AnesthesiaPhase 3NCT00988520

Study of Efficacy, Pharmacokinetics and Safety of Continuous Intravenous Infusion of Org 9426 (Study P05977)

A Phase 3 study testing Rocuronium bromide, Sevoflurane and Propofol in people with Anesthesia, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to compare the infusion rate of Org 9426 following intubating dose of Org 9426 0.6 mg/kg or 0.9 mg/kg in adult surgical patients. Read more about this study

Who is it for?: Ages 20 to 64 years
Conditions the study is for: Anesthesia
What is being tested?: Rocuronium bromide, Sevoflurane and Propofol
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: No sites listed yet
Study dates: May 2003to Sep 2003
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Subjects at least 20 but under 65 years of age.
Subjects of asa class 1, 2 or 3 for general elective surgery.
Subjects who are not considered to be pregnant.
Subjects scheduled for elective surgery under sevoflurane or propofol anesthesia, with anticipated duration of surgery of 2-5 hours.
Subjects with normal laboratory values for serum electrolytes (Na+, K+, Cl-), BUN, creatinine, total bilirubin, ALP, ALAT and ASAT as judged by the investigator or the sub-investigator.
Subjects who received an explanation of the trial and agreed informed consent in writing to participate in the trial in advance.

Who cannot join

Subjects with renal dysfunction as a complication or in the history.
Subjects with serum creatinine level greater than 1.6 mg/dL.
Subjects with severe hepatic dysfunction as a complication or in the history.
Subjects with known significant metabolic or neuromuscular disorders.
Subjects with showing dyspnea, airway obstruction or bronchial asthma.
Subjects with a history of hypersensitivity to pancuronium bromide, vecuronium bromide or bromine.

Show all 13Show fewer

Subjects with atopic diseases.
Subjects who have developed any systemic allergic symptoms related to drugs or general anesthesia.
Subjects receiving antihistamines and antiallergic agents for 1 month or more.
Subjects receiving any of the following drugs known to affect on the action of neuromuscular blocking agents on surgery day: calcium antagonists; anticonvulsants; aminoglycoside antibiotics; polypeptide antibiotics; or metronidazole.
Subjects under hypothermic anesthesia.
Subjects who participated as research subjects in another trial within the last 6 months or is now participating in other trials.
Other subjects judged to be ineligible as subjects in this trial by the discretion of the investigator or sub-investigator.

About this study

Official title: Study of Efficacy, Pharmacokinetics and Safety of Continuous Intravenous Infusion of Org 9426 Following a Single Intubating Dose in Adult Patients Undergoing Operation Under Sevoflurane or Propofol Anesthesia.

The purpose of this study is to compare the infusion rate of Org 9426 following intubating dose of Org 9426 0.6 mg/kg or 0.9 mg/kg in adult surgical patients.

Conditions: Anesthesia
Being tested: Rocuronium bromide, Sevoflurane, Propofol
Keywords: Neuromuscular Blocking Agents

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rocuronium bromideDrug
Also called SCH 900085
Continuous intravenous infusion initiated at 7 μg/kg/min and adjusted to maintain muscle relaxation
Rocuronium bromideDrug
Also called SCH 900085
Intubation dose of 0.6 mg/kg injection
Rocuronium bromideDrug
Also called SCH 900085
Intubation dose of 0.9 mg/kg injection
SevofluraneDrug
Also called Sevofrane
0.5-2.0% intravenous maintenance anesthesia
PropofolDrug
Also called Diprivan
4010 mg/kg/hr intravenous maintenance anesthesia

Study groups in NCT00988520
Study group	Role	What they receive
0.6 mg/kg intubation dose under sevoflurane	Experimental	Not described Receives: Drug: Rocuronium bromide; Drug: Sevoflurane
0.9 mg/kg intubation dose under sevoflurane	Experimental	Not described Receives: Drug: Rocuronium bromide; Drug: Sevoflurane
continuous dose following 0.6 mg/kg intubation dose + propofol	Experimental	Not described Receives: Drug: Rocuronium bromide; Drug: Propofol
continuous dose following 0.9 mg/kg intubation dose + propofol	Experimental	Not described Receives: Drug: Rocuronium bromide; Drug: Propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

