Conditions: Ulcer
Keywords: ibuprofen famotidine ulcers NSAIDS pain arthritis chronic regional pain syndrome chronic soft tissue pain osteoarthritis rheumatoid arthritis chronic low back pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 906
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen.

Detailed description:
HZT-501 is a combination product including ibuprofen and the acid reducing agent famotidine. The study is designed to determine whether the combination product reduces the rate of ulcer development in subjects who require long-term daily use of ibuprofen.

Subjects will be assigned randomly, in approximately a 2:1 ratio, to treatment with either HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) or ibuprofen (800 mg) three times daily for a 24 week treatment period or until they develop either an endoscopically-diagnosed upper gastrointestinal ulcer and/or prohibitive toxicity. Subjects will visit the study center for Screening and at Weeks 4, 8, 16, and 24. Physical exams will be performed, and clinical laboratory measurements made, at selected times during the study. Endoscopic exams will be performed during Screening and at Weeks 8, 16, and 24. Subjects will be contacted four weeks following study completion.

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: Ibuprofen/famotidine intervention 2: Ibuprofen
Intervention descriptions: intervention 1: HZT-501: Ibuprofen800mg/famotidine 26.6mg administered orally 3 times daily for 24 weeks intervention 2: Ibuprofen 800mg administered orally 3 times daily for 24 weeks

Protocol document: