An interventional study of Addinex and Standard Pill Bottle in Bone Fractures, sponsored by Addinex Technologies, Inc.. Completed at 1 site in United States. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Addinex Technologies, Inc. · Not applicable, Interventional, and Treatment
Among 192 studies in Fractures, Bone with a site in United States — 37 open to participants now, 43 under way, 2 of them phase 3. Fractures, Bone · United States.
Among the 192 studies in Fractures, Bone with a site in United States, this one is the 60th largest by enrollment of the 129 interventional ones, is one of 10 that started in 2025, is one of 64 with no phase, and was the 175th registered.
723 studies on the registry are indexed under Fractures, Bone; 114 are open to participants now.
This study's enrollment of 95 is above the median of 80 across 458 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →37 of the 192 studies in Fractures, Bone with a site in United States are open now, in 8 countries. Each count lists the studies.
Of the 70 Fractures, Bone studies recruiting now, 35 (50%) set no upper age limit and 21 (30%) stop at 75 or younger; 17 take children under 18; 14 take healthy volunteers.
This study: 6 Years and older · all sexes · no healthy volunteers.
The full table on the hub →192 studies; the count open now beside each. This study's row is marked.
First in 1991; this study’s year is marked. 10 started in 2025.
Median enrollment 87 across the 129 interventional studies, 100 across the 63 observational. Of the 134 that completed or were terminated, 54 (40%) have results posted.
48 of 192 have an industry lead sponsor. The 10 most frequent:
Addinex Technologies, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Addinex Technologies, Inc. has 1 study filed under Fractures, Bone — fewer than ten, so there is no comparison to draw.
14 of the studies in Fractures, Bone with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05699174Phase 3Major Extremity Trauma Research ConsortiumPO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation | 2027-09 |
| NCT06450639Hoffmann-La RocheA Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD) | 2026-11-18 |
| NCT05824676Hartford HospitalDePuy Synthes Variable Angle LCP Patella Plating System Study | 2026-12 |
| NCT07430345The Cooper Health SystemBuprenorphine for Analgesia in Older Adults With Acute Fractures in the Emergency Department | 2026-12 |
| NCT06256458Artoss Inc.Prospective Registry to Evaluate Outcomes of NanoBone® Bone Graft in Acute Trauma | 2026-12-01 |
Among the 192 studies in Fractures, Bone with a site in United States, from their registry updates:
The goal of this study is to analyze the use of the Addinex system for opioid dispensing after ambulatory care to determine whether it will reduce opioid consumption, increase pill disposal, show variables that may predict opioid consumption, and determine whether this intervention is acceptable to patients.
Prescription opioids remain a popular drug class with 143 million (M) opioid prescriptions written in 2020. In that same year, 8.7 million people (2.6% of the US population) misused prescription pain relievers, and overdose deaths from opioids continue to rise to 83,695 in 2022. Across six studies, 67% to 92% of patients prescribed opioids reported unused pills. In 2017, patients were prescribed 3.3 billion excess pills, yet no more than 9% of patients properly disposed of their unused opioids. Despite attempts to reduce overprescribing, increase disposal, and decrease diversion, these issues still contribute to increasing misuse, addiction, and overdose deaths.
Addinex Technologies has developed a novel system to reduce the use of opioids through controlling, monitoring, and disposing of excess opioids. The unique "closed-loop" system starts with clinicians prescribing opioids with the Addinex system. Addinex's partner pharmacy then fills the patented dispenser and delivers it to the patient. The patient uses the Addinex app to access each individual dose code and to obtain education and feedback. Finally, the patient returns the dispenser with any excess pills in a DEA-approved mailer to Addinex's partner disposal company. In a study with Columbia University Medical Center using the Addinex system with 30 post-surgical cancer patients, results showed 70% fewer pills used than prescribed, 60% fewer refills for the same surgeries, and an 84% excess pill disposal rate.
Addinex is now partnering with Brown Emergency Medicine and Rhode Island Hospital ("Brown") to perform a feasibility study using Addinex\'s system. We will conduct a clinical trial involving 100 patients with extremity fractures treated by the emergency department. Half the patients (25 adults and 25 minors) will utilize the Addinex system, while the other half will have their opioids dispensed in a standard pill bottle as the control group. Addinex's system promotes the return of medication using a pre-paid disposal mailer once patients have completed their course of treatment. The clinical study\'s main goals involve evaluating the system\'s effectiveness with patients obtaining same day treatment. This evaluation will encompass an analysis of medication consumption, disposal rates, pain levels, the impact of monitoring policies, and ensuring that the established commercial protocols function seamlessly. Ultimately, the project aims to demonstrate that the Addinex system can successfully operate within the broader hospital environment (same day and scheduled procedures), controlling and monitoring opioid usage, promoting patient well-being, and lowering costs.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in this arm will be adults who undergo standard at-home acute pain management with opioids after treatment for isolated bone fracture (n=25)
Device: Standard Pill Bottle
Patients in this arm will be children who undergo standard at-home acute pain management with opioids after treatment for isolated bone fracture (n=25)
Device: Standard Pill Bottle
Patients in this arm will be adults who undergo at-home acute pain management using the Addinex system after treatment for isolated bone fracture (n=25)
Device: Addinex
Patients in this arm will be children who undergo at-home acute pain management using the Addinex system after treatment for isolated bone fracture (n=25)
Device: Addinex
Medication dispensing system to control and monitor opioid use
Access and use of opioids in a standard pill bottle.
Median pill consumption
Patients are expected to consume at least 16% fewer pills/MMEs using the Addinex system as compared to the control group.
Time frame: One month post treatment
Median disposal of opioids
Patients are expected to dispose of at least 50% of excess opioid pills using the Addinex system vs. 20% in the control group.
Time frame: 12 months post treatment
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2025 to primary completion in Aug 2026, 14 months.
Of 166 interventional studies with no phase under Fractures, Bone, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 57. This study's 14 months is below that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 3, 2026: primary completion May 2026 → Aug 2026 and completion Jun 2026 → Aug 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Addinex Technologies, Inc.