Phase 2
Completed N=50
Efficacy and Safety of Org 25969 Administered After Zemuron® (MK-8616-042)
Neuromuscular Blockade
Source: ClinicalTrials.gov NCT03519867 ↗
Enrolled (actual)
50
Serious AEs
9.3%
Results posted
Jan 2019
Primary outcomePrimary: Time From Start of Administration of MK-8616 to Recovery T4/T1 Ratio to 0.9 — 44.18; 19.08; 5.38; 3.32 Minutes
Summary
The primary objective of this study is to explore the dose-response relation of MK-8616 (Org 25969) given as a reversal agent of Zemuron® at 1 to 2 post tetanic counts (PTCs); both Zemuron® and MK-8616 are administered by intravenous (iv) infusion. Another goal of the study is to evaluate the safety of single doses of MK-8616 administered to participants of American Society of Anesthesiologists (ASA) Physical Status Class 1 (otherwise normal, healthy participant); Class 2 (participant with a mild systemic disease); or Class 3 (participant with a severe systemic disease that limits activity, but is not incapacitating).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Start of Administration of MK-8616 to Recovery T4/T1 Ratio to 0.9 |
44.18; 19.08; 5.38; 3.32; 1.53; 20.57 | — |
| SECONDARY Percentage of Participants Experiencing ≥1 Adverse Events (AEs) |
100.0; 100.0; 60.0; 66.7; 80.0; 100.0 | — |
Eligibility Criteria
Inclusion Criteria
- Has an ASA Class of 1 to 3
- Is scheduled for surgical procedures (excluding dental and neck surgeries) with an anticipated duration of anesthesia of ≥45 minutes with the use of Zemuron®
Exclusion Criteria
- Is undergoing dental or neck surgery
- Has anatomical malformation that would impede intubation
- Has or is suspected to have neuromuscular disorders impairing neuromuscular block and/or significant renal dysfunction
- Is known or suspected to have a family history of malignant hyperthermia
- Is known or suspected to have an allergy to narcotics, muscle relaxants, or other medications used during general anesthesia
- Is pregnant
- Is a female of childbearing potential not using 1 of the following methods of birth control: condom or diaphragm with spermicide, vasectomized partner (<6 months), intrauterine device (IUD), or abstinence
- Is breast-feeding
- Has already participated in the study
- Has participated in another clinical trial, not pre-approved by Organon Pharmaceuticals USA within 30 days of entering this study
Data sourced from ClinicalTrials.gov (NCT03519867). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.