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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00482599
First received: June 4, 2007
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Anesthesia, General
Drug: Sugammadex
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Parallel Group, Comparative Trial Evaluating the Efficacy, Pharmacokinetics and Safety of Org 25969 in Subjects With Normal or Impaired Renal Function

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.9 [ Time Frame: After surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.7 and 0.8 [ Time Frame: After surgery ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: May 2005
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Normal renal function
Org 25969 given to subjects with normal renal function
Drug: 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
Other Name: Org 25969
Experimental: Impaired renal function
Org 25969 given to subjects with impaired renal function
Drug: 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
Other Name: Org 25969

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00482599     History of Changes
Other Study ID Numbers: P05948, 19.4.304
Study First Received: June 4, 2007
Last Updated: May 7, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 30, 2014