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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005050-47-GB

Enrollment

Registered

2005-12-02

Start date

2006-01-24

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Product Name: Org 25969 Product Code: Org 25969 Pharmaceutical Form: Solution for injection INN or Proposed INN: sugammadex CAS Number:

Eligibility

Sex/Gender

All

Inclusion 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) =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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), 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

Design outcomes

Primary

Measure	Time frame
Main Objective: • To show equivalence with respect to the efficacy of Org 25969 in subjects with normal or impaired renal function • To compare the pharmacokinetics of Org 25969 in subjects with normal or impaired renal function • To evaluate the safety of Org 25969 in subjects with impaired renal function ;Secondary Objective: ;Primary end point(s): Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.9.	—

Measure

Time frame

Main Objective: • To show equivalence with respect to the efficacy of Org 25969 in subjects with normal or impaired renal function • To compare the pharmacokinetics of Org 25969 in subjects with normal or impaired renal function • To evaluate the safety of Org 25969 in subjects with impaired renal function ;Secondary Objective: ;Primary end point(s): Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.9.

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Countries

Germany, United Kingdom

Outcome results