Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-04457845 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| PF-04457845 followed by placebo | EXPERIMENTAL | - |
| Placebo followed by PF-04457845 | EXPERIMENTAL | - |
| Naproxen followed by placebo | ACTIVE_COMPARATOR | - |
| Placebo followed by Naproxen | ACTIVE_COMPARATOR | - |
| Healthy adult volunteers | EXPERIMENTAL | Standard Phase 1 normal healthy adult volunteers, age range 21-55 years and of either sex |
| Name | Type | Description |
|---|---|---|
| PF-04457845 | DRUG | PF-04457845 4 mg tablet once daily / matched placebo |
| Naproxen | DRUG | Naproxen 500 mg tablet twice daily / matched placebo |
Inclusion Criteria: * Subjects must have a diagnosis of Osteoarthritis (OA) of the knee confirmed by X-ray * Subjects must be willing and able to stop all current pain therapy for the duration of study. (Limited and specific pain therapy will be available throughout the study) * Subjects can be mal...
PF-04457845 is an investigational small molecule being studied for acute pain, chronic pain, and osteoarthritis of the knee. It has been evaluated in healthy volunteers and in patients with knee osteoarthritis. The drug is not approved and remains in clinical development.
PF-04457845 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The company has sponsored clinical trials of the drug in healthy volunteers and in patients with osteoarthritis of the knee.
PF-04457845 has completed Phase 1 and Phase 2 clinical trials. The most advanced study was a Phase 2 trial in patients with osteoarthritis of the knee. The drug is investigational and has not been approved by regulatory authorities.
PF-04457845 has been studied in three completed trials: NCT00836082, a Phase 1 multiple dose trial in healthy volunteers; NCT00918164, a Phase 1 bioavailability and food effect study; and NCT00981357, a Phase 2 trial in patients with osteoarthritis of the knee.
PF-04457845 is the primary name used in clinical trial records for this investigational drug. No alternative names have been reported in the available clinical trial information.