Trials / Completed
CompletedNCT03201393
Low-Dose Naltrexone and Acetaminophen Combination in the Treatment of Chronic Low Back Pain (ANODYNE-4)
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Allodynic Therapeutics, Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Low-dose naltrexone and acetaminophen combination | Twice a day |
| DRUG | Placebo | Twice a day |
Timeline
- Start date
- 2017-08-15
- Primary completion
- 2018-07-26
- Completion
- 2018-07-26
- First posted
- 2017-06-28
- Last updated
- 2021-04-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03201393. Inclusion in this directory is not an endorsement.