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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: Completed Phase 4 study, sponsored by MedtronicNeuro.
NCT03761277 is a Phase 4 study that has completed, run by MedtronicNeuro. The registered enrollment target is 93 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To characterize the number of subjects with Clinical Success at the 6-Month Visit. Clinical Success is defined as any of the following: 1) Reduced opioid-related side effects (at least a 20% reduction) with equal pain (less than 20% increase or decrease) 2) Reduced pain (at least a 20% reduction) with equal opioid-related side effects (less than 20% increase or decrease) 3) Reduced pain and reduced opioid-related side effects (at least a 20% reduction in both). The number of subjects with Clinic
Interventions
- DEVICE Medtronic SynchroMed™ II infusion system
- DRUG Preservative-free morphine sulfate (PFMS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2019-01-16 |
| Est. Completion | 2021-12-06 |
| Phase | Phase 4 |
What the finished NCT03761277 record still lists
NCT03761277 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Medtronic SynchroMed™ II infusion system is the first listed.
NCT03761277 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03761277's enrollment target sits among peer trials
93 874th of 2000 higher than 1,125 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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