Clinical Trial: Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Open-Label Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-Steroidal Anti-Inflammatory Drug Treatment

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 Summary: 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.
Sponsor: Horizon Pharma Ireland, Ltd., Dublin Ireland

Current Primary Outcome: Number of Participants With Treatment Emergent Adverse Events [ Time Frame: 54 weeks ]

Original Primary Outcome: The safety of HZT-501 will be measured by adverse events, physical examinations (including vital signs and weight), and clinical laboratory assessments. [ Time Frame: One year ]

Current Secondary Outcome:

• Change From Baseline in the Pain Intensity Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks [ Time Frame: Baseline and 54 Weeks ]
  The pain intensity scale of the SODA questionnaire ranges from 2 - 47. Change from baseline compares the score at Week 54 to the baseline score for each participant who completed the pain intensity questions of the SODA questionnaire at baseline and Week 54. Higher scores indicate greater symptom severity and therefore a negative mean change from baseline is indicative of an improvement in symptoms.
• Change From Baseline in the Non-pain Symptoms Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks [ Time Frame: Baseline and 54 Weeks ]
  The non-pain symptom scale of the SODA questionnaire ranges from 7 - 35. Change from baseline compares the score at Week 54 to the baseline score for each participant that completed the non-pain symptom questions of the SODA questionnaire at baseline and Week 54. Higher scores indicate greater symptom severity and therefore a negative mean change from baseline is indicative of an improvement in symptoms.
• Change From Baseline in the Satisfaction With Dyspepsia-Related Health Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks [ Time Frame: Baseline and 54 Weeks ]
  The satisfaction with dyspepsia-related health scale of the SODA questionnaire ranges from 2 - 23. Change from baseline compares the score at Week 54 to the baseline score for each participant who completed the Satisfaction questions of the SODA questionnaire at baseline and Week 54. A positive change from baseline in the SODA satisfaction scale represents a participant's overall improved satisfaction with their dyspepsia-related health.

Original Secondary Outcome: Severity of Dyspepsia Assessment Questionnaire (SODA) will be completed by the patients to assess tolerability every six weeks. [ Time Frame: One year ]

Information By: Horizon Pharma Ireland, Ltd., Dublin Ireland

Dates:
Date Received: September 23, 2009
Date Started: September 2009
Date Completion:
Last Updated: June 19, 2013
Last Verified: June 2013