drugset / Trial / NCT02462850
A Multi-Center Actual-Use Study on the Safety of CL 108 for the Treatment of Moderate to Severe Acute Pain Associated With Osteoarthritis of the Knee or Hip
NaSingle-groupOpen-labelTreatment
Summary
The purpose of CLCT-006, a multi-center open-label study, is to evaluate the safety of CL-108 (hydrocodone 7.5 mg/APAP 325 mg, promethazine 12.5 mg) for the treatment of moderate to severe acute pain ("flare") associated with osteoarthritis of the knee or hip under actual conditions of use.
Timeline
- Start
- 2014-10
- Primary completion
- 2015-01
- Completion
- 2015-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 325 mg | — |
| Subject | Hydrocodone | Unknown | 7.5 mg | — |
| Subject | Promethazine | Small molecule | 12.5 mg | — |
Indications
No indication recorded.