Efficacy, Pharmacokinetics and Safety of Org 25969 in Subjects With Normal or Impaired Renal Function (19.4.304)(P05948)(COMPLETED)

NCT ID: NCT00482599

Last Updated: 2017-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-01
• Study Completion Date: 2006-04-13

Brief Summary

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.

Conditions

Anesthesia, General

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Normal renal function

Org 25969 given to subjects with normal renal function

Group Type: ACTIVE_COMPARATOR

Sugammadex

Intervention Type: DRUG

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

Org 25969 given to subjects with impaired renal function

Group Type: EXPERIMENTAL

Sugammadex

Intervention Type: DRUG

2 mg/kg sugammadex administered intravenously at reappearance of T2 after 0.6 mg/kg rocuronium in patients with renal impairment and control patients

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Org 25969

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Staals LM, Snoeck MM, Driessen JJ, van Hamersvelt HW, Flockton EA, van den Heuvel MW, Hunter JM. Reduced clearance of rocuronium and sugammadex in patients with severe to end-stage renal failure: a pharmacokinetic study. Br J Anaesth. 2010 Jan;104(1):31-9. doi: 10.1093/bja/aep340.

Reference Type: DERIVED

PMID: 20007792 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

19.4.304

Identifier Type: -

Identifier Source: secondary_id

P05948

Identifier Type: -

Identifier Source: org_study_id