Low-Dose Naltrexone and Acetaminophen Combination in the Treatment of Chronic Low Back Pain (ANODYNE-4)
Public ClinicalTrials.gov record NCT03201393. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Single Site, Phase 2B, Randomized, Double-Blind, Study to Assess the Efficacy, Safety, and Tolerability of Low-Dose Naltrexone and Acetaminophen Combination vs. Placebo in the Treatment of Chronic Low Back Pain (ANODYNE-4)
Study identification
- NCT ID
- NCT03201393
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Allodynic Therapeutics, Inc
- Industry
- Enrollment
- 12 participants
Conditions and interventions
Conditions
Interventions
- Low-dose naltrexone and acetaminophen combination Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 14, 2017
- Primary completion
- Jul 25, 2018
- Completion
- Jul 25, 2018
- Last update posted
- Apr 13, 2021
2017 – 2018
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Annette C. Toledano, M.D. | North Miami | Florida | 33181 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03201393, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 13, 2021 · Synced May 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03201393 live on ClinicalTrials.gov.