drugset / Trial / NCT02542098
Safety, Pharmacokinetics (PK), and Effectiveness of Hydrocodone Bitartrate (HYD) Extended-Release Tablets in Children
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and effectiveness of Hydrocodone Bitartrate (HYD) tablets in children with moderate to severe pain requiring around-the-clock opioid analgesics.
Timeline
- Start
- 2017-01
- Primary completion
- 2019-07
- Completion
- 2019-07
Outcome
Outcome not reported
Stopped: “Study has been updated with a new protocol number”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydrocodone bitartrate | Unknown | 20 mg | Oral |
| Subject | Hydrocodone bitartrate | Unknown | 120 mg | Oral |
Indications
No indication recorded.