Anesthesia, GeneralPhase 3NCT00482599
Efficacy, Pharmacokinetics and Safety of Org 25969 in Subjects With Normal or Impaired Renal Function (19.4.304)(P05948)(COMPLETED)
A Phase 3 study testing Sugammadex in people with Anesthesia, General, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to compare the efficacy and pharmacokinetics of Org 25969 in subjects with normal or impaired renal function and to evaluate the safety of Org 25969 in subjects with impaired renal function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, General
- What is being tested?
- Sugammadex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2005to 13 Apr 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA class 1 - 3 for renally impaired patients, ASA class 1-2 for control group
- Age at least 18 years
- Scheduled for general anesthesia without further need for muscle relaxation other than one single dose of 0.6 mg.kg-1 rocuronium
- Scheduled for surgical procedures in the supine position
- Written informed consent
- Creatinine clearance (CLCR) < 30 mL/min for renally impaired group, CLCR = 80 mL/min for control group
Who cannot join
- Known or suspected neuromuscular disorders impairing NMB
- Known or suspected (family) history of malignant hyperthermia
- Known or suspected allergy to narcotics, muscle relaxants or other medication used during general anesthesia
- Use of medication known to interfere with NMBA based on the dose and the time of administration, such as antibiotics, anticonvulsants and Mg2+
- Pregnancy
- Childbearing potential without using any of the following methods of birth control: condom or diaphragm with spermicide, vasectomized partner ( > 6 months), intrauterine device, abstinence
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- Breast-feeding
- Prior participation in any trial with Org 25969
- Participation in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into trial 19.4.304, or for the UK only: Participation in another clinical trial, within 30 days of entering into trial 19.4.304.
About this study
Official title: A Multicenter, Parallel Group, Comparative Trial Evaluating the Efficacy, Pharmacokinetics and Safety of Org 25969 in Subjects With Normal or Impaired Renal Function
The purpose of this study is to compare the efficacy and pharmacokinetics of Org 25969 in subjects with normal or impaired renal function and to evaluate the safety of Org 25969 in subjects with impaired renal function.
- Conditions
- Anesthesia, General
- Being tested
- Sugammadex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
Also called Org 25969
2 mg/kg sugammadex administered intravenously at reappearance of T2 after 0.6 mg/kg rocuronium in patients with renal impairment and control patients
| Study group | Role | What they receive |
|---|---|---|
| Normal renal function | Active comparator | Org 25969 given to subjects with normal renal function Receives: Drug: Sugammadex |
| Impaired renal function | Experimental | Org 25969 given to subjects with impaired renal function Receives: Drug: Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.9
Measured: After surgery
Secondary outcomes (1)
Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.7 and 0.8
Measured: After surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2007 (estimated)
- Study start1 Jun 2005
- Primary completion13 Apr 2006
- Study completion13 Apr 2006
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 Anesthesia, GeneralStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT00482599
- Sponsor's protocol ID
- P05948
- Other IDs
- 19.4.304
- Status last verified
- Jun 2017
- First submitted
- 4 Jun 2007
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Staals LM, Snoeck MM, Driessen JJ, van Hamersvelt HW, Flockton EA, van den Heuvel MW, Hunter JM. Reduced clearance of rocuronium and sugammadex in patients with severe to end-stage renal failure: a pharmacokinetic study. Br J Anaesth. 2010 Jan;104(1):31-9. doi: 10.1093/bja/aep340.
PubMed 20007792
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Parallel Group, Comparative Trial Evaluating the Efficacy, Pharmacokinetics and Safety of Org 25969 in Subjects With Normal or Impaired Renal Function
- ClinicalTrials.gov ID
- NCT00482599
- Acronym / sponsor ID
- P05948
- Conditions
- Anesthesia, General
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2005 (actual)
- Primary completion
- 13 Apr 2006 (actual)
- Study completion
- 13 Apr 2006 (actual)
- First posted
- 5 Jun 2007 (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 efficacy and pharmacokinetics of Org 25969 in subjects with normal or impaired renal function and to evaluate the safety of Org 25969 in subjects with impaired renal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal renal function | Active comparator | Drug: SugammadexOrg 25969 given to subjects with normal renal function |
| Impaired renal function | Experimental | Drug: SugammadexOrg 25969 given to subjects with impaired renal function |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ASA class 1 - 3 for renally impaired patients, ASA class 1-2 for control group
- Age at least 18 years
- Scheduled for general anesthesia without further need for muscle relaxation other than one single dose of 0.6 mg.kg-1 rocuronium
- Scheduled for surgical procedures in the supine position
- Written informed consent
Key exclusion criteria (9 listed)
- Known or suspected neuromuscular disorders impairing NMB
- Known or suspected (family) history of malignant hyperthermia
- Known or suspected allergy to narcotics, muscle relaxants or other medication used during general anesthesia
- Use of medication known to interfere with NMBA based on the dose and the time of administration, such as antibiotics, anticonvulsants and Mg2+
- Pregnancy
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 |
|---|---|---|
| SugammadexAlso: Org 259692 mg/kg sugammadex administered intravenously at reappearance of T2 after 0.6 mg/kg rocuronium in patients with renal impairment and control patients | Drug | Impaired renal function, Normal renal function |
Primary outcome
Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.9
Time frame: After surgery
1 secondary outcome
Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.7 and 0.8
Time frame: 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 16 Jun 2017.
- Derived from this study: PubMed 20007792Staals LM, Snoeck MM, Driessen JJ, van Hamersvelt HW, Flockton EA, van den Heuvel MW, Hunter JM. Reduced clearance of rocuronium and sugammadex in patients with severe to end-stage renal failure: a pharmacokinetic study. Br J Anaesth. 2010 Jan;104(1):31-9. doi: 10.1093/bja/aep340.
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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 Sugammadex in people with Anesthesia, General, 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 9 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 16 Jun 2017. 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 from start administration of Org 25969 to recovery T4/T1 ratio to 0.9 (time frame: After 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 NCT00482599, 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 16 Jun 2017.