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NCT03008590 · ClinicalTrials.gov registry record · Phase 2

Low Dose Naltrexone for Chronic Pain From Arthritis

A Phase 2 study of Osteoarthritis and Arthritis, Rheumatoid, sponsored by VA Office of Research and Development.

Completed
Registry status
Phase 2
Development phase
29
Enrollment target
1
Study location

NCT03008590 is a Phase 2 study of Osteoarthritis and Arthritis, Rheumatoid that has completed, run by VA Office of Research and Development. The registered enrollment target is 29 participants, below the 818-participant average among 135 other Osteoarthritis trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03008590, a Phase 2 study of Osteoarthritis and Arthritis, Rheumatoid, has completed, sponsored by VA Office of Research and Development.

COMPLETED
Registry status
Phase 2
Development phase
29 participants
Enrollment target
1
Study location

Study Summary

Over 100 million Americans report chronic pain. Veterans are disproportionately affected for multiple reasons, including injuries and post-traumatic stress disorder. Treatment for chronic pain is a priority research area for the VA. One of the most common causes of chronic pain is osteoarthritis (OA). OA is attributable to "wear and tear," but reasons for pain are complex. Inflammatory arthritis (IA) includes multiple severe diseases that affect 2-3% of persons and require treatment with immune-suppressive drugs to prevent joint destruction. Pain often persists despite effective treatment. Pain in arthritis results from multiple sources: inflammation, perception of pain in the joint, and interpretation of pain by the brain. Unfortunately, management of pain in arthritis remains a challenge. Low dose naltrexone is a widely used but unproven "alternative" approach to chronic pain. It is attractive for study because it is safe and is proposed to work on all three pathways that contribute to pain. A small but high-quality clinical trial is needed to determine whether to invest in definitive studies.

Conditions Studied

Osteoarthritis Arthritis, Rheumatoid Arthritis, Psoriatic

Interventions

  • DRUG Placebo
  • DRUG Naltrexone

Study Locations (1)

Massachusetts

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA - Boston

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2018-05-01
Est. Completion 2019-12-31
Phase Phase 2

Sponsor

VA Office of Research and Development

1,668 total trials

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What the Registry Record Tells You About NCT03008590

The ClinicalTrials.gov registry entry for NCT03008590 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 818-participant average among 135 other Osteoarthritis trials with a reported enrollment target (96% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Osteoarthritis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03008590 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT03008590 about?

NCT03008590 is a clinical study titled "Low Dose Naltrexone for Chronic Pain From Arthritis". Over 100 million Americans report chronic pain. Veterans are disproportionately affected for multiple reasons, including injuries and post-traumatic stress disorder. Treatment for chronic pain is a priority research area for the VA. One of the most common causes of chronic pain is osteoarthritis (OA...

What is the current status of trial NCT03008590?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2018-05-01. Estimated completion is 2019-12-31.

What conditions does trial NCT03008590 study?

This clinical trial studies the following conditions: Osteoarthritis, Arthritis, Rheumatoid, Arthritis, Psoriatic.

What interventions are being tested in trial NCT03008590?

The interventions under investigation include: Placebo (DRUG), Naltrexone (DRUG).

Who is sponsoring clinical trial NCT03008590?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03008590 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.