Rheumatoid Arthritis Clinical Trial
— HZ-CA-304Official title:
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)
The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.
Status | Completed |
Enrollment | 179 |
Est. completion date | October 2008 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 81 Years |
Eligibility |
Inclusion Criteria: - Expected to continue to require daily administration of an NSAID for at least the coming 6 months. - Subject completed the 24-week Treatment period of either Horizon Protocol HZ-CA-301 or HZ-CA-303 Exclusion Criteria: - Subject didn't meet all of the Inclusion and Exclusion Criteria for Horizon Protocol HZ-CA-301 or HZ-CA-303 - Subject developed or experienced any of the following while on either HZ-CA-301 or HZ-CA-303 - Malignant Disease of the gastrointestinal tract - Erosive esophagitis - Clinically significant cardiac, renal or hepatic disease - Uncontrolled diabetes - Positive pregnancy test on Study Day 0 - Please note that there are other additional criteria. The study center will determine if you meet all of the criteria. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | PRA International | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Horizon Pharma Ireland, Ltd., Dublin Ireland |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Treatment Emergent Adverse Events | The objective of this study was to evaluate the long term safety of HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg). No efficacy analyses were planned or performed. Adverse event information was elicited from each participant by indirect questioning using a non-leading question, such as "Has anything bothered you since your last visit or is anything bothering you now?" Adverse event data may also have been volunteered by the participant to the investigator or designee. Physicians assessed the seriousness, severity and causality of each adverse event. | 28 weeks | Yes |
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