Text Size

Dose-Finding Trial With Sugammadex at 3 and 15 Minutes After 1.0 and 1.2 mg/kg Rocuronium Bromide in Subjects of ASA Class 1-3 (19.4.206)(P05944)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00535743
First received: September 25, 2007
Last updated: October 2, 2009
Last verified: October 2009
History of Changes
  Purpose

The objective of the trial was to explore the dose-response relation of Org 25969 given as a reversal agent at 3 and 15 minutes following administration of 1.0 and 1.2 mg/kg of Esmeron® (rocuronium) in subjects of ASA 1 to 3, and to evaluate the safety of single doses of Org 25969 administered to subjects of ASA 1 to 3.


Condition Intervention Phase
Anesthesia, General
 Drug: sugammadex (Org 25969)
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Safety Assessor-Blinded, Placebo- Controlled, Phase II, Parallel Dose-Finding Trial in Subjects of ASA 1-3 to Assess the Efficacy and Safety of 5 Doses of Sugammadex Administered at 3 and 15 Minutes After Administration of 1.0 and 1.2 mg/kg Rocuronium Bromide

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Time from start of administration of Org 25969 / placebo to recovery of the T4/T1 ratio to 0.9 [ Time Frame: After surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time from start of administration of Org 25969 / placebo to recovery of the T4/T1 ratio to 0.7; Time from start of administration of Org 25969 / placebo to recovery of the T4/T1 ratio to 0.8. [ Time Frame: After surgery ] [ Designated as safety issue: No ]

Enrollment: 174
Study Start Date: February 2004
Study Completion Date: February 2006
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
5 mL NaCl 0.9%
Other Name: NaCl 0.9%
Experimental: Sugammadex
5 different doses of Sugammadex (2 ,4, 8, 12 and 16 mg/kg)
 Drug: sugammadex (Org 25969)
Sugammadex (2, 4, 8, 12 and 16 mg/kg) was given as a reversal agent at 3 and 15 minutes following administration of 1.0 and 1.2 mg/kg of Esmeron®, respectively
Other Name: Org 25969

Detailed Description:

In the US the highest dose recommended in the package insert of Zemuron® (i.e. the trade name for Esmeron® in the US) is 1.2 mg/kg whereas in Europe it is 1.0 mg/kg. For both doses, dose recommendations for reversal with Org 25969 were to be found. Hence, the present trial was set up to explore the dose-response relation of Org 25969 given as a reversal agent at 3 and 15 minutes following administration of 1.0 and 1.2 mg/kg of Esmeron® in subjects of ASA 1 to 3. The sub-investigator who performed any subjective safety assessments after anesthesia was to be remained blinded.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects of ASA class 1 - 3, above or equal to the age of 18 years;
  • Subjects scheduled for surgical procedures with an anticipated duration of anesthesia of at least 120 minutes, without further need for muscle relaxation other than for intubation;
  • Subjects scheduled for surgical procedures in supine position;
  • Subjects who had given written informed consent.

Exclusion Criteria:

  • Subjects in whom a difficult intubation because of anatomical malformations was expected;
  • Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blocking and/or significant renal dysfunction;
  • Subjects known or suspected to have a (family) history of malignant hyperthermia;
  • Subjects known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
  • Subjects receiving medication known to interfere with neuromuscular blocking agents, such as anticonvulsants and Mg2+;
  • Subjects who had already participated in CT 19.4.206;
  • Subjects who had participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into CT 19.4.206;
  • Female subjects who were pregnant: in females pregnancy was to be excluded both from medical history and by an hCG test within 24 hours before surgery except in females who were not of childbearing potential, i.e. at least 2 years menopausal or who had undergone tubal ligation or an hysterectomy;
  • Female subjects of childbearing potential not using any of the following methods of birth control (for one month): condom or diaphragm with spermicide, vasectomized partner (>6 months), IUD, abstinence;
  • Female subjects who were breast-feeding.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by Schering-Plough

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00535743     History of Changes
Other Study ID Numbers: 19.4.206
Study First Received: September 25, 2007
Last Updated: October 2, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Rocuronium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013