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

NCT03201393 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-04-14

No results posted yet for this 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

  • Chronic Low Back Pain
  • Lumbar Radiculopathy

Interventions

DRUG

Low-dose naltrexone and acetaminophen combination

Twice a day

DRUG

Placebo

Twice a day

Sponsors & Collaborators

  • Allodynic Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • Annette Toledano, M.D. · Allodynic Therapeutics, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-15
Primary Completion
2018-07-26
Completion
2018-07-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03201393 on ClinicalTrials.gov