47 Kg/m2
STANDARD_DEVIATION 2.091 • n=5 Participants
|
26.43 Kg/m2
STANDARD_DEVIATION 2.158 • n=7 Participants
|
26.24 Kg/m2
STANDARD_DEVIATION 2.725 • n=5 Participants
|
25.59 Kg/m2
STANDARD_DEVIATION 2.262 • n=4 Participants
|
25.93 Kg/m2
STANDARD_DEVIATION 2.324 • n=21 Participants
|
PRIMARY outcome
Timeframe: From start of study drug injection to patient dischargePopulation: All randomized patients who received a dose of study drug, underwent the endoscopy procedure, and had at least 1 efficacy assessment (Intent-to-treat population)
Success of the procedure is a composite endpoint consisting of: MOAA/S scores ≤4 on three consecutive measurements after administration of study drug AND completion of the endoscopy procedure AND no requirement for rescue sedative medication AND no requirement for manual or mechanical ventilation
Outcome measures
| Measure |
1: CNS 7056 0.10 mg/kg
n=25 Participants
CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
|
2: CNS 7056 0.15 mg/kg
n=25 Participants
CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
|
3: CNS 7056 0.20 mg/kg
n=25 Participants
CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
|
4: Midazolam 0.075 mg/kg
n=25 Participants
Midazolam: Administered as a single intravenous injection by a syringe driver over 1 minute
|
|---|---|---|---|---|
|
Success Rates of the Procedure
|
8 Participants
|
14 Participants
|
16 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: From study drug administration until fully alert criteria are reachedPopulation: All randomized patients who received a dose of study drug, underwent the endoscopy procedure, and had at least 1 efficacy assessment (Intent-to-treat population)
Time to first of 3 consecutive Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores of 5 following study drug administration in patients who underwent the endoscopy procedure
Outcome measures
| Measure |
1: CNS 7056 0.10 mg/kg
n=25 Participants
CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
|
2: CNS 7056 0.15 mg/kg
n=25 Participants
CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
|
3: CNS 7056 0.20 mg/kg
n=25 Participants
CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
|
4: Midazolam 0.075 mg/kg
n=25 Participants
Midazolam: Administered as a single intravenous injection by a syringe driver over 1 minute
|
|---|---|---|---|---|
|
Time to Fully Alert
|
11 minutes
Standard Deviation 10.04
|
13.4 minutes
Standard Deviation 6.51
|
12.1 minutes
Standard Deviation 5.26
|
17.2 minutes
Standard Deviation 16.71
|
SECONDARY outcome
Timeframe: From the end of the endoscopy procedure up to 120 minutes or until 3 consecutive Aldrete scores of ≥9 are reached, whichever occurs firstPopulation: All randomized patients who received a dose of study drug, underwent the endoscopy procedure, and had at least 1 efficacy assessment (Intent-to-treat population)
Time to first of 3 consecutive Aldrete scores ≥9 after the end endoscopy procedure
Outcome measures
| Measure |
1: CNS 7056 0.10 mg/kg
n=25 Participants
CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
|
2: CNS 7056 0.15 mg/kg
n=25 Participants
CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
|
3: CNS 7056 0.20 mg/kg
n=25 Participants
CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
|
4: Midazolam 0.075 mg/kg
n=25 Participants
Midazolam: Administered as a single intravenous injection by a syringe driver over 1 minute
|
|---|---|---|---|---|
|
Time to Ready for Discharge
|
14 minutes
Standard Deviation 9.96
|
12.8 minutes
Standard Deviation 5.96
|
11.8 minutes
Standard Deviation 4.96
|
17.2 minutes
Standard Deviation 12.81
|
Adverse Events
1: CNS 7056 0.10 mg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
2: CNS 7056 0.15 mg/kg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
3: CNS 7056 0.20 mg/kg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
4: Midazolam 0.075 mg/kg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1: CNS 7056 0.10 mg/kg
n=25 participants at risk
CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
|
2: CNS 7056 0.15 mg/kg
n=25 participants at risk
CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
|
3: CNS 7056 0.20 mg/kg
n=25 participants at risk
CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
|
4: Midazolam 0.075 mg/kg
n=25 participants at risk
Midazolam: Administered as a single intravenous injection by a syringe driver over 1 minute
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/25 • Treatment-emergent adverse events (TEAEs) were collected from Time 0 on Day 1 to the Follow-up Visit on Day 4, and were followed until resolution (with or without sequelae) up to a maximum of 30 days after Time 0.
