A multi-center, randomized, parallel dose-finding, safety-assessor blinded trial to explore the efficacy, safety and pharmacokinetics of four doses of Org 25969 and placebo in pediatric and adult subjects.

Phase 1

• Conditions: not applicable

• Registration Number: EUCTR2004-003819-23-DE
• Lead Sponsor: V Organon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-02-02
• Study Completion: 2006-06-02
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

• ASA class 1 – 2, between the ages of 28 days and 65 years inclusive, and between the ages of 2 and 65 years inclusive for Germany and between the ages of 6 and 65 years inclusive for Finland
• Scheduled for general anesthesia with an anticipated duration of anesthesia of at least 60 minutes, 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
• Subjects who, and/or whose parent(s) or legal guardian(s) have given written informed consent [or appropriate assent, if applicable]
Are the trial subjects under 18? yes
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Known or suspected neuromuscular disorders impairing NMB and/or significant renal dysfunction, in Germany creatinine and blood urea nitrogen outside local reference ranges
• Known or suspected to have a (family) history of malignant hyperthermia
• Known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia
• Use of medication expected to interfere with the rocuronium given in this trial, based on the dose and the time of administration
• Pregnancy
• Childbearing potential not using any of the following methods of birth control: condom or diaphragm with spermicide, vasectomized partner ( > 6 months), IUD, 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 19.4.306

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • To explore the dose-response relation of Org 25969 given as a reversal agent at reappearance of T2 after 0.6 mg.kg-1 rocuronium in pediatric and adult subjects;<br> Secondary Objective: • To explore the pharmacokinetics of Org 25969 in pediatric and adult subjects<br> • To evaluate the safety of Org 25969 in pediatric and adult subjects<br> ;Primary end point(s): Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.9