AnesthesiaPhase 3NCT00421148

Dose-Finding Pediatric and Adult Trial With Sugammadex (Org 25969, MK-8616, SCH 900616) (19.4.306) (MK-8616-034) (P05961)

A Phase 3 study testing Sugammadex 0.5 mg/kg, Sugammadex 1 mg/kg and Sugammadex 2 mg/kg 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 explore the dose-response relation of sugammadex (Org 25969, MK-8616, SCH 900616) given as a reversal agent at reappearance of T2 after 0.6 mg.kg-1 rocuronium in pediatric and adult participants to explore the pharmacokinetics (PK) of sugammadex in pediatric and adult participants, and… Read more about this study

Who is it for?: Ages 28 days to 65 years
Conditions the study is for: Anesthesia
What is being tested?: Sugammadex 0.5 mg/kg, Sugammadex 1 mg/kg and Sugammadex 2 mg/kg
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 94 participants
Where: No sites listed yet
Study dates: 30 May 2005to 2 Jun 2006
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 28 days to 65 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

American Society of Anesthesiologists (ASA) class 1 - 2, between the ages of 28 days and 65 years inclusive, and between the ages of 2 and 65 years inclusive for Germany and between the ages of 6 and 65 years inclusive for Finland
Scheduled for general anesthesia with an anticipated duration of anesthesia of at least 60 minutes, without further need for muscle relaxation other than one single dose of 0.6 mg/kg rocuronium
Scheduled for surgical procedures in the supine position
Participants who, and/or whose parent(s) or legal guardian(s) have given written informed consent [or appropriate assent, if applicable]

Who cannot join

Known or suspected neuromuscular disorders impairing neuromuscular blockade (NMB) and/or significant renal dysfunction, in Germany creatinine and blood urea nitrogen outside local reference ranges
Known or suspected to have a (family) history of malignant hyperthermia
Known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia
Use of medication expected to interfere with the rocuronium given in this trial, based on the dose and the time of administration
Pregnancy
Childbearing potential not using any of the following methods of birth control: condom or diaphragm with spermicide, vasectomized partner (>6 months), intrauterine device (IUD), abstinence

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Breast-feeding
Prior participation in any study with Org 25969 (sugammadex)
Participation in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into study 19.4.306 (MK-8616-034, P05961)

About this study

Official title: A Multi-Center, Randomized, Parallel Dose-Finding, Safety Assessor-Blinded Trial to Explore the Efficacy, Safety and Pharmacokinetics of Four Doses of Org 25969 and Placebo in Pediatric and Adult Subjects.

The purpose of this study is:

to explore the dose-response relation of sugammadex (Org 25969, MK-8616, SCH 900616) given as a reversal agent at reappearance of T2 after 0.6 mg.kg-1 rocuronium in pediatric and adult participants
to explore the pharmacokinetics (PK) of sugammadex in pediatric and adult participants, and to evaluate the safety of sugammadex in pediatric and adult participants.

Conditions: Anesthesia
Being tested: Sugammadex 0.5 mg/kg, Sugammadex 1 mg/kg, Sugammadex 2 mg/kg, Sugammadex 4 mg/kg, Placebo

What participants receive

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

Sugammadex 0.5 mg/kgDrug
Also called Org 25969, MK-8616, SCH 900616
IV infusion
Sugammadex 1 mg/kgDrug
Also called Org 25969, MK-8616, SCH 900616
IV infusion
Sugammadex 2 mg/kgDrug
Also called Org 25969, MK-8616, SCH 900616
IV infusion
Sugammadex 4 mg/kgDrug
Also called Org 25969, MK-8616, SCH 900616
IV infusion
PlaceboDrug
Also called sodium chloride 0.9% solution
IV infusion
Rocuronium bromideDrug
Also called ESMERON®
IV infusion

