Experimental Medicine Study to Validate Pharmacodynamic Pain Assessments in Healthy Volunteers With an Opioid Analgesic (Remifentanil)

NCT02602002 | Completed Phase 1

• 1 other identifier: 111000
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This was a single centre, randomised, double blind, placebo controlled, two-way cross-over design study to assess the feasibility of pain PD tests and to determine the variability and effects of a known analgesic drug (the opioid remifentanil) in South Korean healthy volunteers.

Conditions

Pain

Keywords

Remifentanil, Pharmacodynamic Pain assessments, Intravenous, South Korea

Outcome Measures

Primary Outcomes (1)

• To measure the Heat Pain Threshold of a marketed opioid analgesic versus placebo on quantitative experimental pharmacodynamic pain markers.

  Heat pain threshold

  pre-dose to 67 mins

Secondary Outcomes (3)

• 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

Study Arms (2)

Active

EXPERIMENTAL

Remifentanil 0.1 ug/kg/min to 0.10 ug/kg/min

Drug: Remifentanil

Placebo

PLACEBO COMPARATOR

Saline (0.9%)

Drug: Placebo

Interventions

Remifentanil DRUG

IV

Active

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 subject with a clinically significant abnormality or laboratory parameters outside the reference range for the relevant age group may be included only if the Investigator and Medical Monitor consider that the finding will not introduce additional risk factors and will not interfere with the study procedures.
• A normal 12-lead ECG recording at the pre-study medical.
• Signed and dated written and informed consent must be obtained for all subjects prior to admission to the study.
• The subject is able to understand and comply with the protocol requirements, instructions and protocol-stated restrictions.

You may not qualify if:

• The subject has a positive pre-study urine screen for drugs of abuse or positive alcohol test.
• Abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units. 1 unit is equivalent to a half-pint (220 mL) of beer or 1 (25 mL) measure of spirits or 1 glass (125 mL) of wine.
• Use of prescription drugs as well as vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless it is the opinion of the Investigator and Medical Monitor that the medication will not interfere with the study procedures or compromise subject safety.
• History or presence of allergy to the study drug or drugs of this class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
• Has a systolic blood pressure which is outside the range of 90 to 140 mmHg, diastolic blood pressure is outside the range of 50 to 90 mmHg or heart rate is outside the range 40 to 90 bpm.
• Has a QTcB \>450 msec.
• Has a significant medical history of dizziness, blackouts, fainting or vaso-vagal attacks.
• Has received over-the-counter (OTC) medicine within 48h before the first dosing day. Subjects who have taken OTC medication may still be entered into the study, if, in the opinion of the Principal/Co-Investigator, the medication received will not interfere with the study procedures or compromise safety.
• Has a history or presence of gastro-intestinal, hepatic or renal disease or other condition known to interfere with the distribution, metabolism or excretion of drugs.
• The subject has received an investigational drug or participated in any other research trial within 84 days for new chemical entities and marketed drugs or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Pain

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2012
• First Posted: November 11, 2015
• Study Start: April 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: November 11, 2015

Record last verified: 2015-11

Locations

KR (1)