Pain Clinical Trial
Official title:
A Phase 3 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
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.
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.
The study will also endeavor to determine
- the physicians' global evaluation of CL-108 as a treatment for moderate to severe acute
pain associated with osteoarthritis of the knee or hip
- the patients' global impression of change in pain after treatment of moderate to severe
acute pain associated with osteoarthritis of the knee or hip
- any change in the patient's quality of life after treatment of moderate to severe acute
pain associated with osteoarthritis of the knee or hip
- the percentage change in pain intensity after treatment of moderate to severe acute
pain associated with osteoarthritis of the knee or hip
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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