Efficacy and Safety of 4.0 mg/kg Sugammadex at 1-2 PTC in Chinese and European Subjects (Study 19.4.335)(P05775AM1)(COMPLETED)

NCT00826176 | Completed Phase 3 Results

• 2 other identifiers: P0577519.4.335
• Study Type: interventional
• Target: 164
• Locations: 0 countries
• Sites: N/A

Brief Summary

The present trial is set up to evaluate the efficacy and safety of 4.0 mg.kg-1 sugammadex in Chinese and Caucasian subjects for registration purposes in China.

Conditions

Anesthesia, General; Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

• Time From Start of Administration of Sugammadex 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 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.

  Start of administration of sugammadex to recovery from neuromuscular blockade

Secondary Outcomes (2)

• Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7

  Start of administration of sugammadex to recovery from neuromuscular blockade

• Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.8

  Start of administration of sugammadex to recovery from neuromuscular blockade

Study Arms (2)

Sugammadex in Caucasian Subjects

EXPERIMENTAL

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.

Drug: Sugammadex

Sugammadex in Chinese Subjects

EXPERIMENTAL

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.

Drug: Sugammadex

Interventions

Sugammadex DRUG

After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was to be administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium intravenous (IV) could have been administered if necessary. At 1-2 PTC after the last administration of rocuronium, an IV single bolus dose of 4.0 mg/kg sugammadex was to be administered.

Also known as: Org 25969, Bridion®

Sugammadex in Caucasian Subjects; Sugammadex in Chinese Subjects

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Yu B, Wang X, Helbo Hansen HS, Huang W-Q, Askeland B, Li S, Ding Z, Abels E, Rietbergen H, Woo T, Pendeville P. Sugammadex 4.0 mg/kg reversal of deep rocuronium-induced neuromuscular blockade: a multicenter study in Chinese and Caucasian patients. J Anesthe Clin Res. 2014;5:408. doi: 10.4172/2155-6148.1000408

  RESULT

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2009
• First Posted: January 21, 2009
• Study Start: January 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: October 7, 2015
• Results First Posted: September 16, 2011

Record last verified: 2015-10