CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 93 enrolled
Drug / intervention
Preservative-free morphine sulfate (PFMS) +1 moredrug
Likely dose
Not stated in 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/NCT03761277
NCT03761277Phase 4Completed
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Embrace TDD: Prospective, Multi-Center, Post Market Study to Evaluate Intrathecal (IT) Morphine as an Alternative to Systemic Opioids for the Treatment of Chronic, Intractable, Non-Malignant Primary Back Pain With or Without Leg Pain

MedtronicNeuro·interventional·Posted Dec 3, 2018·Updated Feb 8, 2023

In Brief

A Phase 4 clinical trial evaluating Medtronic SynchroMed™ II infusion system and Preservative-free morphine sulfate (PFMS) for Chronic Non-malignant Pain and 3 related conditions. Completed, enrolled 93 participants across 16 sites.

Detailed Summary

This is a prospective, multi-center, post market study to evaluate Intrathecal (IT) preservative-free morphine sulfate (PFMS) using the SynchroMed™ II infusion system as an alternative to systemic opioids for the treatment of chronic, intractable, non-malignant primary back pain with or without leg pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Non-malignant Pain, Chronic Pain, Pain, Back, Pain, Leg
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedDec 3, 2018
Enrollment StartJan 16, 2019
Primary CompletionDec 6, 2021
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 7.6 years ago

Interventions

Medtronic SynchroMed™ II infusion systemdevice

Implanted infusion system consisting of a pump and catheter, as well as external components of a clinician programmer, refill and catheter access port kits, and the Personal Therapy Manager (myPTM™).

Preservative-free morphine sulfate (PFMS)drug

The pharmacological agent used in the pump for this study is limited to a preservative-free morphine sulfate (PFMS).