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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: Completed Phase 2 study of Chronic Low Back Pain and Lumbar Radiculopathy, sponsored by Allodynic Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The mean weekly WPI score will be derived from assessments recorded by patients daily at bedtime. The WPI score is measured on the 11-point (0-10) Numeric Rating Scale (NRS), (0=no pain, 10=worst possible pain).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Low-dose naltrexone and acetaminophen combination
Study Locations (1)
Florida
- Annette C. Toledano, M.D. - North Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2017-08-15 |
| Est. Completion | 2018-07-26 |
| Phase | Phase 2 |
What the finished NCT03201393 record still lists
NCT03201393 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 592-participant average among 71 other Chronic Low Back Pain trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Chronic Low Back Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03201393's enrollment target sits among peer trials
12 72nd of 71 the lowest of 71 other Chronic Low Back Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Low Back Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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