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CG5503 IR;tapentadol · 2 trials · 6 indications
| Name | Type | Description |
|---|---|---|
| CG5503 IR; tapentadol | DRUG | - |
| CG5503 IR;tapentadol | DRUG | - |
Inclusion Criteria: * Clinical diagnosis of chronic osteoarthritis of the hip or the knee based on clinical and radiographic (X-Ray) criteria defined by standard accepted guidelines * candidate (qualifies) for primary one-sided total or partial joint replacement surgery due to noninflammatory, end-...
Tapentadol (CG5503 IR) is being studied for the treatment of acute pain, including pain associated with arthralgia and osteoarthritis. It is an investigational immediate-release formulation developed for pain relief in musculoskeletal conditions. Clinical trials have evaluated its effectiveness and safety in patients with acute pain following bunionectomy and in patients awaiting joint replacement surgery.
Tapentadol (CG5503 IR) is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker symbol JNJ. The company is responsible for the clinical development program of this investigational pain therapy.
Tapentadol (CG5503 IR) is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA for the studied indications. The Phase 3 program includes completed trials evaluating its effectiveness and safety in acute pain and osteoarthritis-related pain.
Tapentadol (CG5503 IR) has been evaluated in two completed Phase 3 trials. NCT00364247 studied its effectiveness and safety in acute pain from bunionectomy compared with placebo, enrolling 602 patients. NCT00361582 evaluated multiple doses in patients awaiting joint replacement surgery, enrolling 669 patients. Both trials included adults aged 18 and older.
Yes, CG5503 IR and tapentadol refer to the same investigational drug. CG5503 is the development code used for tapentadol, and IR indicates the immediate-release formulation. Both names appear in the clinical trial records for this Phase 3 program.