Total number of participants affected with Other (Not Including Serious) Adverse Events represents overall number of participants with non-serious TEAEs reported with a threshold of 5% in any of the arms
|
0.00%
0/25 • Treatment-emergent adverse events (TEAEs) were collected from Time 0 on Day 1 to the Follow-up Visit on Day 4, and were followed until resolution (with or without sequelae) up to a maximum of 30 days after Time 0.
Total number of participants affected with Other (Not Including Serious) Adverse Events represents overall number of participants with non-serious TEAEs reported with a threshold of 5% in any of the arms
|
8.0%
2/25 • Treatment-emergent adverse events (TEAEs) were collected from Time 0 on Day 1 to the Follow-up Visit on Day 4, and were followed until resolution (with or without sequelae) up to a maximum of 30 days after Time 0.
Total number of participants affected with Other (Not Including Serious) Adverse Events represents overall number of participants with non-serious TEAEs reported with a threshold of 5% in any of the arms
|
0.00%
0/25 • Treatment-emergent adverse events (TEAEs) were collected from Time 0 on Day 1 to the Follow-up Visit on Day 4, and were followed until resolution (with or without sequelae) up to a maximum of 30 days after Time 0.
Total number of participants affected with Other (Not Including Serious) Adverse Events represents overall number of participants with non-serious TEAEs reported with a threshold of 5% in any of the arms
|
|
Investigations
Oxygen saturation decreased
|
16.0%
4/25 • Treatment-emergent adverse events (TEAEs) were collected from Time 0 on Day 1 to the Follow-up Visit on Day 4, and were followed until resolution (with or without sequelae) up to a maximum of 30 days after Time 0.
Total number of participants affected with Other (Not Including Serious) Adverse Events represents overall number of participants with non-serious TEAEs reported with a threshold of 5% in any of the arms
|
20.0%
5/25 • Treatment-emergent adverse events (TEAEs) were collected from Time 0 on Day 1 to the Follow-up Visit on Day 4, and were followed until resolution (with or without sequelae) up to a maximum of 30 days after Time 0.
Total number of participants affected with Other (Not Including Serious) Adverse Events represents overall number of participants with non-serious TEAEs reported with a threshold of 5% in any of the arms
|
24.0%
6/25 • Treatment-emergent adverse events (TEAEs) were collected from Time 0 on Day 1 to the Follow-up Visit on Day 4, and were followed until resolution (with or without sequelae) up to a maximum of 30 days after Time 0.
Total number of participants affected with Other (Not Including Serious) Adverse Events represents overall number of participants with non-serious TEAEs reported with a threshold of 5% in any of the arms
|
20.0%
5/25 • Treatment-emergent adverse events (TEAEs) were collected from Time 0 on Day 1 to the Follow-up Visit on Day 4, and were followed until resolution (with or without sequelae) up to a maximum of 30 days after Time 0.
Total number of participants affected with Other (Not Including Serious) Adverse Events represents overall number of participants with non-serious TEAEs reported with a threshold of 5% in any of the arms
|
|
Nervous system disorders
Dizziness
|
0.00%
0/25 • Treatment-emergent adverse events (TEAEs) were collected from Time 0 on Day 1 to the Follow-up Visit on Day 4, and were followed until resolution (with or without sequelae) up to a maximum of 30 days after Time 0.
Total number of participants affected with Other (Not Including Serious) Adverse Events represents overall number of participants with non-serious TEAEs reported with a threshold of 5% in any of the arms
|
0.00%
0/25 • Treatment-emergent adverse events (TEAEs) were collected from Time 0 on Day 1 to the Follow-up Visit on Day 4, and were followed until resolution (with or without sequelae) up to a maximum of 30 days after Time 0.
Total number of participants affected with Other (Not Including Serious) Adverse Events represents overall number of participants with non-serious TEAEs reported with a threshold of 5% in any of the arms
|
0.00%
0/25 • Treatment-emergent adverse events (TEAEs) were collected from Time 0 on Day 1 to the Follow-up Visit on Day 4, and were followed until resolution (with or without sequelae) up to a maximum of 30 days after Time 0.
