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| ID | Type | Description | Link |
|---|---|---|---|
| 19.4.324 |
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The present trial was set up to evaluate the efficacy and safety of 2.0 mg.kg-1 sugammadex compared to neostigmine administered at reappearance of T2 in Chinese and Caucasian subjects for registration purposes in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugammadex in Caucasian Subjects | Experimental | At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered. |
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| Neostigmine in Caucasian Subjects | Active Comparator | At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered. |
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| Sugammadex in Chinese Subjects | Experimental | At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered. |
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| Neostigmine in Chinese Subjects | Active Comparator | At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex | Drug | After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium intravenous (IV) could be administered if necessary. At reappearance of T2 after the last administration of rocuronium, an IV single bolus dose of 2.0 mg/kg sugammadex was administered. |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Start of Administration of Investigational Medicinal Product (IMP) to Recovery of the T4/T1 Ratio to 0.9. | 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 was to continue until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached >= 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery. The primary analysis was the comparison between sugammadex & neostigmine among Chinese subjects; other comparisons were secondary. | start of administration of sugammadex/neostigmine to recovery from neuromuscular blockade |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7 and 0.8. | Neuromuscular functioning was monitored by applying repetitive 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. | start of administration of sugammadex/neostigmine to recovery from neuromuscular blockade |
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Inclusion Criteria:
-Subjects who are willing to provide informed consent; be between 18 and 64 years old; are American Society of Anaesthesiology (ASA) class 1-3 (extremes included); scheduled for elective surgery under general anesthesia, allowing stable neuromuscular monitoring, which requires neuromuscular blockade using rocuronium; be compliant with the dose/visit schedules, and use an accepted method of contraception (if applicable).
For China only: Subjects of Chinese descent born in China, never emigrated out of China and have a Chinese home address. For Europe only: Subjects of Caucasian descent born in Europe, never emigrated out of Europe and have a European home address.
Exclusion Criteria:
-Subjects with expected difficult intubation, neuromuscular disorders affecting neuromuscular blockade, significant renal/hepatic dysfunction, use of a tourniquet, (family) history of malignant hyperthermia, allergy to general anesthesia medications, contraindication to study drugs, breast feeding, pregnant, participation in previous or new trials, a clinically significant condition that may interfere with the trial, or membership in the (family of) study/sponsor staff.
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25187755 | Result | Wu X, Oerding H, Liu J, Vanacker B, Yao S, Dahl V, Xiong L, Claudius C, Yue Y, Huang Y, Abels E, Rietbergen H, Woo T. Rocuronium blockade reversal with sugammadex vs. neostigmine: randomized study in Chinese and Caucasian subjects. BMC Anesthesiol. 2014 Jul 12;14:53. doi: 10.1186/1471-2253-14-53. eCollection 2014. |
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308 participants were randomized
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| ID | Title | Description |
|---|---|---|
| FG000 | Sugammadex in Caucasian Subjects | At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered. |
| FG001 | Neostigmine in Caucasian Subjects | At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| neostigmine | Drug | After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV could be administered if necessary. At reappearance of T2 after the last administration of rocuronium, an IV single bolus dose of 50 µg/kg neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered. |
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| FG002 | Sugammadex in Chinese Subjects | At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered. |
| FG003 | Neostigmine in Chinese Subjects | At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sugammadex in Caucasian Subjects | At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered. |
| BG001 | Neostigmine in Caucasian Subjects | At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered. |
| BG002 | Sugammadex in Chinese Subjects | At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered. |
| BG003 | Neostigmine in Chinese Subjects | At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Time From Start of Administration of Investigational Medicinal Product (IMP) to Recovery of the T4/T1 Ratio to 0.9. | 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 was to continue until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached >= 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery. The primary analysis was the comparison between sugammadex & neostigmine among Chinese subjects; other comparisons were secondary. | The Full Analysis Set (FAS) population included all subjects who received randomized treatment and had at least one efficacy measurement. In the event of missing data, imputed data were used for analysis. 291 subjects received IMP, of whom two had no efficacy measurements at all. Hence the FAS consisted of 289 subjects. | Posted | Geometric Mean | 95% Confidence Interval | minutes | start of administration of sugammadex/neostigmine to recovery from neuromuscular blockade |
