None listed
Conditions
Interventions
Product Name: sugammadex
Product Code: Org 25969
Pharmaceutical Form: Solution for injection
INN or Proposed INN: sugammadex
CAS Number:
Sponsors
NV Organon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • At least 18 years of age • ASA class 1-3 • Creatinine clearance (CLcr) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant hepatic dysfunction • Subjects scheduled for renal transplant surgery • 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 in a dose and/or at a time point known to interfere with NMBAs, such as antibiotics, anticonvulsants and Mg2+ • Subjects who have already participated in a sugammadex trial • Subjects who have participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into 19.4.328 • Female subjects who are pregnant* • Female subjects who are breast-feeding * In female subjects pregnancy will be excluded both from medical history and by an hCG test within 24 hours before surgery except in females who are not of childbearing potential, i.e. at least 2 years menopausal or have undergone tubal ligation or an hysterectomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To show equivalence with respect to the efficacy of sugammadex in subjects with normal or severely impaired renal function; Secondary Objective: • To evaluate the safety of sugammadex in subjects with normal or severely impaired renal function • To compare the pharmacokinetics of sugammadex in subjects with normal or severely impaired renal function ;Primary end point(s): The time from start of administration of sugammadex to recovery of the T4/T1 ratio to 0.9. | — |
Countries
Austria, France, Netherlands, United Kingdom
Outcome results
None listed