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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00404183 | A Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR)and Placebo in Subjects With Osteoarthritis | PHASE2 | COMPLETED | 120 | — | — | Aug 1, 2004 | - | Jan 19, 2011 | - | — |
Arthritis Pain Intensity measured by a 100mm Visial Analog Scase (VAS)
| Arm | Type | Description |
|---|---|---|
| hydrocodone/acetaminophen extended release | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Extended-Release Hydrocodone/Acetaminophen | DRUG | 2 tablets BID |
| Placebo | DRUG | 2 tablets BID |
Inclusion Criteria: * Males or females ages 21 to 75 * Has osteoarthritis of the hip or knee * Requires therapeutic doses of medications for osteoarthritis * If female, must be of non-childbearing potential or practicing birth control * Has sufficient pain to justify the use of round-the-clock opio...