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NCT03761277 · ClinicalTrials.gov registry record · Phase 4

Embrace TDD: Post-Market Study to Evaluate Intrathecal Morphine as an Alternative to Systemic Opioids for Chronic Pain

A Phase 4 study, sponsored by MedtronicNeuro.

Completed
Registry status
Phase 4
Development phase
93
Enrollment target

NCT03761277 is a Phase 4 study that has completed, run by MedtronicNeuro. The registered enrollment target is 93 participants.

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The verdict

NCT03761277, a Phase 4 study, has completed, sponsored by MedtronicNeuro.

COMPLETED
Registry status
Phase 4
Development phase
93 participants
Enrollment target

Study 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.

Interventions

  • DEVICE Medtronic SynchroMed™ II infusion system
  • DRUG Preservative-free morphine sulfate (PFMS)

Trial Details

FieldValue
Enrollment Target 93 participants
Start Date 2019-01-16
Est. Completion 2021-12-06
Phase Phase 4

Sponsor

MedtronicNeuro

51 total trials

What the Registry Record Tells You About NCT03761277

The ClinicalTrials.gov registry entry for NCT03761277 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MedtronicNeuro, which has 51 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Medtronic SynchroMed™ II infusion system is the first listed.

NCT03761277 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03761277 about?

NCT03761277 is a clinical study titled "Embrace TDD: Post-Market Study to Evaluate Intrathecal Morphine as an Alternative to Systemic Opioids for Chronic Pain". 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 ...

What is the current status of trial NCT03761277?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 93 participants. The study started on 2019-01-16. Estimated completion is 2021-12-06.

What interventions are being tested in trial NCT03761277?

The interventions under investigation include: Medtronic SynchroMed™ II infusion system (DEVICE), Preservative-free morphine sulfate (PFMS) (DRUG).

Who is sponsoring clinical trial NCT03761277?

This trial is sponsored by MedtronicNeuro, which has 51 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.