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Hydromorphone Pharmacokinetic-Pharmacodynamic Fingerprint

NCT01123486 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-04-22

No results posted yet for this study

Summary

The primary objective of the proposed work is development of a high resolution pharmacokinetic-pharmacodynamic (PK-PD) model of hydromorphone for experimental pain stimuli, ventilatory depression, and surrogate biomarkers of opioid effect that will allow the fingerprinting of hydromorphone. This fingerprint will serve as the basis for the development of dosing strategies that efficiently maximize analgesia while minimizing ventilatory depression and sedation. For example, this high-resolution fingerprint will allow precise estimation of an initial hydromorphone target effect site concentration (Ce) from those of effectively administered synthetic opioids with previously determined high-resolution fingerprints (i.e., remifentanil or fentanyl), thereby minimizing underdosing of hydromorphone for analgesia and minimizing side effects.

Conditions

  • Pain
  • Ventilatory Depression

Interventions

DRUG

hydromorphone

hydromorphone 0.02 mg/kg

Sponsors & Collaborators

Principal Investigators

  • Dhanesh K. Gupta, M.D. · Departments of Anesthesiology & Neurological Surgery, Northwestern University Feinberg School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01123486 on ClinicalTrials.gov