Phase 3
Completed N=179
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)
Source: ClinicalTrials.gov NCT00613106 ↗Enrolled (actual)
179
Serious AEs
2.8%
Results posted
Jun 2011
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events — 55; 16 participants — p=0.4228
Summary
The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events |
55; 16 | 0.4228 |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00613106). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.