AnesthesiaPhase 3NCT00124722
A Study to Compare Different Intubating Doses of Zemuron in Pediatric and Adolescent Subjects Under General Anesthesia
A Phase 3 study testing Rocuronium bromide (Zemuron) in people with Anesthesia, run by Merck Sharp & Dohme LLC.
Trial summary
The primary purpose of this study is to evaluate the time course of muscle relaxation after administration of three different single intravenous bolus doses of rocuronium bromide for intubation (insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation) in term neonates (birth to… Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Rocuronium bromide (Zemuron)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- No sites listed yet
- Study dates
- Dec 2004to Jul 2007
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female subjects from birth up to 17 years of age who will be scheduled for surgery under general anesthesia.
Who cannot join
- Subjects whose parent(s) or legal guardian(s) are not willing to give written consent and where applicable, subjects who have not given appropriate assent to participate in the trial will not be allowed to enter.
About this study
Official title: A Randomized, Assessor-blind, Dose-ranging, Phase IIIB, Multicenter Trial Comparing the Intubating Conditions and Time Course of Block of Three Different Intubating Doses (0.45 mg/kg, 0.6 mg/kg, and 1.0 mg/kg) of Zemuron® in Pediatric and Adolescent Subjects Under General Anesthesia
The primary purpose of this study is to evaluate the time course of muscle relaxation after administration of three different single intravenous bolus doses of rocuronium bromide for intubation (insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation) in term neonates (birth to <28 days old), infants (28 days to <=3 months) and toddlers (>3 months to <=2 years), children (2 years to less than or equal to 11 years of age), and adolescents (>11 years to less than or equal to 17 years of age).
Subjects in each of the age groups will be randomized to one of 3 Zemuron® doses: 0.45 mg/kg, 0.6 mg/kg, or 1.0 mg/kg.
- Conditions
- Anesthesia
- Being tested
- Rocuronium bromide (Zemuron)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocuronium bromide (Zemuron)Drug
Also called ORG 9426, SCH 900085, Zemuron
A single IV Zemuron bolus dose of 0.45 mg/kg prior to intubation.
Rocuronium bromide (Zemuron)Drug
Also called ORG 9426, SCH 900085, Zemuron
A single IV Zemuron bolus dose of 0.6 mg/kg prior to intubation.
Rocuronium bromide (Zemuron)Drug
Also called ORG 9426, SCH 900085, Zemuron
A single IV Zemuron bolus dose of 1.0 mg/kg prior to intubation.
| Study group | Role | What they receive |
|---|---|---|
| 0.45 mg/kg Zemuron | Experimental | 0.45 mg/kg Zemuron Receives: Drug: Rocuronium bromide (Zemuron) |
| 0.6 mg/kg Zemuron | Active comparator | 0.6 mg/kg Zemuron Receives: Drug: Rocuronium bromide (Zemuron) |
| 1.0 mg/kg Zemuron | Experimental | 1.0 mg/kg Zemuron Receives: Drug: Rocuronium bromide (Zemuron) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to reappearance of T3 (time from end-administration of Zemuron to reappearance of the third twitch of a TOF stimulation)
Measured: during surgery
Secondary outcomes (1)
Onset time, maximum block, time to reappearance of T1, Recovery to TOF 0.7, 0.8 and 0.9 and intubation score
Measured: during and after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2005 (estimated)
- Study startDec 2004
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 207 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
- NCT00124722
- Sponsor's protocol ID
- P05798
- Other IDs
- 021049
- Status last verified
- May 2015
- First submitted
- 26 Jul 2005
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tirotta CF, Brandom B, Siddiqui MS, Ehlers M, Betzel J, Chen J-Y, De Bie J, Blobner M. Time Course of Rocuronium-Induced Neuromuscular Blockade in Pediatric Patients: A Phase III, Randomized, Dose-Response Study. J Anesthe Clin Res. 2012;3:189.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Assessor-blind, Dose-ranging, Phase IIIB, Multicenter Trial Comparing the Intubating Conditions and Time Course of Block of Three Different Intubating Doses (0.45 mg/kg, 0.6 mg/kg, and 1.0 mg/kg) of Zemuron® in Pediatric and Adolescent Subjects Under General Anesthesia
- ClinicalTrials.gov ID
- NCT00124722
- Acronym / sponsor ID
- P05798
- Conditions
- Anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 28 Jul 2005 (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 primary purpose of this study is to evaluate the time course of muscle relaxation after administration of three different single intravenous bolus doses of rocuronium bromide for intubation (insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation) in term neonates (birth to <28 days old), infants (28 days to <=3 months) and toddlers (>3 months to <=2 years), children (2 years to less than or equal to 11 years of age), and adolescents (>11 years to less than or equal to 17 years of age).
Subjects in each of the age groups will be randomized to one of 3 Zemuron® doses: 0.45 mg/kg, 0.6 mg/kg, or 1.0 mg/kg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.45 mg/kg Zemuron | Experimental | Drug: Rocuronium bromide (Zemuron)0.45 mg/kg Zemuron |
| 0.6 mg/kg Zemuron | Active comparator | Drug: Rocuronium bromide (Zemuron)0.6 mg/kg Zemuron |
| 1.0 mg/kg Zemuron | Experimental | Drug: Rocuronium bromide (Zemuron)1.0 mg/kg Zemuron |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Male and female subjects from birth up to 17 years of age who will be scheduled for surgery under general anesthesia.
Key exclusion criteria (1 listed)
- Subjects whose parent(s) or legal guardian(s) are not willing to give written consent and where applicable, subjects who have not given appropriate assent to participate in the trial will not be allowed to enter.
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 (Zemuron)Also: ORG 9426, SCH 900085, ZemuronA single IV Zemuron bolus dose of 0.45 mg/kg prior to intubation. | Drug | 0.45 mg/kg Zemuron |
| Rocuronium bromide (Zemuron)Also: ORG 9426, SCH 900085, ZemuronA single IV Zemuron bolus dose of 0.6 mg/kg prior to intubation. | Drug | 0.6 mg/kg Zemuron |
| Rocuronium bromide (Zemuron)Also: ORG 9426, SCH 900085, ZemuronA single IV Zemuron bolus dose of 1.0 mg/kg prior to intubation. | Drug | 1.0 mg/kg Zemuron |
Primary outcome
Time to reappearance of T3 (time from end-administration of Zemuron to reappearance of the third twitch of a TOF stimulation)
Time frame: during surgery
1 secondary outcome
Onset time, maximum block, time to reappearance of T1, Recovery to TOF 0.7, 0.8 and 0.9 and intubation score
Time frame: during and after surgery
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 1 Jun 2015.
- Results publicationTirotta CF, Brandom B, Siddiqui MS, Ehlers M, Betzel J, Chen J-Y, De Bie J, Blobner M. Time Course of Rocuronium-Induced Neuromuscular Blockade in Pediatric Patients: A Phase III, Randomized, Dose-Response Study. J Anesthe Clin Res. 2012;3:189.
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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 (Zemuron) 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 1 inclusion and 1 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 1 Jun 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?
Time to reappearance of T3 (time from end-administration of Zemuron to reappearance of the third twitch of a TOF stimulation) (time frame: during surgery). 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 NCT00124722, which also lists 1 linked publication.
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 1 Jun 2015.