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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00568295 | A Four-Week Study Comparing Acetaminophen Extended Release and Rofecoxib in the Treatment of Osteoarthritis of the Knee | PHASE3 | COMPLETED | 403 | — | — | Oct 1, 1999 | Oct 1, 2000 | Aug 22, 2011 | - | — |
| Arm | Type | Description |
|---|---|---|
| Acetaminophen | EXPERIMENTAL | Acetaminophen Extended Release: Caplets 650 mg x 2, oral, C-112-10AP |
| Refecoxib 12.5 mg | ACTIVE_COMPARATOR | Rofecoxib: Capsules 12.5 mg, oral, C-904-1A |
| Rofecoxib 12.5 x 2 | ACTIVE_COMPARATOR | Rofecoxib: Capsules 12.5 mg x 2, oral, C-904-1A |
| Name | Type | Description |
|---|---|---|
| acetaminophen | DRUG | Acetaminophen Extended Release: Caplets 650 mg x 2, oral, C-112-10AP - Subjects were instructed to dose every eight hours according to the specified dosing schedule and to record the designated parameters in the subject diary on a daily basis throughout the course of the study until the final visit at the end of Week 4 or until discontinuation of study medication. |
| Rofecoxib | DRUG | Rofecoxib: Capsules 12.5 mg, oral, C-904-1A - - Subjects were instructed to dose every eight hours according to the specified dosing schedule and to record the designated parameters in the subject diary on a daily basis throughout the course of the study until the final visit at the end of Week 4 or until discontinuation of study medication. |
Inclusion Criteria: * Symptomatic idiopathic osteoarthritis of the knee for a minimum of six months duration requiring treatment with either an analgesic or anti-inflammatory agent on a regular basis (greater than or equal to three days/week) for at least three months. * A history of osteoarthritis...