CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 13 enrolled
Drug / intervention
Methadone hydrochloride +1 moredrug
Likely dose
Methadone hydrochloride 4mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03525509
NCT03525509Early Ph 1Completed

Investigation of Pharmacokinetics and Pharmacodynamics of Epidural Methadone in Healthy Volunteers

simon.haroutounian·interventional·Posted May 15, 2018·Updated Sep 18, 2019

In Brief

A Early Phase 1 clinical trial evaluating Methadone hydrochloride and Morphine Sulfate for Pain, Acute. Completed, enrolled 13 participants across 1 site.

Detailed Summary

Epidurally administered opioid pain medications are important tools for postoperative pain control, but each agent has its own limitations. Methadone's properties suggest that it may provide a long duration of pain control with minimal side effects related to spread to the brain or absorption into the blood stream. In this study, the investigators aim to compare the relative pain relieving effects, markers of side effects, and concentrations in the blood of epidurally administered methadone as compared to another long-acting opioid which is commonly administered epidurally, morphine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Acute
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
20192020202120222023202420252026
First PostedMay 15, 2018
Enrollment StartJun 4, 2018
Primary CompletionAug 28, 2019
Study CompletionAug 30, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 8.1 years ago

Interventions

Methadone hydrochloridedrug

Epidural bolus of 4mg of preservative free methadone hydrochloride (4mL of 1mg/mL solution)

Morphine Sulfatedrug

Epidural bolus of 4mg of preservative free morphine sulfate (4mL of 1mg/mL solution)