Double-Blind Follow-on Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg) in Subjects … (NCT00613106) | Clinical Trial Compass
CompletedPhase 3
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)
United States179 participantsStarted 2007-09
Plain-language summary
The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.
Who can participate
Age range40 Years – 81 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Number of Participants With Treatment Emergent Adverse Events