A Bridging Trial Comparing Org 25969 at Reappearance of T2 in Japanese and Caucasian Subjects. Part A: Japanese Subjects (19.4.208A)(P05956)(COMPLETED)

Condition(s) targeted: Anesthesia, General

Intervention: sugammadex (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

The objective of the trial was to establish the dose-response of T2 in Japanese and Caucasian Subjects. Part A: Japanese Subjects

Official title: A Multi-Center, Randomized, Open-Label, Prospective Bridging, Parallel Dose-Finding Trial Comparing Efficacy, Safety and Pharmacokinetics of 4 Doses of Org 25969 and Placebo Administered at Reappearance of T2 After Rocuronium or Vecuronium in Japanese and Caucasian Subjects. Part A: Japanese Subjects

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Time from start of administration of Org 25969 / placebo to recovery of the T4/T1 ratio to 0.9

Secondary outcome: Time from start of administration of Org 25969 / placebo to recovery of the T4/T1 ratio to 0.7 and 0.8

Detailed description: For most surgical procedures a depth of neuromuscular block of 1-2 twitches after TOF-stimulation is sufficient to avoid unwanted muscular activity. At reappearance of T2, the anesthesiologist might decide to either give (another) maintenance dose of rocuronium or vecuronium when surgery continues, to await spontaneous recovery of neuromuscular block or to reverse the neuromuscular block. Org 25969 has been shown in previous trials to greatly reduce the time to full recovery when administered at reappearance of T2, both after rocuronium- and vecuronium-induced neuromuscular blockade. The current trial 19. 4.208A was conducted in Japan and set up to establish the dose-response relationship of Org 25969 given during sevoflurane anesthesia at reappearance of T2 after rocuronium or vecuronium in Japanese subjects. In addition to recovery time, also pharmacokinetics and safety of Org 25969 were to be evaluated.

Minimum age: 20 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects of ASA class 1 - 3;

- Subjects at least 20 years but under 65 years of age;

- Japanese subjects;

- Subjects scheduled for elective surgery in supine position and under sevoflurane

anesthesia, in need of administration of NMBAs, with an anticipated duration of about 1. 5-3 hours;

- Subjects who had given written informed consent.

Exclusion Criteria:

- Subjects in whom a difficult intubation because of anatomical malformations was

expected;

- Subjects known or suspected to have neuromuscular disorders impairing the effect of

NMBAs and/or significant renal dysfunction (for example a creatinine level > 1. 6 mg/dl) and/or severe hepatic dysfunction.

- Subjects known or suspected to have a (family) history of malignant hyperthermia;

- Subjects known or suspected to have an allergy to narcotics, muscle relaxants or

other medication used during general anesthesia;

- Subjects receiving medication expected to interfere with the rocuronium or vecuronium

given in this trial, based on the dose and time of administration;

- Female subjects who were pregnant;

- Female subjects not using birth control or using only oral contraception as birth

control continuously;

- Subjects who were breast-feeding;

- Subjects who had already participated in CT 19. 4.208A, or in another trial with Org

25969;

- Subjects who had participated in another clinical trial within 6 months of entering

into CT 19. 4.208A.

Related publications:

Takeda J, Iwasaki H, Yamakage M, Ozaki M, Kawamata M, Hatano Y, Yorozuya T, Miyakawa H, Kanmura Y. [Efficacy and safety of sugammadex (Org 25969) in reversing moderate neuromuscular block induced by rocuronium or vecuronium in Japanese patients]. Masui. 2014 Oct;63(10):1075-82. Japanese.

Starting date: January 2006
Last updated: August 4, 2015