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| Secondary | Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7 and 0.8. | Neuromuscular functioning was monitored by applying repetitive 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. | The Full Analysis Set population included all subjects who received randomized treatment and had at least one efficacy measurement. In the event of missing data, imputed data were used for analysis. | Posted | Geometric Mean | 95% Confidence Interval | minutes | start of administration of sugammadex/neostigmine to recovery from neuromuscular blockade |
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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 | Sugammadex in Caucasian Subjects | At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered. | 0 | 29 | 18 | 29 | ||
| EG001 | Neostigmine in Caucasian Subjects | At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered. | 2 | 31 | 26 | 31 | ||
| EG002 | Sugammadex in Chinese Subjects | At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered. | 0 | 120 | 73 | 120 | ||
| EG003 | Neostigmine in Chinese Subjects | At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered. | 1 | 111 | 84 | 111 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Enterococcal bacteraemia | Infections and infestations | MedDRA 13.1 |
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| Anastomotic leak | Injury, poisoning and procedural complications | MedDRA 13.1 |
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| Incision site haemorrhage | Injury, poisoning and procedural complications | MedDRA 13.1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 |
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| Nausea | Gastrointestinal disorders | MedDRA 13.1 |
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| Vomiting | Gastrointestinal disorders | MedDRA 13.1 |
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| Fatigue | General disorders | MedDRA 13.1 |
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| Pyrexia | General disorders | MedDRA 13.1 |
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| Sensation of foreign body | General disorders | MedDRA 13.1 |
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| Anaesthetic complication cardiac | Injury, poisoning and procedural complications | MedDRA 13.1 |
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| Incision site pain | Injury, poisoning and procedural complications | MedDRA 13.1 |
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| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 13.1 |
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| Procedural nausea | Injury, poisoning and procedural complications | MedDRA 13.1 |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 13.1 |
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| Procedural vomiting | Injury, poisoning and procedural complications | MedDRA 13.1 |
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| Wound complication | Injury, poisoning and procedural complications | MedDRA 13.1 |
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| Dizziness | Nervous system disorders | MedDRA 13.1 |
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| Headache | Nervous system disorders | MedDRA 13.1 |
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| Insomnia | Psychiatric disorders | MedDRA 13.1 |
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| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 13.1 |
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| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 |
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| Hypotensive anaesthesia procedure | Surgical and medical procedures | MedDRA 13.1 |
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The PI must not publish/publicly present any interim results without prior written consent of sponsor. The PI must provide copies of material for sponsor to review, 45 days prior to submission for publication/presentation. The sponsor may review/comment. If the parties disagree on the appropriateness of the data analysis and presentation, the PI must agree to meet prior to submission for publication/presentation to make good faith efforts to discuss and resolve any issues or disagreement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D009388 | Neostigmine |
| D001285 | Atropine |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
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| Male |
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| A key secondary analysis was the comparison of the two treatments among Caucasian subjects. | ANOVA | ANOVA, adjusted for center effects, on log transformed times from start of administration of IMP to recovery of the T4/T1 ratio to 0.9. | ratio of geometric mean time to recovery | 4.8 | 97.5 | 3.7 | 6.0 | Ratio of time to recovery of 0.9 T4/T1 ratio (neostigmine time / sugammadex time). | No | Superiority or Other |
| A key secondary analysis was the comparison for equivalence between Chinese subjects and Caucasian subjects. | median difference (seconds) | 7 | 97.5 | -5 | 21 | Estimated median difference (Chinese - Caucasian) in seconds for the time to recovery of the T4/T1 ratio to 0.9 (after sugammadex). | Yes | Non-Inferiority or Equivalence | Equivalence was considered if the 97.5% confidence interval (CI) for median difference in recovery time (T4/T1 ratio to 0.9) was within the pre-specified range of -60 to +60 seconds. |
| OG003 | Neostigmine in Chinese Subjects | At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered. |
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