A Bridging Trial Comparing Org 25969 at 1-2 PTC in Japanese and Caucasian Subjects. Part A: Japanese Subjects (19.4.209A)(P05957)(COMPLETED) - Full Text View

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00591786

Purpose

The objective of the trial was to establish the dose-response relation of Org 25969 (sugammadex) given as a reversal agent of rocuronium or vecuronium at 1-2 PTC during sevoflurane anesthesia for Japanese subjects.

Condition	Intervention	Phase
Anesthesia, General	Drug: Sugammadex Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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 1-2 PTC After Rocuronium or Vecuronium in Japanese and Caucasian Subjects. Part A: Japanese Subjects.

Resource links provided by NLM:

Drug Information available for: Vecuronium bromide ORG 9426 Rocuronium Sugammadex Sugammadex Sodium

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Time from start of administration of Org 25969 to recovery of the T4/T1 ratio to 0.9 [ Time Frame: After surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time from start of administration of Org 25969 to recovery of the T4/T1 ratio to 0.7, 0.8 [ Time Frame: After surgery ] [ Designated as safety issue: No ]

Enrollment:	100
Study Start Date:	December 2005
Study Completion Date:	August 2006
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Sugammadex	Drug: Sugammadex 4 Doses of Sugammadex Administered at 1-2 PTC After 0.9 mg/kg Rocuronium or 0.1 mg/kg Vecuronium Other Name: Org 25969
Placebo Comparator: 2 Placebo	Drug: Placebo 4 Doses of placebo Administered at 1-2 PTC After 0.9 mg/kg Rocuronium or 0.1 mg/kg Vecuronium

Eligibility

Ages Eligible for Study:	20 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 NMB 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 of childbearing potential not using birth control or using only oral contraception as birth control;
Subjects who were breast-feeding;
Subjects who had already participated in CT 19.4.209A, or in another trial with Org 25969;
Subjects who had participated in another clinical trial within 6 months of entering into CT 19.4.209A.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00591786 History of Changes
Other Study ID Numbers:	19.4.209A
Study First Received:	December 27, 2007
Last Updated:	October 2, 2009
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:

Vecuronium Bromide
Rocuronium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012