drugset / Trial / NCT02680847
Safety and Pharmacokinetic Study of ALO-02 in Children Ages 7-17 With Pain
Open-labelTreatment
Summary
Safety and pharmacokinetics of an abuse-deterrent, extended-release formulation of oxycodone hydrochloride with a sequestered naltrexone core in children 7-17 with moderate-severe pain.
Timeline
- Start
- 2016-01-21
- Primary completion
- 2018-01-10
- Completion
- 2018-01-24
Outcome
Outcome not reported
Stopped: “The trial was terminated on 08FEB2018. Pfizer has decided to withdraw the New Drug Application and has notified FDA. There are no efficacy or safety concerns.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ALO-02 | Unknown | — | Oral |
Indications
No indication recorded.