Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00984815 | Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment | PHASE3 | COMPLETED | 86 | — | — | Sep 1, 2009 | Jul 1, 2011 | Dec 18, 2024 | 4 | United States |
| 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) | PHASE3 | COMPLETED | 179 | — | — | Sep 1, 2007 | Oct 1, 2008 | Dec 17, 2024 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| HZT-501 | EXPERIMENTAL | Open-label treatment with HZT-501 |
| Ibuprofen | ACTIVE_COMPARATOR | Ibuprofen 800mg |
| Name | Type | Description |
|---|---|---|
| HZT-501 | DRUG | Fixed-dose combination oral tablet 800mg Ibuprofen/26.6 mg Famotidine taken three times per day |
| Ibuprofen | DRUG | Ibuprofen 800mg administered orally 3 times daily for at least 28 weeks |
Inclusion Criteria: * Patient is capable of understanding the purpose and risks of the study and is able to provide written Informed Consent. * Patient is male or female, aged 40 to 80 years of age. * Patient is expected to require daily administration of an NSAID for at least the coming year for c...