Study groups in NCT00421148
Study group	Role	What they receive
Sugammadex 0.5 mg/kg	Experimental	Participants are to receive an intravenous (IV) single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex is to be given. Receives: Drug: Sugammadex 0.5 mg/kg; Drug: Rocuronium bromide
Sugammadex 1 mg/kg	Experimental	Participants are to receive an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex is to be given. Receives: Drug: Sugammadex 1 mg/kg; Drug: Rocuronium bromide
Sugammadex 2 mg/kg	Experimental	Participants are to receive an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex is to be given. Receives: Drug: Sugammadex 2 mg/kg; Drug: Rocuronium bromide
Sugammadex 4 mg/kg	Experimental	Participants are to receive an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex is to be given. Receives: Drug: Sugammadex 4 mg/kg; Drug: Rocuronium bromide
Placebo	Placebo comparator	Participants are to receive an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single 3-mL bolus dose of placebo (sodium chloride 0.9% solution) is to be given. Receives: Drug: Placebo; Drug: Rocuronium bromide

What is being measured

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

Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9
Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds \& assessing twitch response at the adductor pollicis muscle. T1 \& T4 refer to the magnitudes (heights) of the first \& fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached ≥0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.
Measured: From start of sugammadex or palcebo administration to recovery of T4/T1 ratio to 0.9 (ranging from ~0.5 minutes to ~30 minutes from sugammadex or placebo administration)

Secondary outcomes (2)

Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7
Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds \& assessing twitch response at the adductor pollicis muscle. T1 \& T4 refer to the magnitudes (heights) of the first \& fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB.
Measured: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.7 (ranging from ~0.4 minutes to ~20 minutes from sugammadex or placebo administration)
Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8
Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds \& assessing twitch response at the adductor pollicis muscle. T1 \& T4 refer to the magnitudes (heights) of the first \& fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB.
Measured: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.8 (ranging from ~0.5 minutes to ~25 minutes from sugammadex or placebo administration)

Timeline

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

30 May 20052 Jun 2006

First posted11 Jan 2007 (estimated)
Study start30 May 2005
Primary completion31 May 2006
Study completion2 Jun 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00421148
Sponsor's protocol ID: P05961
Other IDs: 2004-003819-23, 19.4.306, MK-8616-034, P05961, 2004
Status last verified: Aug 2018
First submitted: 8 Jan 2007
Last updated: 28 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Plaud B, Meretoja O, Hofmockel R, Raft J, Stoddart PA, van Kuijk JH, Hermens Y, Mirakhur RK. Reversal of rocuronium-induced neuromuscular blockade with sugammadex in pediatric and adult surgical patients. Anesthesiology. 2009 Feb;110(2):284-94. doi: 10.1097/ALN.0b013e318194caaa.
PubMed 19194156

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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All Anesthesia trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Randomized, Parallel Dose-Finding, Safety Assessor-Blinded Trial to Explore the Efficacy, Safety and Pharmacokinetics of Four Doses of Org 25969 and Placebo in Pediatric and Adult Subjects.
ClinicalTrials.gov ID: NCT00421148
Acronym / sponsor ID: P05961
Conditions: Anesthesia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 30 May 2005 (actual)
Primary completion: 31 May 2006 (actual)
Study completion: 2 Jun 2006 (actual)
First posted: 11 Jan 2007 (estimated)
Results: Posted 28 Jan 2019

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 explore the dose-response relation of sugammadex (Org 25969, MK-8616, SCH 900616) given as a reversal agent at reappearance of T2 after 0.6 mg.kg-1 rocuronium in pediatric and adult participants
to explore the pharmacokinetics (PK) of sugammadex in pediatric and adult participants, and to evaluate the safety of sugammadex in pediatric and adult participants.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Sugammadex 0.5 mg/kg	Experimental	Drug: Sugammadex 0.5 mg/kg, Drug: Rocuronium bromideParticipants are to receive an intravenous (IV) single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex is to be given.
Sugammadex 1 mg/kg	Experimental	Drug: Sugammadex 1 mg/kg, Drug: Rocuronium bromideParticipants are to receive an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex is to be given.
Sugammadex 2 mg/kg	Experimental	Drug: Sugammadex 2 mg/kg, Drug: Rocuronium bromideParticipants are to receive an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex is to be given.
Sugammadex 4 mg/kg	Experimental	Drug: Sugammadex 4 mg/kg, Drug: Rocuronium bromideParticipants are to receive an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex is to be given.
Placebo	Placebo comparator	Drug: Placebo, Drug: Rocuronium bromideParticipants are to receive an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single 3-mL bolus dose of placebo (sodium chloride 0.9% solution) is to be given.

