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Also known as Tapentadol IR capsule, Tapentadol IR (CG5503)
Tapentadol IR · 3 trials · 2 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.
| 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 |
| 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 |
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 developed by Johnson & Johnson (ticker JNJ) for acute pain. It has been studied in Phase 3 trials for postoperative pain and for pain following bunionectomy surgery for hallux valgus. Tapentadol IR is also known as Tapentadol IR capsule, Tapentadol IR (CG5503), and Tapentadol IR 50 mg.
Tapentadol IR targets SLC6A2 and OPRM1. It acts as an inhibitor at these targets, combining norepinephrine reuptake inhibition with mu-opioid receptor activity. This dual mechanism is intended to provide analgesia through both opioid and non-opioid pathways.
Johnson & Johnson, which trades under the ticker JNJ, is the developer of Tapentadol IR. The company has sponsored Phase 3 clinical trials of the immediate-release formulation in acute pain settings, including postoperative pain and pain after bunionectomy for hallux valgus.
Tapentadol IR is in Phase 3 clinical development. It is investigational and has been evaluated in completed Phase 3 trials. The program includes two completed trials with a combined enrollment of 413 participants, both randomized, double-blind, and placebo-controlled.
Tapentadol IR has been studied in completed Phase 3 trials including NCT01813890 in Taiwan, NCT01516008 in South Korea, and NCT00814580. The first two evaluated Tapentadol (CG5503) for acute pain from bunionectomy in hallux valgus, while NCT00814580 assessed acute postoperative pain after elective arthroscopic shoulder surgery.
Yes, Tapentadol IR (CG5503) is an alternative name for Tapentadol IR. Other names used for the same asset include Tapentadol IR capsule and Tapentadol IR 50 mg. These refer to the immediate-release formulation developed by Johnson & Johnson.