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

Purpose

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

ChemIDplus related topics:

Rocuronium ORG 9426 Sugammadex Vecuronium bromide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), 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 B: Caucasian Subjects.

Further study details as provided by Organon:

Primary Outcome Measures:

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

Enrollment:	100
Study Start Date:	October 2005
Study Completion Date:	September 2006
Primary Completion Date:	September 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 Rocuronium or 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;
Caucasian subjects;
Subjects scheduled for elective surgery requiring muscle relaxation in supine position and under sevoflurane anesthesia 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 19.4.209B, or in another trial with Org 25969;
Subjects who had participated in another clinical trial, not preapproved by Organon, within 6 months of entering into CT 19.4.209B.

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers:	19.4.209B
First Received:	October 31, 2007
Last Updated:	August 15, 2008
ClinicalTrials.gov Identifier:	NCT00552929
Health Authority:	Belgium: Directoraat-Generaal Geneesmiddelen

Study placed in the following topic categories:

Signs and Symptoms

Ataxia-Telangiectasia

Rocuronium

Ataxia Telangiectasia

Vecuronium Bromide

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00552929