Conditions: Osteoarthritis Rheumatoid Arthritis Chronic Low Back Pain Chronic Regional Pain Syndrome Chronic Soft Tissue Pain
Keywords: NSAID Chronic Pain Osteoarthritis Rheumatoid Arthritis
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 86
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety of long-term treatment with HZT-501, a fixed-dose combination oral tablet of 800 mg ibuprofen and 26.6 mg famotidine for patients that require long-term NSAID treatment.

Detailed description:
HZT-501, a fixed-dose combination of ibuprofen, a pain and inflammation relieving non-steroidal anti-inflammatory drug (NSAID), and famotidine, a histamine type 2 receptor antagonist (H2RA), is being developed for the treatment of patients with signs and symptoms of osteoarthritis, rheumatoid arthritis, mild to moderate pain or dysmenorrhea who are at risk of developing ibuprofen-associated upper gastrointestinal ulcers.

Study with completed results acquired from Horizon in 2024.

Arms:
arm 1: Open-label treatment with HZT-501

Interventions: intervention 1: HZT-501
Intervention descriptions: intervention 1: Fixed-dose combination oral tablet 800mg Ibuprofen/26.6 mg Famotidine taken three times per day

Protocol document: