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

Sponsored by:	Organon
Information provided by:	Organon
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

Genetics Home Reference related topics: ataxia-telangiectasia

MedlinePlus related topics: Anesthesia Ataxia Telangiectasia

Drug Information available for: Rocuronium ORG 9426 Sugammadex Vecuronium bromide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
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.

Further study details as provided by Organon:

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
1: Experimental Sugammadex	Drug: Sugammadex 4 Doses of Sugammadex Administered at 1-2 PTC After 0.9 mg/kg Rocuronium or 0.1 mg/kg Vecuronium
2: Placebo Comparator 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

Responsible Party:	NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers:	19.4.209A
Study First Received:	December 27, 2007
Last Updated:	August 15, 2008
ClinicalTrials.gov Identifier:	NCT00591786
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Signs and Symptoms
Ataxia-Telangiectasia
Rocuronium
Ataxia Telangiectasia
Vecuronium Bromide

ClinicalTrials.gov processed this record on January 16, 2009