Conditions: Osteoarthritis Rheumatoid Arthritis Chronic Low Back Pain Chronic Regional Pain Syndrome Chronic Soft Tissue Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 179
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.

Detailed description:
Subject who have completed the 24-week Treatment Period of Horizon Protocol HZ-CA-301 or HZ-CA-303 without developing an upper gastrointestinal ulcer and who are expected to continue to require daily administration of an NSAID for the next 6 months will receive treatment with the same study medication received while participating in HZ-CA-301 or HZ-CA-303.

Study with completed results acquired from Horizon in 2024.

Arms:
arm 1: HZT-501: ibuprofen 800mg/famotidine 26.6mg arm 2: Ibuprofen 800mg

Interventions: intervention 1: HZT-501 intervention 2: Ibuprofen
Intervention descriptions: intervention 1: Ibuprofen 800mg/famotidine 26.6 mg administered orally 3 times daily for 2 weeks intervention 2: Ibuprofen 800mg administered orally 3 times daily for at least 28 weeks

Protocol document: