Efficacy, Pharmacokinetics and Safety of Org 25969 in Subjects With Normal or Impaired Renal Function (19.4.304)(COMPLETED) - Full Text View

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00482599

Purpose

The purpose of this study is to compare the efficacy and pharmacokinetics of Org 25969 in subjects with normal or impaired renal function and to evaluate the safety of Org 25969 in subjects with impaired renal function.

Condition	Intervention	Phase
Anesthesia, General	Drug: Sugammadex	Phase III

Drug Information available for: Rocuronium ORG 9426 Sugammadex

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Parallel Group, Comparative Trial Evaluating the Efficacy, Pharmacokinetics and Safety of Org 25969 in Subjects With Normal or Impaired Renal Function

Further study details as provided by Organon:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	30
Study Start Date:	May 2005
Study Completion Date:	April 2006
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Normal renal function: Active Comparator Org 25969 given to subjects with normal renal function	Drug: Sugammadex 2 mg/kg sugammadex administered intravenously at reappearance of T2 after 0.6 mg/kg rocuronium in patients with renal impairment and control patients
Impaired renal function: Experimental Org 25969 given to subjects with impaired renal function	Drug: Sugammadex 2 mg/kg sugammadex administered intravenously at reappearance of T2 after 0.6 mg/kg rocuronium in patients with renal impairment and control patients

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

ASA class 1 - 3 for renally impaired patients, ASA class 1-2 for control group
Age at least 18 years
Scheduled for general anesthesia without further need for muscle relaxation other than one single dose of 0.6 mg.kg-1 rocuronium
Scheduled for surgical procedures in the supine position
Written informed consent
Creatinine clearance (CLCR) < 30 mL/min for renally impaired group, CLCR = 80 mL/min for control group

Exclusion Criteria:

Known or suspected neuromuscular disorders impairing NMB
Known or suspected (family) history of malignant hyperthermia
Known or suspected allergy to narcotics, muscle relaxants or other medication used during general anesthesia
Use of medication known to interfere with NMBA based on the dose and the time of administration, such as antibiotics, anticonvulsants and Mg2+
Pregnancy
Childbearing potential without using any of the following methods of birth control: condom or diaphragm with spermicide, vasectomized partner ( > 6 months), intrauterine device, abstinence
Breast-feeding
Prior participation in any trial with Org 25969
Participation in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into trial 19.4.304, or for the UK only: Participation in another clinical trial, within 30 days of entering into trial 19.4.304.

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers:	19.4.304
Study First Received:	June 4, 2007
Last Updated:	August 15, 2008
ClinicalTrials.gov Identifier:	NCT00482599
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study placed in the following topic categories:

Rocuronium

ClinicalTrials.gov processed this record on January 14, 2009