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NCT04096391 · ClinicalTrials.gov registry record · NA
Post-market, Randomized, Controlled, Prospective Study Evaluating Intrathecal Pain Medication (IT) Versus Conventional Medical Management (CMM) in the Non-cancer, Refractory, Chronic Pain Population
A NA study of Pain, Chronic and Pain, Intractable, sponsored by Evolve Restorative Center.
- Completed
- Registry status
- NA
- Development phase
- 73
- Enrollment target
- 1
- Study location
NCT04096391: Completed NA study of Pain, Chronic and Pain, Intractable, sponsored by Evolve Restorative Center.
NCT04096391 is a NA study of Pain, Chronic and Pain, Intractable that has completed, run by Evolve Restorative Center. The registered enrollment target is 73 participants, below the 720-participant average among 48 other Pain, Chronic trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04096391, a NA study of Pain, Chronic and Pain, Intractable, has completed, sponsored by Evolve Restorative Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 73 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is being conducted to compare intrathecal morphine using the commercially available intrathecal drug delivery systems (IDDS), and conventional medical management (CMM) in subjects with non-cancer, refractory chronic pain.
Primary Outcome
The Numeric Pain Rating Scale (NPRS) is a 0-10 numeric pain rating scale (11 point scale), where a higher scores equates to more pain. The primary endpoint for this post-marketing study is the comparison of the NPRS between the IDDS group and the CMM group collected in the Study Diary at various time points.
Conditions Studied
Interventions
- DEVICE Flowonix Prometra® II Programmable Infusion System
- DRUG Pain Medicine
Study Locations (1)
California
- Evolve Restorative Center - Santa Rosa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2019-06-05 |
| Est. Completion | 2022-04-11 |
| Phase | NA |
What the finished NCT04096391 record still lists
NCT04096391 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 720-participant average among 48 other Pain, Chronic trials with a reported enrollment target (90% lower).
The record links to 3 conditions, with Pain, Chronic appearing as the primary indexed condition, and to 2 interventions - of which Flowonix Prometra® II Programmable Infusion System is the first listed.
NCT04096391 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04096391 about?
NCT04096391 is a clinical study titled "Post-market, Randomized, Controlled, Prospective Study Evaluating Intrathecal Pain Medication (IT) Versus Conventional Medical Management (CMM) in the Non-cancer, Refractory, Chronic Pain Population". This study is being conducted to compare intrathecal morphine using the commercially available intrathecal drug delivery systems (IDDS), and conventional medical management (CMM) in subjects with non-cancer, refractory chronic pain.
What is the current status of trial NCT04096391?
This trial is currently completed. It is a NA study. The enrollment target is 73 participants. The study started on 2019-06-05. Estimated completion is 2022-04-11.
What conditions does trial NCT04096391 study?
This clinical trial studies the following conditions: Pain, Chronic, Pain, Intractable, Chronic Nonmalignant Pain.
What interventions are being tested in trial NCT04096391?
The interventions under investigation include: Flowonix Prometra® II Programmable Infusion System (DEVICE), Pain Medicine (DRUG).
Who is sponsoring clinical trial NCT04096391?
This trial is sponsored by Evolve Restorative Center, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04096391 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pain, Chronic
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04096391's enrollment target sits among peer trials
73 29th of 48 higher than 20 of 48 other Pain, Chronic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain, Chronic 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.
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