A multi-center, parallel-group, comparative trial evaluating the efficacy, pharmacokinetics and safety of Org 25969 in subjects with normal or impaired renal function. - Spring
- Conditions
- ot Applicable
- Registration Number
- EUCTR2005-005050-47-GB
- Lead Sponsor
- V Organon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
• 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• 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), intra-uterine device, abstinence
• Breast-feeding
• Prior participation in any trial with Org 25969
• Participation in another clinical trial, within 30 days of entering into trial 19.4.304
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: • To show equivalence with respect to the efficacy of Org 25969 in subjects with normal or impaired renal function<br> • To compare the pharmacokinetics of Org 25969 in subjects with normal or impaired renal function<br> • To evaluate the safety of Org 25969 in subjects with impaired renal function<br> ;Secondary Objective: ;Primary end point(s): Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.9.
- Secondary Outcome Measures
Name Time Method