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Also known as tapentadol (CG5503) Immediate Release IR
tapentadol Immediate Release IR · 1 trial · 1 indication
For this twice daily pain assessment, the subjects were to indicate the level of average pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | tapentadol (CG5503) Immediate Release (IR) Following open label period is 2 double blind periods: Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER 100 150 200 or 250 mg tablets twice daily in second or Tapentadol ER in first intervention period of double-blind phase and Tapentadol IR in second,tapentadol (CG5503) Immediate Release IR 21 day Open Label: an adjustable dose of Tapentadol IR 50-100mg orally every 4-6 hours to maximum total daily dose (TDD) dose of 500 mg during open label period |
| 002 | EXPERIMENTAL | tapentadol (CG5503) Extended Release (ER) During 2 double blind periods: Tapentadol ER 100 150 200 or 250 mg tablets twice daily in the first intervention period of double-blind phase and Tapentadol IR in the second or Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER in second |
| Name | Type | Description |
|---|---|---|
| tapentadol (CG5503) Immediate Release IR | DRUG | 21 day Open Label: an adjustable dose of Tapentadol IR 50-100mg orally every 4-6 hours to maximum total daily dose (TDD) dose of 500 mg during open label period |
| tapentadol (CG5503) Extended Release (ER) | DRUG | During 2 double blind periods: Tapentadol ER 100, 150, 200 or 250 mg tablets twice daily in the first intervention period of double-blind phase and Tapentadol IR in the second or Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER in second |
| tapentadol (CG5503) Immediate Release (IR) | DRUG | Following open label period is 2 double blind periods: Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER 100, 150, 200 or 250 mg tablets twice daily in second or Tapentadol ER in first intervention period of double-blind phase and Tapentadol IR in second |
Inclusion Criteria: * Diagnosis of Low Back Pain (LBP) of non-malignant origin present for at least 3 months immediately before study entry * Taking drug treatment for pain for at least 3 months before screening and who are dissatisfied with current therapy * Subjects receiving opioid treatment mus...
Top 1 of 5 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE2 | LY4065967 |
Tapentadol Immediate Release IR is an investigational immediate-release small molecule developed by Johnson & Johnson (JNJ) for low back pain. It is in Phase 3 clinical development and has been studied in a completed Phase 3 trial in patients with chronic low back pain. It is not described as approved.
Tapentadol Immediate Release IR is being studied for the treatment of low back pain. The completed Phase 3 trial enrolled patients with chronic low back pain. Its development is focused on this pain indication.
Tapentadol Immediate Release IR targets SLC6A2 and OPRM1. SLC6A2 is a norepinephrine transporter, and OPRM1 is the mu-opioid receptor. The drug is classified as an inhibitor against these targets.
Tapentadol Immediate Release IR is developed by Johnson & Johnson, which trades under the ticker JNJ.
Tapentadol Immediate Release IR is in Phase 3 development. It is investigational and has not been described as FDA approved. One Phase 3 trial has been completed.
Tapentadol Immediate Release IR has been studied in the completed Phase 3 trial NCT00594516, titled a study on the safety and effectiveness of switching between two forms of tapentadol in patients with chronic low back pain. It enrolled 117 patients, was randomized, double-blind, and controlled.
Yes, tapentadol Immediate Release IR is also known as tapentadol (CG5503) Immediate Release IR. CG5503 is an alternative designation for the same investigational immediate-release small molecule developed by Johnson & Johnson for low back pain.