Efficacy, Pharmacokinetics and Safety of Org 25969 in Subjects With Normal or Impaired Renal Function (19.4.304)(P05948)(COMPLETED)
June 15, 2017 updated by: Merck Sharp & Dohme LLC
A Multicenter, Parallel Group, Comparative Trial Evaluating the Efficacy, Pharmacokinetics and Safety of Org 25969 in Subjects With Normal or Impaired Renal Function
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Normal renal function
Org 25969 given to subjects with normal renal function
|
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 Names:
|
|
Experimental: Impaired renal function
Org 25969 given to subjects with impaired renal function
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.9
Time Frame: After surgery
|
After surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.7 and 0.8
Time Frame: After surgery
|
After surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2005
Primary Completion (Actual)
April 13, 2006
Study Completion (Actual)
April 13, 2006
Study Registration Dates
First Submitted
June 4, 2007
First Submitted That Met QC Criteria
June 4, 2007
First Posted (Estimate)
June 5, 2007
Study Record Updates
Last Update Posted (Actual)
June 16, 2017
Last Update Submitted That Met QC Criteria
June 15, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P05948
- 19.4.304
Plan for Individual participant data (IPD)
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.