Who may qualify

Ages: 28 days to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

American Society of Anesthesiologists (ASA) class 1 - 2, between the ages of 28 days and 65 years inclusive, and between the ages of 2 and 65 years inclusive for Germany and between the ages of 6 and 65 years inclusive for Finland
Scheduled for general anesthesia with an anticipated duration of anesthesia of at least 60 minutes, without further need for muscle relaxation other than one single dose of 0.6 mg/kg rocuronium
Scheduled for surgical procedures in the supine position
Participants who, and/or whose parent(s) or legal guardian(s) have given written informed consent [or appropriate assent, if applicable]

Key exclusion criteria (9 listed)

Known or suspected neuromuscular disorders impairing neuromuscular blockade (NMB) and/or significant renal dysfunction, in Germany creatinine and blood urea nitrogen outside local reference ranges
Known or suspected to have a (family) history of malignant hyperthermia
Known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia
Use of medication expected to interfere with the rocuronium given in this trial, based on the dose and the time of administration
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
Sugammadex 0.5 mg/kgAlso: Org 25969, MK-8616, SCH 900616IV infusion	Drug	Sugammadex 0.5 mg/kg
Sugammadex 1 mg/kgAlso: Org 25969, MK-8616, SCH 900616IV infusion	Drug	Sugammadex 1 mg/kg
Sugammadex 2 mg/kgAlso: Org 25969, MK-8616, SCH 900616IV infusion	Drug	Sugammadex 2 mg/kg
Sugammadex 4 mg/kgAlso: Org 25969, MK-8616, SCH 900616IV infusion	Drug	Sugammadex 4 mg/kg
PlaceboAlso: sodium chloride 0.9% solutionIV infusion	Drug	Placebo
Rocuronium bromideAlso: ESMERON®IV infusion	Drug	Placebo, Sugammadex 0.5 mg/kg, Sugammadex 1 mg/kg, Sugammadex 2 mg/kg, Sugammadex 4 mg/kg

Primary outcome

Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9
Time frame: From start of sugammadex or palcebo administration to recovery of T4/T1 ratio to 0.9 (ranging from ~0.5 minutes to ~30 minutes from sugammadex or placebo administration)
Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds \& assessing twitch response at the adductor pollicis muscle. T1 \& T4 refer to the magnitudes (heights) of the first \& fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached ≥0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.

2 secondary outcomes

Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7
Time frame: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.7 (ranging from ~0.4 minutes to ~20 minutes from sugammadex or placebo administration)
Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8
Time frame: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.8 (ranging from ~0.5 minutes to ~25 minutes from sugammadex or placebo administration)

Results and safety

Results posted to the registry on 28 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Infants: Placebo	2	2
Infants: Sugammadex 0.5 mg/kg	2	2
Infants: Sugammadex 1 mg/kg	2	2
Infants: Sugammadex 2 mg/kg	1	1
Infants: Sugammadex 4 mg/kg	1	1
Children: Placebo	5	4
Children: Sugammadex 0.5 mg/kg	6	6
Children: Sugammadex 1 mg/kg	5	5
Children: Sugammadex 2 mg/kg	5	5
Children: Sugammadex 4 mg/kg	5	5
Adolescents: Placebo	6	6
Adolescents: Sugammadex 0.5 mg/kg	6	6
Adolescents: Sugammadex 1 mg/kg	6	6
Adolescents: Sugammadex 2 mg/kg	6	6
Adolescents: Sugammadex 4 mg/kg	6	6
Adults: Placebo	6	6
Adults: Sugammadex 0.5 mg/kg	6	6
Adults: Sugammadex 1 mg/kg	6	4
Adults: Sugammadex 2 mg/kg	6	5
Adults: Sugammadex 4 mg/kg	6	6

Primary outcome: Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9

Time frame: From start of sugammadex or palcebo administration to recovery of T4/T1 ratio to 0.9 (ranging from ~0.5 minutes to ~30 minutes from sugammadex or placebo administration). Mean (Standard Deviation). Unit: Minutes

Measure	Infants: Placebo n = 2	Infants: Sugammadex 0.5 mg/kg n = 2	Infants: Sugammadex 1 mg/kg n = 2	Infants: Sugammadex 2 mg/kg n = 1	Children: Placebo n = 4	Children: Sugammadex 0.5 mg/kg n = 5	Children: Sugammadex 1 mg/kg n = 5	Children: Sugammadex 2 mg/kg n = 4	Children: Sugammadex 4 mg/kg n = 4	Adolescents: Placebo n = 5	Adolescents: Sugammadex 0.5 mg/kg n = 5	Adolescents: Sugammadex 1 mg/kg n = 6	Adolescents: Sugammadex 2 mg/kg n = 6	Adolescents: Sugammadex 4 mg/kg n = 6	Adults: Placebo n = 6	Adults: Sugammadex 0.5 mg/kg n = 5	Adults: Sugammadex 1 mg/kg n = 5	Adults: Sugammadex 2 mg/kg n = 5	Adults: Sugammadex 4 mg/kg n = 5	Infants: Sugammadex 4 mg/kg n = 1
Value	20.98 (11.30)	3.72 (0.63)	2.42 (0.70)	0.58 (NA)	19.57 (10.97)	5.22 (3.50)	3.95 (3.23)	1.20 (0.35)	1.57 (1.90)	22.77 (13.10)	11.97 (17.65)	1.77 (0.37)	1.87 (1.70)	1.08 (0.25)	29.48 (8.43)	3.77 (1.12)	1.62 (0.30)	1.27 (0.27)	1.37 (0.38)	0.67 (NA)

Population analysed: The Per Protocol (PP) population consisted of all randomized participants who received a dose of study treatment (sugammadex or placebo) \& had ≥1 post-baseline efficacy measurement for this outcome measure \& had no protocol violations. For efficacy, participants with incorrect randomization were included under the planned dose group.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through postoperative Day 7 (Up to 8 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Infants: Placebo	0 of 2 (0%)	2 of 2 (100%)	0 of 2
Infants: Sugammadex .0.5 mg/kg	1 of 2 (50%)	1 of 2 (50%)	0 of 2
Infants: Sugammadex 1 mg/kg	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Infants: Sugammadex 2 mg/kg	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Infants: Sugammadex 4 mg/kg	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Children: Placebo	0 of 4 (0%)	3 of 4 (75%)	0 of 4
Children: Sugammadex 0.5 mg/kg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Children: Sugammadex 1 mg/kg	0 of 5 (0%)	2 of 5 (40%)	0 of 5
Children: Sugammadex 2 mg/kg	0 of 5 (0%)	2 of 5 (40%)	0 of 5
Children: Sugammadex 4 mg/kg	1 of 4 (25%)	4 of 4 (100%)	0 of 4
Adolescents: Placebo	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Adolescents: Sugammadex 0.5 mg/kg	0 of 5 (0%)	3 of 5 (60%)	0 of 5
Adolescents: Sugammadex 1 mg/kg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Adolescents: Sugammadex 2 mg/kg	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Adolescents: Sugammadex 4 mg/kg	0 of 8 (0%)	5 of 8 (62.5%)	0 of 8
Adults: Placebo	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Adults: Sugammadex 0.5 mg/kg	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Adults: Sugammadex 1 mg/kg	0 of 5 (0%)	5 of 5 (100%)	0 of 5
Adults: Sugammadex 2 mg/kg	0 of 5 (0%)	4 of 5 (80%)	0 of 5
Adults: Sugammadex 4 mg/kg

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19194156Plaud B, Meretoja O, Hofmockel R, Raft J, Stoddart PA, van Kuijk JH, Hermens Y, Mirakhur RK. Reversal of rocuronium-induced neuromuscular blockade with sugammadex in pediatric and adult surgical patients. Anesthesiology. 2009 Feb;110(2):284-94. doi: 10.1097/ALN.0b013e318194caaa.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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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.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sugammadex 0.5 mg/kg, Sugammadex 1 mg/kg and Sugammadex 2 mg/kg 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 4 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 28 Jan 2019. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 28 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9 (time frame: From start of sugammadex or palcebo administration to recovery of T4/T1 ratio to 0.9 (ranging from ~0.5 minutes to ~30 minutes from sugammadex or placebo administration)). 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 NCT00421148, 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 28 Jan 2019.