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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 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.

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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.

Conditions Studied

Pain, Chronic Pain, Intractable Chronic Nonmalignant Pain

Interventions

  • DEVICE Flowonix Prometra® II Programmable Infusion System
  • DRUG Pain Medicine

Study Locations (1)

California

  • Evolve Restorative Center - Santa Rosa

Trial Details

FieldValue
Enrollment Target 73 participants
Start Date 2019-06-05
Est. Completion 2022-04-11
Phase NA

Sponsor

Evolve Restorative Center

1 total trials

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What the Registry Record Tells You About NCT04096391

The ClinicalTrials.gov registry entry for NCT04096391 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 720-participant average among 48 other Pain, Chronic trials with a reported enrollment target (90% lower). The listed sponsor is Evolve Restorative Center, which has 1 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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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.