NCT00613106

Double-Blind Follow-on Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg) in Subjects Who Have Completed Participation in HZ-CA-301 (NCT00450658) or HZ-CA-303 (NCT00450216)

Double-Blind Follow-On Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg)in Subjects Who Have Completed Participation in Horizon Protocol HZ-CA-301 (NCT00450658)or Horizon Protocol HZ-CA-303 (NCT00450216)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 179 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 40 Years – 81 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis
• Rheumatoid Arthritis
• Chronic Low Back Pain
• Chronic Regional Pain Syndrome
• Chronic Soft Tissue Pain

Interventions

Type	Name	Description
DRUG	HZT-501	Ibuprofen 800mg/famotidine 26.6 mg administered orally 3 times daily for 2 weeks
DRUG	Ibuprofen	Ibuprofen 800mg administered orally 3 times daily for at least 28 weeks

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-02-12
• Last updated: 2024-12-17
• Results posted: 2011-06-17

Locations

1 site across 1 country: United States