Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Celecoxib
celecoxib reference formulation · 8 trials · 6 indications
The patient impression of the study medication was entered in the patient diary based on the following categories: "excellent," "good," "fair" and "poor." Efficacy was based on the patient impression of the study medication ("excellent" and "good") from the first study medication until Final Visit.
100-millimeter (mm) Visual Analog Scale (VAS) score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question "What has been your global pain intensity in the last 48 hours?" 0=no pain to 100=worst pain. Change from baseline of less than (\<) 0 indicated improvement.
100-mm VAS scores specified participant's assessment of global pain intensity in the previous 48 hours, in response to the following question "What has been your global pain intensity in the last 48 hours?" 0=no pain to 100=worst pain. Lower scores indicated less pain.
The Patient's Pain Intensity in the Index Joint for the prior 24 hours was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate (2), Severe (3), or Extreme (4).
A subject who met the following criteria was considered as a successful responder at Week 6: completed 6 weeks of treatment with study medication and had a 30% improvement from Baseline to Week 6/ET on the NRS-Pain. NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain).
Based on the Pain Intensity scores measured on a Visual Analogue Scale (PI-VAS: 0mm=no pain,100mm=worst possible pain), assessed by the subjects, the SPID2 is the area under the curve (AUC) over the 2-hour period post-first dose of the Pain Intensity Difference (PID) scores using the trapezoidal rule.
Patient's impression was assessed by self-report and was entered in the patient diary, based on the following categories: "Excellent", " Good", "Fair" and "Poor". Efficacy rate was calculated from the following formula, "The number of participants assessed as Excellent or Good" over "total participants" multiplied by 100.
| Arm | Type | Description |
|---|---|---|
| Celecoxib | EXPERIMENTAL | - |
| Celecoxib 200 mg QD | EXPERIMENTAL | - |
| Diclofenac SR 75 mg QD | ACTIVE_COMPARATOR | - |
| 1 | ACTIVE_COMPARATOR | - |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| 4 | EXPERIMENTAL | - |
| tramadol | ACTIVE_COMPARATOR | - |
| celecoxib 50 mg/50 mg | EXPERIMENTAL | - |
| celecoxib 100 mg/placebo | EXPERIMENTAL | - |
| celecoxib 100 mg/50 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Celecoxib 400mg | EXPERIMENTAL | - |
| Celecoxib 200mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Celecoxib | DRUG | Day 1 * The first dose: Celecoxib 400mg * The second dose: Celecoxib 200mg during a period between 6 hours post-first dose and before bed Days 2 to 8 (Study drug should be taken until the dose scheduled after breakfast on the day of Day 8) \- Celecoxib 200mg twice daily |
| Diclofenac SR | DRUG | tablet, 75 mg QD,6-12 weeks |
| Indomethacin | DRUG | indomethacin 50 mg three times a day (TID) for 8 days. |
| tramadol HCL | DRUG | 50 mg capsules QID for 6 weeks |
| placebo | DRUG | dose 1 placebo followed 6-12 hours later by dose 2 placebo |
| Loxoprofen | DRUG | - |
| celecoxib and ibuprofen SR | DRUG | - |
Inclusion Criteria: * Patients with posttraumatic pain which is able to be controlled with an oral NSAID * Patients with "pain" that meets both of the following criteria within 48 hours after injury: "Pain" Pain intensity (Categorical): "Moderate pain" or "Severe pain" Pain intensity (VAS): 45.0 m...
Top 6 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 1 | PHASE2 | Tulisokibart |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY002-072 |
| XBiotech, Inc. | XBIT | 1 | PHASE2 | vilamakitug |
| Novartis AG Sponsored ADR | NVS | 2 | - | Secukinumab |
| AbbVie, Inc. | ABBV | 1 | - | Upadacitinib |
| Pfizer Inc. | PFE | 1 | - | tofacitinib |