Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tapentadol IR · 5 trials · 4 indications
Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 48 hours. Total score ranges from -480 (worst) to 480 (best) for SPID48. A higher value of SPID indicates greater pain relief.
Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 48 hours. Total score ranges from -480 (worst) to 480 (best) for SPID48. A higher value of SPID indicates greater pain relief.
Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID72 was calculated as the time-weighted Sum of PID scores over 72 hours. The range of SPID72 is from -720 to 720. The higher value in SPID indicates greater pain relief.
Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID72 was calculated as the time-weighted Sum of PID scores over 72 hours. The range of SPID72 is from -720 to 720. The higher value in SPID indicates greater pain relief. The study was terminated prematurely due to slow enrollment after 108 of 600 subjects enrolled. Valid statistical conclusions cannot be made due to the low number of subjects.
14 blood samples for the determination of serum concentrations were taken at pre-dose and up to 48 hours after administration of the CG5503 IR capsule. The evaluation of the maximum observed serum concentration (Cmax) was based on the CG5503 base concentrations measured in serum samples using a validated liquid chromatography/tandem mass spectrometry (LC-MS/MS) method.
14 blood samples for the determination of serum concentrations were taken at pre-dose and up to 48 hours after administration of the CG5503 IR capsule. The evaluation of the area under the concentration time curve (AUC) from 0 hours to time t (=48 hours) (AUC0-t) was based on the CG5503 base concentrations measured in serum samples.
14 blood samples for the determination of serum concentrations were taken at pre-dose and up to 48 hours after administration of the CG5503 IR capsule. The AUC from 0 hours to infinity (AUC0-inf) was extrapolated from the AUC from administration to the last measured concentration.
| Arm | Type | Description |
|---|---|---|
| Tapentadol IR 50 mg | EXPERIMENTAL | - |
| Tapentadol IR 75 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| 001 | EXPERIMENTAL | Tapentadol IR First dose: one 50 mg capsule (a re-dose of 50 mg is permitted as soon as one hour after the first dose on Day 1 if needed) Subsequent doses: one or two capsules (50 mg or 100 mg) every 4 to 6 hours as needed |
| 002 | ACTIVE_COMPARATOR | Oxycodone IR First dose: one 5 mg capsule (a re-dose of 5 mg is permitted as soon as one hour after the first dose on Day 1 if needed Subsequent doses: one or two capsules (5 mg or 10 mg) every 4 to 6 hours as needed |
| 003 | PLACEBO_COMPARATOR | placebo 1 capsule every 4 - 6 hr as needed for up to 10 days |
| Tapentadol IR | EXPERIMENTAL | A single oral dose of tapentadol IR was administered in a fasted state (Treatment A). |
| Omeprazole, Tapentadol IR | EXPERIMENTAL | Oral doses of omeprazole were administered once daily in a fasted state on 4 consecutive days (Days -3 to 1), plus 1 capsule of CG5503 IR administered 2 hours after the administration of omeprazole on Day 1 (Treatment B). |
| Name | Type | Description |
|---|---|---|
| Tapentadol IR 50 mg | DRUG | Tapentadol IR 50 mg will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period. |
| Tapentadol IR 75 mg | DRUG | Tapentadol IR 75 mg will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period. |
| Placebo | DRUG | Placebo will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period. |
| Tapentadol IR | DRUG | First dose: one 50 mg capsule (a re-dose of 50 mg is permitted as soon as one hour after the first dose on Day 1, if needed) Subsequent doses: one or two capsules (50 mg or 100 mg) every 4 to 6 hours as needed |
| Oxycodone IR | DRUG | First dose: one 5 mg capsule (a re-dose of 5 mg is permitted as soon as one hour after the first dose on Day 1, if needed Subsequent doses: one or two capsules (5 mg or 10 mg) every 4 to 6 hours as needed |
| Tapentadol IR capsule | DRUG | Tapentadol IR capsule containing 93 mg tapentadol hydrochloride. |
| Omeprazole capsule | DRUG | Omeprazole capsule containing 40 mg omeprazole. |
Inclusion Criteria: * Patients must be undergoing primary unilateral first metatarsal bunionectomy that includes a distal Chevron osteotomy only, with or without the Akin procedure * Patients must be healthy or medically stable on the basis of clinical laboratory tests performed at screening * Wome...
Tapentadol IR is an immediate-release small molecule being studied for acute pain conditions, including postoperative pain following shoulder surgery and acute pain from bunionectomy (hallux valgus). It is also being evaluated in pharmacokinetic studies. The drug is in Phase 3 clinical development and is not yet approved.
Tapentadol IR is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is currently in Phase 3 clinical trials for acute pain indications, including postoperative pain and pain from bunionectomy.
Tapentadol IR is in Phase 3 clinical development. It has completed two Phase 3 trials for acute pain from bunionectomy and postoperative pain following shoulder surgery. The drug is investigational and has not been approved by regulatory authorities.
Tapentadol IR has completed several clinical trials. NCT00814580 studied its safety and efficacy for postoperative pain after arthroscopic shoulder surgery with 382 participants. NCT01516008 and NCT01813890 evaluated it for acute pain from bunionectomy, enrolling 353 and 60 participants respectively. NCT03979989 was a Phase 1 pharmacokinetic drug interaction study.
Yes, Tapentadol IR is also known as CG5503. Clinical trial records refer to the drug by both names, such as in NCT01813890, which studied Tapentadol (CG5503) for acute pain from bunionectomy. This alternative name appears in pharmacokinetic and efficacy studies of the drug.