Muscle RelaxationPhase 3NCT00984633
Study of Efficacy, Pharmacokinetics, and Safety of Bolus Maintenance Doses of Org 9426 (Study P05976)(COMPLETED)
A Phase 3 study testing Rocuronium bromide (Org 9426), Sevoflurane and Propofol in people with Muscle Relaxation, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to evaluate the efficacy, pharmacokinetics, and safety of Org 9426 in maintenance of muscle relaxation in adult subjects undergoing general elective surgery. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Muscle Relaxation
- What is being tested?
- Rocuronium bromide (Org 9426), Sevoflurane and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2003to Dec 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 about 1.5-3 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.
- 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 the sub-investigator.
About this study
Official title: Study of Efficacy, Pharmacokinetics, and Safety of Bolus Maintenance Doses of Org 9426 Following a Single Intubating Dose in Adult Subjects Undergoing Operation Under Sevoflurane or Propofol Anesthesia
The purpose of this study is to evaluate the efficacy, pharmacokinetics, and safety of Org 9426 in maintenance of muscle relaxation in adult subjects undergoing general elective surgery.
- Conditions
- Muscle Relaxation
- Being tested
- Rocuronium bromide (Org 9426), 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 bromide (Org 9426)Drug
Also called SCH 900085
0.6 mg/kg injection intubation dose
Rocuronium bromide (Org 9426)Drug
Also called SCH 900085
0.9 mg/kg injection intubation dose
SevofluraneDrug
Also called Sevofrane
0.5-2.0% intravenous maintenance anesthesia
PropofolDrug
Also called Diprivan
4-10 mg/kg/hr maintenance anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 0.6 mg/kg intubation dose + sevoflurane | Experimental | Not described Receives: Drug: Rocuronium bromide (Org 9426); Drug: Sevoflurane |
| 0.9 mg/kg intubation dose + sevoflurane | Experimental | Not described Receives: Drug: Rocuronium bromide (Org 9426); Drug: Sevoflurane |
| 0.6 mg/kg intubation dose + propofol | Experimental | Not described Receives: Drug: Rocuronium bromide (Org 9426); Drug: Propofol |
| 0.9 mg/kg intubation dose + propofol | Experimental | Not described Receives: Drug: Rocuronium bromide (Org 9426); Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical duration of 2 doses of Org 9426 in maintenance of muscle relaxation
Measured: Time from intubating dose to bolus maintenance dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startJun 2003
- Primary completionDec 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle RelaxationStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984633
- Sponsor's protocol ID
- P05976
- Other IDs
- 71102
- Status last verified
- May 2015
- First submitted
- 24 Sep 2009
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
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 Bolus Maintenance Doses of Org 9426 Following a Single Intubating Dose in Adult Subjects Undergoing Operation Under Sevoflurane or Propofol Anesthesia
- ClinicalTrials.gov ID
- NCT00984633
- Acronym / sponsor ID
- P05976
- Conditions
- Muscle Relaxation
- Keywords
- Neuromuscular Blocking Agents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 25 Sep 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 evaluate the efficacy, pharmacokinetics, and safety of Org 9426 in maintenance of muscle relaxation in adult subjects undergoing general elective surgery.
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 + sevoflurane | Experimental | Drug: Rocuronium bromide (Org 9426), Drug: Sevoflurane |
| 0.9 mg/kg intubation dose + sevoflurane | Experimental | Drug: Rocuronium bromide (Org 9426), Drug: Sevoflurane |
| 0.6 mg/kg intubation dose + propofol | Experimental | Drug: Rocuronium bromide (Org 9426), Drug: Propofol |
| 0.9 mg/kg intubation dose + propofol | Experimental | Drug: Rocuronium bromide (Org 9426), 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 about 1.5-3 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 bromide (Org 9426)Also: SCH 9000850.6 mg/kg injection intubation dose | Drug | 0.6 mg/kg intubation dose + propofol, 0.6 mg/kg intubation dose + sevoflurane |
| Rocuronium bromide (Org 9426)Also: SCH 9000850.9 mg/kg injection intubation dose | Drug | 0.9 mg/kg intubation dose + propofol, 0.9 mg/kg intubation dose + sevoflurane |
| SevofluraneAlso: Sevofrane0.5-2.0% intravenous maintenance anesthesia | Drug | 0.6 mg/kg intubation dose + sevoflurane, 0.9 mg/kg intubation dose + sevoflurane |
| PropofolAlso: Diprivan4-10 mg/kg/hr maintenance anesthesia | Drug | 0.6 mg/kg intubation dose + propofol, 0.9 mg/kg intubation dose + propofol |
Primary outcome
Clinical duration of 2 doses of Org 9426 in maintenance of muscle relaxation
Time frame: Time from intubating dose to bolus maintenance dose
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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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 (Org 9426), Sevoflurane and Propofol in people with Muscle Relaxation, 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?
Clinical duration of 2 doses of Org 9426 in maintenance of muscle relaxation (time frame: Time from intubating dose to bolus maintenance dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.