Efficacy, Pharmacokinetics and Safety of Org 25969 in Subjects With Normal or Impaired Renal Function (19.4.304)(P05948)(COMPLETED)
Primary Purpose
Anesthesia, General
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Sugammadex
Sponsored by
About this trial
This is an interventional treatment trial for Anesthesia, General
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Normal renal function
Impaired renal function
Arm Description
Org 25969 given to subjects with normal renal function
Org 25969 given to subjects with impaired renal function
Outcomes
Primary Outcome Measures
Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.9
Secondary Outcome Measures
Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.7 and 0.8
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00482599
Brief Title
Efficacy, Pharmacokinetics and Safety of Org 25969 in Subjects With Normal or Impaired Renal Function (19.4.304)(P05948)(COMPLETED)
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
June 1, 2005 (Actual)
Primary Completion Date
April 13, 2006 (Actual)
Study Completion Date
April 13, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, General
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal renal function
Arm Type
Active Comparator
Arm Description
Org 25969 given to subjects with normal renal function
Arm Title
Impaired renal function
Arm Type
Experimental
Arm Description
Org 25969 given to subjects with impaired renal function
Intervention Type
Drug
Intervention Name(s)
Sugammadex
Other Intervention Name(s)
Org 25969
Intervention Description
2 mg/kg sugammadex administered intravenously at reappearance of T2 after 0.6 mg/kg rocuronium in patients with renal impairment and control patients
Primary Outcome Measure Information:
Title
Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.9
Time Frame
After surgery
Secondary Outcome Measure Information:
Title
Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.7 and 0.8
Time Frame
After surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
20007792
Citation
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.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
Efficacy, Pharmacokinetics and Safety of Org 25969 in Subjects With Normal or Impaired Renal Function (19.4.304)(P05948)(COMPLETED)
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