Trial Outcomes & Findings for Efficacy and Safety of 4.0 mg/kg Sugammadex at 1-2 PTC in Chinese and European Subjects (Study 19.4.335)(P05775AM1)(COMPLETED) (NCT NCT00826176)
NCT ID: NCT00826176
Last Updated: 2015-10-07
Results Overview
Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery. Analysis of recovery in Chinese subjects was the primary objective; Caucasian subjects and between-group analyses were secondary.
COMPLETED
PHASE3
164 participants
Start of administration of sugammadex to recovery from neuromuscular blockade
2015-10-07
Participant Flow
Two subjects were screened but not enrolled (one Chinese subject and one Caucasian subject).
Participant milestones
| Measure |
Sugammadex in Chinese Subjects
At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
|
Sugammadex in Caucasian Subjects
At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
|
|---|---|---|
|
Overall Study
STARTED
|
128
|
36
|
|
Overall Study
COMPLETED
|
115
|
36
|
|
Overall Study
NOT COMPLETED
|
13
|
0
|
Reasons for withdrawal
| Measure |
Sugammadex in Chinese Subjects
At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
|
Sugammadex in Caucasian Subjects
At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Subject Withdrew Consent
|
3
|
0
|
|
Overall Study
Administrative
|
9
|
0
|
Baseline Characteristics
Efficacy and Safety of 4.0 mg/kg Sugammadex at 1-2 PTC in Chinese and European Subjects (Study 19.4.335)(P05775AM1)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Sugammadex in Chinese Subjects
n=115 Participants
At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
|
Sugammadex in Caucasian Subjects
n=36 Participants
At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.9 years
STANDARD_DEVIATION 10.0 • n=39 Participants
|
47.2 years
STANDARD_DEVIATION 11.0 • n=41 Participants
|
47.7 years
STANDARD_DEVIATION 10.2 • n=35 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=39 Participants
|
29 Participants
n=41 Participants
|
95 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
56 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Start of administration of sugammadex to recovery from neuromuscular blockadePopulation: The Full Analysis Set (FAS) consisted of all subjects who received sugammadex and had at least one efficacy measurement. One treated Chinese subject did not have any efficacy data and was thus excluded from the FAS. Hence, 114 Chinese Asian and 36 European Caucasian subjects were included in the FAS.
Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery. Analysis of recovery in Chinese subjects was the primary objective; Caucasian subjects and between-group analyses were secondary.
Outcome measures
| Measure |
Sugammadex in Chinese Subjects
n=114 Participants
At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
|
Sugammadex in Caucasian Subjects
n=36 Participants
At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
|
|---|---|---|
|
Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.9
|
2.3 minutes
Interval 2.1 to 2.6
|
1.4 minutes
Interval 1.3 to 1.6
|
SECONDARY outcome
Timeframe: Start of administration of sugammadex to recovery from neuromuscular blockadePopulation: The Full Analysis Set (FAS) consisted of all subjects who received sugammadex and had at least one efficacy measurement. One treated Chinese subject did not have any efficacy data and was thus excluded from the FAS. Hence, 114 Chinese Asian and 36 European Caucasian subjects were included in the FAS.
Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade.
Outcome measures
| Measure |
Sugammadex in Chinese Subjects
n=114 Participants
At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
|
Sugammadex in Caucasian Subjects
n=36 Participants
At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
|
|---|---|---|
|
Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7
|
1.6 minutes
Interval 1.5 to 1.8
|
1.1 minutes
Interval 1.0 to 1.2
|
SECONDARY outcome
Timeframe: Start of administration of sugammadex to recovery from neuromuscular blockadePopulation: The Full Analysis Set (FAS) consisted of all subjects who received sugammadex and had at least one efficacy measurement. One treated Chinese subject did not have any efficacy data and was thus excluded from the FAS. Hence, 114 Chinese Asian and 36 European Caucasian subjects were included in the FAS.
Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade.
Outcome measures
| Measure |
Sugammadex in Chinese Subjects
n=114 Participants
At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
|
Sugammadex in Caucasian Subjects
n=36 Participants
At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
|
|---|---|---|
|
Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.8
|
1.9 minutes
Interval 1.7 to 2.1
|
1.2 minutes
Interval 1.1 to 1.3
|
Adverse Events
Sugammadex in Chinese Subjects
Sugammadex in Caucasian Subjects
Serious adverse events
| Measure |
Sugammadex in Chinese Subjects
n=115 participants at risk
At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
|
Sugammadex in Caucasian Subjects
n=36 participants at risk
At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
|
|---|---|---|
|
Injury, poisoning and procedural complications
post procedural haemorrhage
|
0.00%
0/115
|
2.8%
1/36 • Number of events 1
|
Other adverse events
| Measure |
Sugammadex in Chinese Subjects
n=115 participants at risk
At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
|
Sugammadex in Caucasian Subjects
n=36 participants at risk
At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
|
|---|---|---|
|
Gastrointestinal disorders
abdominal pain
|
0.87%
1/115 • Number of events 1
|
16.7%
6/36 • Number of events 9
|
|
Gastrointestinal disorders
abdominal pain lower
|
0.00%
0/115
|
16.7%
6/36 • Number of events 10
|
|
Gastrointestinal disorders
nausea
|
7.0%
8/115 • Number of events 8
|
19.4%
7/36 • Number of events 10
|
|
Gastrointestinal disorders
vomiting
|
10.4%
12/115 • Number of events 12
|
13.9%
5/36 • Number of events 5
|
|
General disorders
instillation site erythema
|
0.00%
0/115
|
5.6%
2/36 • Number of events 2
|
|
Injury, poisoning and procedural complications
incision site pain
|
22.6%
26/115 • Number of events 26
|
2.8%
1/36 • Number of events 1
|
|
Injury, poisoning and procedural complications
procedural hypotension
|
2.6%
3/115 • Number of events 3
|
16.7%
6/36 • Number of events 10
|
|
Injury, poisoning and procedural complications
wound complication
|
0.00%
0/115
|
8.3%
3/36 • Number of events 7
|
|
Nervous system disorders
dizziness
|
2.6%
3/115 • Number of events 3
|
13.9%
5/36 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
7.8%
9/115 • Number of events 9
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
rhinalgia
|
0.00%
0/115
|
8.3%
3/36 • Number of events 3
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator may not publish/publicly present interim results without prior consent of Sponsor. Any materials that report results of the study must be sent to Sponsor 45 days prior to submission for publication/presentation. Sponsor has right to review and comment. In case of any disagreements concerning appropriateness of the materials, investigator and Sponsor must meet to make a good faith effort to discuss/resolve the issues or disagreement, prior to submission for publication/presentation.
- Publication restrictions are in place
Restriction type: OTHER