Comparison of Org 25969 With Neostigmine as Reversal Agents for Rocuronium or Vecuronium at Reappearance of T2 (19.4.301)(P05960)(COMPLETED)
This study has been completed.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00451217
First received: March 22, 2007
Last updated: October 2, 2009
Last verified: October 2009
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Purpose
The purpose of this study was to demonstrate in adult patients faster recovery from a neuromuscular block induced by either rocuronium or vecuronium after reversal at reappearance of T2 by 2.0 mg/kg Org 25969 (sugammadex) compared to 50 ug/kg neostigmine.
| Condition | Intervention | Phase |
|---|---|---|
|
Anesthesia, General |
Drug: Sugammadex Drug: neostigmine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi -Center Randomized Parallel Group Comparative Active Controlled Safety Assessor Blinded Phase 3a Pivotal Trial in Adult Subjects Comparing Org 25969 With Neostigmine as Reversal Agents of a Neuromuscular Block Induced by Rocuronium or Vecuronium at Reappearance of T2 |
Resource links provided by NLM:
Drug Information available for:
Neostigmine methylsulfate
Glycopyrrolate
Vecuronium bromide
Vecuronium
Rocuronium bromide
Rocuronium
U.S. FDA Resources
Further study details as provided by Schering-Plough:
Primary Outcome Measures:
- Time from start administration of Org 25969/neostigmine to recovery T4/T1 ratio to 0.9. [ Time Frame: After surgery ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time from start administration of Org 25969/neostigmine to recovery T4/T1 ratio to 0.7 and 0.8; assessment of clinical signs of recovery (level of consciousness, 5 sec head lift, general muscle weakness) [ Time Frame: After surgery ] [ Designated as safety issue: No ]
| Enrollment: | 198 |
| Study Start Date: | October 2005 |
| Study Completion Date: | March 2006 |
| Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Sugammadex |
Drug: Sugammadex
After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 2.0 mg/kg Org25969 was to be administered
Other Name: Org 25969
|
| Active Comparator: neostigmine |
Drug: neostigmine
After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was to be administered
Other Name: premix neostigmine/glycopyrrolate
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects of ASA 1 - 4;
- Subjects above or equal to the age of 18;
- Scheduled for surgical procedures with a general anesthesia with the use of rocuronium or vecuronium for endotracheal intubation and maintenance of neuromuscular block;
- Scheduled for surgical procedure in supine position;
- 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 block (NMB) 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 in a dose and/or at a time point known to interfere with neuromuscular blocking agents such as antibiotics, anticonvulsants and Mg2+;
- Subjects in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
- Subjects who had already participated in an Org 25969 trial;
- Subjects who had participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into CT 19.4.301.
- Female subjects who are pregnant:
- Female subjects of childbearing potential not using any method of birth control: condom or using only hormonal contraception as birth control;
- 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: | NCT00451217 History of Changes |
| Other Study ID Numbers: | 19.4.301, Aurora Trial |
| Study First Received: | March 22, 2007 |
| Last Updated: | October 2, 2009 |
| Health Authority: | Austria: Ethikkommission |
Additional relevant MeSH terms:
|
Glycopyrrolate Neostigmine Vecuronium Bromide Rocuronium Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cholinesterase Inhibitors Enzyme Inhibitors Parasympathomimetics Autonomic Agents Peripheral Nervous System Agents Neuromuscular Nondepolarizing Agents Neuromuscular Blocking Agents Neuromuscular Agents Nicotinic Antagonists |
ClinicalTrials.gov processed this record on May 23, 2013