Infusion rate following intubation doses of 0.6 mg/kg or 0.9 mg/kg
Measured: 90 minutes after start of continuous infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2003Sep 2003

First posted2 Oct 2009 (estimated)
Study startMay 2003
Primary completionSep 2003
Study completionSep 2003

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AnesthesiaStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00988520
Sponsor's protocol ID: P05977
Other IDs: 71103
Status last verified: May 2015
First submitted: 1 Oct 2009
Last updated: 12 May 2015
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of Efficacy, Pharmacokinetics and Safety of Continuous Intravenous Infusion of Org 9426 Following a Single Intubating Dose in Adult Patients Undergoing Operation Under Sevoflurane or Propofol Anesthesia.
ClinicalTrials.gov ID: NCT00988520
Acronym / sponsor ID: P05977
Conditions: Anesthesia
Keywords: Neuromuscular Blocking Agents
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: May 2003
Primary completion: Sep 2003 (actual)
Study completion: Sep 2003 (actual)
First posted: 2 Oct 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to compare the infusion rate of Org 9426 following intubating dose of Org 9426 0.6 mg/kg or 0.9 mg/kg in adult surgical patients.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
0.6 mg/kg intubation dose under sevoflurane	Experimental	Drug: Rocuronium bromide, Drug: Sevoflurane
0.9 mg/kg intubation dose under sevoflurane	Experimental	Drug: Rocuronium bromide, Drug: Sevoflurane
continuous dose following 0.6 mg/kg intubation dose + propofol	Experimental	Drug: Rocuronium bromide, Drug: Propofol
continuous dose following 0.9 mg/kg intubation dose + propofol	Experimental	Drug: Rocuronium bromide, Drug: Propofol

Who may qualify

Ages: 20 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Subjects at least 20 but under 65 years of age.
Subjects of asa class 1, 2 or 3 for general elective surgery.
Subjects who are not considered to be pregnant.
Subjects scheduled for elective surgery under sevoflurane or propofol anesthesia, with anticipated duration of surgery of 2-5 hours.
Subjects with normal laboratory values for serum electrolytes (Na+, K+, Cl-), BUN, creatinine, total bilirubin, ALP, ALAT and ASAT as judged by the investigator or the sub-investigator.

Key exclusion criteria (13 listed)

Subjects with renal dysfunction as a complication or in the history.
Subjects with serum creatinine level greater than 1.6 mg/dL.
Subjects with severe hepatic dysfunction as a complication or in the history.
Subjects with known significant metabolic or neuromuscular disorders.
Subjects with showing dyspnea, airway obstruction or bronchial asthma.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Rocuronium bromideAlso: SCH 900085Continuous intravenous infusion initiated at 7 μg/kg/min and adjusted to maintain muscle relaxation	Drug	0.6 mg/kg intubation dose under sevoflurane, 0.9 mg/kg intubation dose under sevoflurane, continuous dose following 0.6 mg/kg intubation dose + propofol, continuous dose following 0.9 mg/kg intubation dose + propofol
Rocuronium bromideAlso: SCH 900085Intubation dose of 0.6 mg/kg injection	Drug	0.6 mg/kg intubation dose under sevoflurane, continuous dose following 0.6 mg/kg intubation dose + propofol
Rocuronium bromideAlso: SCH 900085Intubation dose of 0.9 mg/kg injection	Drug	0.9 mg/kg intubation dose under sevoflurane, continuous dose following 0.9 mg/kg intubation dose + propofol
SevofluraneAlso: Sevofrane0.5-2.0% intravenous maintenance anesthesia	Drug	0.6 mg/kg intubation dose under sevoflurane, 0.9 mg/kg intubation dose under sevoflurane
PropofolAlso: Diprivan4010 mg/kg/hr intravenous maintenance anesthesia	Drug	continuous dose following 0.6 mg/kg intubation dose + propofol, continuous dose following 0.9 mg/kg intubation dose + propofol

Primary outcome

Infusion rate following intubation doses of 0.6 mg/kg or 0.9 mg/kg
Time frame: 90 minutes after start of continuous infusion

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.

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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rocuronium bromide, Sevoflurane and Propofol in people with Anesthesia, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infusion rate following intubation doses of 0.6 mg/kg or 0.9 mg/kg (time frame: 90 minutes after start of continuous infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00988520.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015.