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NCT03201393 · ClinicalTrials.gov registry record · Phase 2

Low-Dose Naltrexone and Acetaminophen Combination in the Treatment of Chronic Low Back Pain (ANODYNE-4)

A Phase 2 study of Chronic Low Back Pain and Lumbar Radiculopathy, sponsored by Allodynic Therapeutics.

Completed
Registry status
Phase 2
Development phase
12
Enrollment target
1
Study location

NCT03201393 is a Phase 2 study of Chronic Low Back Pain and Lumbar Radiculopathy that has completed, run by Allodynic Therapeutics. The registered enrollment target is 12 participants, below the 592-participant average among 71 other Chronic Low Back Pain trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03201393, a Phase 2 study of Chronic Low Back Pain and Lumbar Radiculopathy, has completed, sponsored by Allodynic Therapeutics.

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

Study Summary

Treatment of chronic low-back pain with low-dose naltrexone and acetaminophen combination: a small, randomized, double-Blind, and placebo-controlled clinical trial with an open-label extension for none-responders

Conditions Studied

Chronic Low Back Pain Lumbar Radiculopathy

Interventions

  • DRUG Placebo
  • DRUG Low-dose naltrexone and acetaminophen combination

Study Locations (1)

Florida

  • Annette C. Toledano, M.D. - North Miami

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2017-08-15
Est. Completion 2018-07-26
Phase Phase 2

Sponsor

Allodynic Therapeutics

5 total trials

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What the Registry Record Tells You About NCT03201393

The ClinicalTrials.gov registry entry for NCT03201393 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 592-participant average among 71 other Chronic Low Back Pain trials with a reported enrollment target (98% lower). The listed sponsor is Allodynic Therapeutics, which has 5 total studies on file at ClinicalTrials.gov.

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

NCT03201393 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT03201393 about?

NCT03201393 is a clinical study titled "Low-Dose Naltrexone and Acetaminophen Combination in the Treatment of Chronic Low Back Pain (ANODYNE-4)". Treatment of chronic low-back pain with low-dose naltrexone and acetaminophen combination: a small, randomized, double-Blind, and placebo-controlled clinical trial with an open-label extension for none-responders

What is the current status of trial NCT03201393?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2017-08-15. Estimated completion is 2018-07-26.

What conditions does trial NCT03201393 study?

This clinical trial studies the following conditions: Chronic Low Back Pain, Lumbar Radiculopathy.

What interventions are being tested in trial NCT03201393?

The interventions under investigation include: Placebo (DRUG), Low-dose naltrexone and acetaminophen combination (DRUG).

Who is sponsoring clinical trial NCT03201393?

This trial is sponsored by Allodynic Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03201393 being conducted?

This trial has 1 study location across Florida. 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.