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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03519867
Recruitment Status : Completed
First Posted : May 9, 2018
Results First Posted : January 31, 2019
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE May 8, 2018
First Posted Date  ICMJE May 9, 2018
Results First Submitted Date  ICMJE August 30, 2018
Results First Posted Date  ICMJE January 31, 2019
Last Update Posted Date January 31, 2019
Actual Study Start Date  ICMJE August 1, 2004
Actual Primary Completion Date May 26, 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
Time From Start of Administration of MK-8616 to Recovery T4/T1 Ratio to 0.9 [ Time Frame: Up to 90 minutes ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 8, 2018)
Time From Start of Administration of MK-8616 to Recovery T4/T1 Ratio to 0.9 [ Time Frame: Up to 30 minutes ]
Change History Complete list of historical versions of study NCT03519867 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
Percentage of Participants Experiencing ≥1 Adverse Events (AEs) [ Time Frame: Up to 7 days following MK-8616 administration ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2018)
Number of participants experiencing an adverse event (AE) [ Time Frame: Up to 7 days following MK-8616 administration ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Org 25969 Administered After Zemuron® (MK-8616-042)
Official Title  ICMJE 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®
Brief 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neuromuscular Blockade
Intervention  ICMJE
  • 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.
    Other Name: Org 25969, sugammadex, Bridion®
  • Drug: 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.
    Other Name: Rocuronium bromide
Study Arms  ICMJE
  • Experimental: 1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg
    Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced neuromuscular blockade (NMB) reaches 1 to 2 PTCs.
    Interventions:
    • Drug: MK-8616
    • Drug: Zemuron®
  • Experimental: 2) Zemuron® 1.2 mg/kg + MK-8616 0.5 mg/kg
    Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs.
    Interventions:
    • Drug: MK-8616
    • Drug: Zemuron®
  • Experimental: 3) Zemuron® 0.6 mg/kg + MK-8616 1.0 mg/kg
    Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs.
    Interventions:
    • Drug: MK-8616
    • Drug: Zemuron®
  • Experimental: 4) Zemuron® 1.2 mg/kg + MK-8616 1.0 mg/kg
    Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs.
    Interventions:
    • Drug: MK-8616
    • Drug: Zemuron®
  • Experimental: 5) Zemuron® 0.6 mg/kg + MK-8616 2.0 mg/kg
    Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs.
    Interventions:
    • Drug: MK-8616
    • Drug: Zemuron®
  • Experimental: 6) Zemuron® 1.2 mg/kg + MK-8616 2.0 mg/kg
    Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs.
    Interventions:
    • Drug: MK-8616
    • Drug: Zemuron®
  • Experimental: 7) Zemuron® 0.6 mg/kg + MK-8616 4.0 mg/kg
    Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs.
    Interventions:
    • Drug: MK-8616
    • Drug: Zemuron®
  • Experimental: 8) Zemuron® 1.2 mg/kg + MK-8616 4.0 mg/kg
    Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs.
    Interventions:
    • Drug: MK-8616
    • Drug: Zemuron®
  • Experimental: 9) Zemuron® 0.6 mg/kg + MK-8616 8.0 mg/kg
    Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs.
    Interventions:
    • Drug: MK-8616
    • Drug: Zemuron®
  • Experimental: 10) Zemuron® 1.2 mg/kg + MK-8616 8.0 mg/kg
    Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs.
    Interventions:
    • Drug: MK-8616
    • Drug: Zemuron®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 30, 2018)
50
Original Actual Enrollment  ICMJE
 (submitted: May 8, 2018)
60
Actual Study Completion Date  ICMJE May 26, 2005
Actual Primary Completion Date May 26, 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03519867
Other Study ID Numbers  ICMJE P06387
MK-8616-042 ( Other Identifier: Merck Protocol Number )
19.4.204 ( Other Identifier: Organon Protocol Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP