Efficacy and Safety of Org 25969 Administered After Zemuron® (MK-8616-042)

Neuromuscular Blockade Clinical Trial

Official title:

A Multi-center, Randomized, Assessor-blinded, Phase II, Parallel Dose-finding Trial in Subjects of ASA Class 1 - 3 to Assess the Efficacy and Safety of 5 Doses of Org 25969 When Administered at 1-2 PTCs After Administration of Zemuron®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03519867
• Other study ID #: P06387
• Secondary ID: MK-8616-04219.4.
• Status: Completed
• Phase: Phase 2
• Start date: August 1, 2004
• Est. completion date: May 26, 2005

Study information

• Verified date: August 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 26, 2005
• Est. primary completion date: May 26, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Drug:
• MK-8616
MK-8616 will be administered at doses of 0.5, 1.0, 2.0, 4.0 and 8.0 mg/kg iv as a 30-second infusion. Doses are based on actual body weight.
• Zemuron®
Zemuron® (0.6 or 1.2 mg/kg, iv) will be administered as a 10-second bolus infusion to achieve 1 to 2 PTCs. If needed, a maintenance dose of 0.15 mg/kg will be given. Doses are based on actual body weight.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time From Start of Administration of MK-8616 to Recovery T4/T1 Ratio to 0.9	The mean time from the start of MK-8616 administration to recovery T4/T1 ratio of 0.9 was determined. Less time indicates faster recovery from NMB. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four [TOF] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX.	Up to 90 minutes
Secondary	Percentage of Participants Experiencing =1 Adverse Events (AEs)	The percentage of participants experiencing =1 AEs was determined. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment.	Up to 7 days following MK-8616 administration