Total number of participants affected with Other (Not Including Serious) Adverse Events represents overall number of participants with non-serious TEAEs reported with a threshold of 5% in any of the arms
|
8.0%
2/25 • Treatment-emergent adverse events (TEAEs) were collected from Time 0 on Day 1 to the Follow-up Visit on Day 4, and were followed until resolution (with or without sequelae) up to a maximum of 30 days after Time 0.
Total number of participants affected with Other (Not Including Serious) Adverse Events represents overall number of participants with non-serious TEAEs reported with a threshold of 5% in any of the arms
|
|
Nervous system disorders
Headache
|
8.0%
2/25 • Treatment-emergent adverse events (TEAEs) were collected from Time 0 on Day 1 to the Follow-up Visit on Day 4, and were followed until resolution (with or without sequelae) up to a maximum of 30 days after Time 0.
Total number of participants affected with Other (Not Including Serious) Adverse Events represents overall number of participants with non-serious TEAEs reported with a threshold of 5% in any of the arms
|
8.0%
2/25 • Treatment-emergent adverse events (TEAEs) were collected from Time 0 on Day 1 to the Follow-up Visit on Day 4, and were followed until resolution (with or without sequelae) up to a maximum of 30 days after Time 0.
Total number of participants affected with Other (Not Including Serious) Adverse Events represents overall number of participants with non-serious TEAEs reported with a threshold of 5% in any of the arms
|
8.0%
2/25 • Treatment-emergent adverse events (TEAEs) were collected from Time 0 on Day 1 to the Follow-up Visit on Day 4, and were followed until resolution (with or without sequelae) up to a maximum of 30 days after Time 0.
Total number of participants affected with Other (Not Including Serious) Adverse Events represents overall number of participants with non-serious TEAEs reported with a threshold of 5% in any of the arms
|
8.0%
2/25 • Treatment-emergent adverse events (TEAEs) were collected from Time 0 on Day 1 to the Follow-up Visit on Day 4, and were followed until resolution (with or without sequelae) up to a maximum of 30 days after Time 0.
Total number of participants affected with Other (Not Including Serious) Adverse Events represents overall number of participants with non-serious TEAEs reported with a threshold of 5% in any of the arms
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeolaryngeal pain
|
4.0%
1/25 • Treatment-emergent adverse events (TEAEs) were collected from Time 0 on Day 1 to the Follow-up Visit on Day 4, and were followed until resolution (with or without sequelae) up to a maximum of 30 days after Time 0.
Total number of participants affected with Other (Not Including Serious) Adverse Events represents overall number of participants with non-serious TEAEs reported with a threshold of 5% in any of the arms
|
4.0%
1/25 • Treatment-emergent adverse events (TEAEs) were collected from Time 0 on Day 1 to the Follow-up Visit on Day 4, and were followed until resolution (with or without sequelae) up to a maximum of 30 days after Time 0.
Total number of participants affected with Other (Not Including Serious) Adverse Events represents overall number of participants with non-serious TEAEs reported with a threshold of 5% in any of the arms
|
0.00%
0/25 • Treatment-emergent adverse events (TEAEs) were collected from Time 0 on Day 1 to the Follow-up Visit on Day 4, and were followed until resolution (with or without sequelae) up to a maximum of 30 days after Time 0.
Total number of participants affected with Other (Not Including Serious) Adverse Events represents overall number of participants with non-serious TEAEs reported with a threshold of 5% in any of the arms
|
8.0%
2/25 • Treatment-emergent adverse events (TEAEs) were collected from Time 0 on Day 1 to the Follow-up Visit on Day 4, and were followed until resolution (with or without sequelae) up to a maximum of 30 days after Time 0.
Total number of participants affected with Other (Not Including Serious) Adverse Events represents overall number of participants with non-serious TEAEs reported with a threshold of 5% in any of the arms
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At least 60 days prior to submission for publication, presentation or use, sponsor shall review and comment any proposed oral or written publication, which period may be extended for an additional 30 days. To seek patent protection, sponsor shall have the right to delay the proposed publication for an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER