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Remifentanil

Phase 1

Pain | Small molecule | Pain |GSK plc|Last Updated: Nov 11, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

Remifentanil · 1 trial · 1 indication

Phase 1 1
NCT02602002Experimental Medicine Study to Validate Pharmacodynamic Pain Assessments in Healthy Volunteers With an Opioid Analgesic (Remifentanil)Pain
COMPLETED20 Analytics
PHASE1COMPLETED
Experimental Medicine Study to Validate Pharmacodynamic Pain Assessments in Healthy Volunteers With an Opioid Analgesic (Remifentanil)
Pain
NCT0260200220
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Study Endpoints

Primary Endpoints

To measure the Heat Pain Threshold of a marketed opioid analgesic versus placebo on quantitative experimental pharmacodynamic pain markers.
pre-dose to 67 mins

Heat pain threshold

Secondary Endpoints

To measure the Mechanical Pain Threshold of a marketed opioid analgesic versus placebo. on quantitative experimental pharmacodynamic pain markers.
Change from Baseline (pre-dose) in mechanical pain thresholds measurements at 46 minutes
To measure the Pressure Pain Threshold of a marketed opioid analgesic versus placebo on quantitative pharmacodynamic experimental pain markers.
Change from Baseline (pre-dose) in mechanical pain thresholds measurements at 46mins
To measure the Mood and Alertness of a marketed opioid analgesic versus placebo on alertness on quantitative pharmacodynamic experimental pain markers.
Change from Baseline (Pre-dose) in pressure pain thresholds and tolerance measurements at 46mins, 67 minutes
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
ActiveEXPERIMENTALRemifentanil 0.1 ug/kg/min to 0.10 ug/kg/min
PlaceboPLACEBO_COMPARATORSaline (0.9%)

Interventions

NameTypeDescription
RemifentanilDRUGIV
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range20 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Non-smoking, healthy adult male, aged 20-45 years inclusive. * Body weight \>50 Kg and BMI within the range 18.5-29.9 Kg/m2 inclusive * Healthy as judged by a responsible physician. No clinically significant abnormality identified on the medical or laboratory evaluation. A sub...

Countries:South Korea
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Frequently asked questions about Remifentanil

What is Remifentanil used for?

Remifentanil is an investigational small molecule being studied for the treatment of pain. It is currently in Phase 1 clinical development. The drug is being evaluated in a completed experimental medicine study that aimed to validate pharmacodynamic pain assessments in healthy volunteers using an opioid analgesic.

Who makes Remifentanil?

Remifentanil is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical research on this small molecule for pain indications. The drug is currently in Phase 1 development.

What phase is Remifentanil in?

Remifentanil is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. A single Phase 1 trial has been completed, which enrolled 20 healthy male volunteers in South Korea to study the drug's pharmacodynamic effects on pain assessments.

What clinical trials is Remifentanil in?

Remifentanil has one completed clinical trial registered under NCT02602002. The study was titled "Experimental Medicine Study to Validate Pharmacodynamic Pain Assessments in Healthy Volunteers With an Opioid Analgesic (Remifentanil)" and enrolled 20 healthy male participants aged 20 years and older in South Korea.

Is Remifentanil FDA approved?

Remifentanil is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug has completed one early-stage trial, but it has not yet received regulatory approval for the treatment of pain.