Conditions: Osteoarthritis Low Back Pain
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 376
Healthy volunteers: no

Brief summary:
The primary objective is to demonstrate the safety and tolerability of COV795 with up to 35 days use as evaluated by physical exam, vital signs, pulse oximetry, clinical laboratory tests, and other adverse events (AEs).

Detailed description:

Arms:
arm 1: Participants receive 2 tablets of COV795 every 12 hours for up to 35 days

Interventions: intervention 1: COV795
Intervention descriptions: intervention 1: COV795 is a multilayer extended-release tablet for oral administration of oxycodone hydrochloride (15 mg) and acetaminophen (650 mg)

Protocol document: